Philip Keith, Rebecca Inez Caldino Bohn, Trung Nguyen, L. Keith Scott, Monty Richmond, Matthew Day, Carol Choe, Linda Perkins, Rebecca Burnside, Richard Pyke, Ben Rikard, Amanda Guffey, Arun Saini, H. J. Park, Joseph Carcillo
Background
Throughout the COVID-19 pandemic, the mortality of critically ill patients remained high. Our group developed a treatment regimen targeting sepsis and ARDS which we labeled “triple therapy” consisting of (1) corticosteroids, (2) therapeutic plasma exchange (TPE), and (3) timely intubation with lung protective ventilation. Our propensity analysis assesses the impact of triple therapy on survival in COVID-19 patients with sepsis and ARDS.
Methods
Retrospective propensity analysis comparing triple therapy to no triple therapy in adult critically ill COVID-19 patients admitted to the Intensive Care Unit at Lexington Medical Center from 1 March 2020 through 31 October 2021.
Results
Eight hundred and fifty-one patients were admitted with COVID-19 and 53 clinical and laboratory variables were analyzed. Multivariable analysis revealed that triple therapy was associated with increased survival (OR: 1.91; P = .008). Two propensity score-adjusted models demonstrated an increased likelihood of survival in patients receiving triple therapy. Patients with thrombocytopenia were among those most likely to experience increased survival if they received early triple therapy. Decreased survival was observed with endotracheal intubation ≥7 days from hospital admission (P < .001) and there was a trend toward decreased survival if TPE was initiated ≥6 days from hospital admission (P = .091).
Conclusion
Our analysis shows that early triple therapy, defined as high-dose methylprednisolone, TPE, and timely invasive mechanical ventilation within the first 96 hours of admission, may improve survival in critically ill septic patients with ARDS secondary to COVID-19 infection. Further studies are needed to define specific phenotypes and characteristics that will identify those patients most likely to benefit.
{"title":"Improved survival in COVID-19 related sepsis and ARDS treated with a unique “triple therapy” including therapeutic plasma exchange: A single center retrospective analysis","authors":"Philip Keith, Rebecca Inez Caldino Bohn, Trung Nguyen, L. Keith Scott, Monty Richmond, Matthew Day, Carol Choe, Linda Perkins, Rebecca Burnside, Richard Pyke, Ben Rikard, Amanda Guffey, Arun Saini, H. J. Park, Joseph Carcillo","doi":"10.1002/jca.22107","DOIUrl":"10.1002/jca.22107","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Throughout the COVID-19 pandemic, the mortality of critically ill patients remained high. Our group developed a treatment regimen targeting sepsis and ARDS which we labeled “triple therapy” consisting of (1) corticosteroids, (2) therapeutic plasma exchange (TPE), and (3) timely intubation with lung protective ventilation. Our propensity analysis assesses the impact of triple therapy on survival in COVID-19 patients with sepsis and ARDS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Retrospective propensity analysis comparing triple therapy to no triple therapy in adult critically ill COVID-19 patients admitted to the Intensive Care Unit at Lexington Medical Center from 1 March 2020 through 31 October 2021.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Eight hundred and fifty-one patients were admitted with COVID-19 and 53 clinical and laboratory variables were analyzed. Multivariable analysis revealed that triple therapy was associated with increased survival (OR: 1.91; <i>P</i> = .008). Two propensity score-adjusted models demonstrated an increased likelihood of survival in patients receiving triple therapy. Patients with thrombocytopenia were among those most likely to experience increased survival if they received early triple therapy. Decreased survival was observed with endotracheal intubation ≥7 days from hospital admission (<i>P</i> < .001) and there was a trend toward decreased survival if TPE was initiated ≥6 days from hospital admission (<i>P</i> = .091).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Our analysis shows that early triple therapy, defined as high-dose methylprednisolone, TPE, and timely invasive mechanical ventilation within the first 96 hours of admission, may improve survival in critically ill septic patients with ARDS secondary to COVID-19 infection. Further studies are needed to define specific phenotypes and characteristics that will identify those patients most likely to benefit.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22107","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139969776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Little instruction in writing manuscripts for peer review is provided in nursing school or medical school. To relatively inexperienced would-be authors, including junior physicians and allied health professionals, this avenue of professional communication may sometimes seem to be unattainable. Yet many of them are energetic and insightful, and have the potential to make contributions to the literature. This article aims to provide an explanation of the components of the peer review manuscript and advice regarding how to go about writing one so as to overcome the writer's block that inexperienced authors may frequently experience.
{"title":"Writing manuscripts for peer review","authors":"Robert Weinstein","doi":"10.1002/jca.22108","DOIUrl":"10.1002/jca.22108","url":null,"abstract":"<p>Little instruction in writing manuscripts for peer review is provided in nursing school or medical school. To relatively inexperienced would-be authors, including junior physicians and allied health professionals, this avenue of professional communication may sometimes seem to be unattainable. Yet many of them are energetic and insightful, and have the potential to make contributions to the literature. This article aims to provide an explanation of the components of the peer review manuscript and advice regarding how to go about writing one so as to overcome the writer's block that inexperienced authors may frequently experience.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139931394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura S. Connelly-Smith, James Griffin, Albert T. Leung, Francesca Gennari
Extracorporeal photopheresis (ECP) is widely used for the treatment of cutaneous T-cell lymphoma, graft-vs-host disease, and other immune-related conditions. To avoid clotting during treatment, the ECP system used must be effectively primed with an anticoagulant. Heparin is the recommended anticoagulant for the THERAKOS CELLEX System, but acid citrate dextrose-A (ACDA) is often used. We compared system performance between these two anticoagulants for this ECP system. Deidentified data for ECP device performance were obtained at each treatment session, from automatically logged Smart Cards or labels completed by device operators. We compared the effects of ACDA or heparin on overall treatment duration, buffy coat (leukocyte) collection time, photoactivation time and the number of alarms and warnings. The variability in these parameters was also assessed. Data from 23 334 treat sessions were analyzed; ACDA was used in 34.4% and heparin in 65.6%. Overall, the ECP procedure duration, buffy coat collection time and photoactivation time were numerically similar regardless of whether ACDA or heparin was used, and regardless of needle mode. Photoactivation time variability was lower with ACDA compared with heparin in all needle modes. Among treatments that were completed automatically without any operator intervention, total treatment duration and photoactivation time were significantly reduced with ACDA use in both the double- and single-needle modes. The data presented indicate that, in both double- and single-needle modes, the THERAKOS® CELLEX® integrated ECP system performed similarly with ACDA compared to heparin, although ACDA demonstrated potential benefits in reducing variability in photoactivation time.
{"title":"Real-world evidence of heparin and citrate use in extracorporeal photopheresis: A hypothesis-generating data review of device settings and performance","authors":"Laura S. Connelly-Smith, James Griffin, Albert T. Leung, Francesca Gennari","doi":"10.1002/jca.22104","DOIUrl":"10.1002/jca.22104","url":null,"abstract":"<p>Extracorporeal photopheresis (ECP) is widely used for the treatment of cutaneous T-cell lymphoma, graft-vs-host disease, and other immune-related conditions. To avoid clotting during treatment, the ECP system used must be effectively primed with an anticoagulant. Heparin is the recommended anticoagulant for the THERAKOS CELLEX System, but acid citrate dextrose-A (ACDA) is often used. We compared system performance between these two anticoagulants for this ECP system. Deidentified data for ECP device performance were obtained at each treatment session, from automatically logged Smart Cards or labels completed by device operators. We compared the effects of ACDA or heparin on overall treatment duration, buffy coat (leukocyte) collection time, photoactivation time and the number of alarms and warnings. The variability in these parameters was also assessed. Data from 23 334 treat sessions were analyzed; ACDA was used in 34.4% and heparin in 65.6%. Overall, the ECP procedure duration, buffy coat collection time and photoactivation time were numerically similar regardless of whether ACDA or heparin was used, and regardless of needle mode. Photoactivation time variability was lower with ACDA compared with heparin in all needle modes. Among treatments that were completed automatically without any operator intervention, total treatment duration and photoactivation time were significantly reduced with ACDA use in both the double- and single-needle modes. The data presented indicate that, in both double- and single-needle modes, the THERAKOS® CELLEX® integrated ECP system performed similarly with ACDA compared to heparin, although ACDA demonstrated potential benefits in reducing variability in photoactivation time.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22104","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139729781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yujung Jung, Heather A. Nelson, David Ming-Hung Lin
<div> <section> <h3> Introduction</h3> <p>Lipoprotein X (Lp-X) is an abnormal lipoprotein found in multiple disease conditions, including liver dysfunction and cholestasis. High Lp-X concentrations can interfere with some laboratory testing that may result in spurious results. The detection of Lp-X can be challenging, and there is currently a lack of consensus regarding the management of Lp-X other than treating the underlying disease.</p> </section> <section> <h3> Case Presentation</h3> <p>A 42-year-old female with Hodgkin's lymphoma treated with dexamethasone, high dose cytarabine and cisplatin and vanishing bile duct syndrome confirmed by liver biopsy presented with cholestasis, pseudohyponatremia (sodium, 113 mmol/L; reference range 136–146 mmL/L; serum osmolality, 303 mOsm/kg), and hypercholesterolemia (> 2800 mg/dL, reference range < 200 mg/dL). Lp-X was confirmed by lipoprotein electrophoresis (EP). Although she did not manifest any specific signs or symptoms, therapeutic plasma exchange (TPE) was initiated based on laboratory findings of extreme hypercholesterolemia, spuriously abnormal serum sodium, and HDL values, and the potential for short- and long-term sequelae such as hyperviscosity syndrome, xanthoma, and neuropathy. During the hospitalization, she was treated with four 1.0 plasma volume TPE over 6 days using 5% albumin for replacement fluid. After the first TPE, total cholesterol (TC) decreased to 383 mg/dL and sodium was measured at 131 mmol/L. The patient was transitioned into outpatient maintenance TPE to eliminate the potential of Lp-X reappearance while the underlying disease was treated. Serial follow-up laboratory testing with lipoprotein EP showed the disappearance of Lp-X after nine TPEs over a 10-week period.</p> </section> <section> <h3> Literature Review</h3> <p>There are seven and four case reports of Lp-X treated with TPE and lipoprotein apheresis (LA), respectively. While all previous case reports showed a reduction in TC levels, none had monitored the disappearance of Lp-X after completing a course of therapeutic apheresis.</p> </section> <section> <h3> Conclusion</h3> <p>Clinicians should have a heightened suspicion for the presence of abnormal Lp-X in patients with cholestasis, hypercholesterolemia, and pseudohyponatremia. Once Lp-X is confirmed by lipoprotein EP, TPE should be initiated to reduce TC level and remove abnormal Lp-X. Most LA techniques are not expected to be beneficial since Lp-X lacks apolipoprotein B. Therefore, we suggest that inpatient course of TPE be performed every other day until serum sodium, TC and HDL levels become normalized. Outpatient maintenance TPE may also be
{"title":"Use of therapeutic plasma exchange to remove lipoprotein X in a patient with vanishing bile duct syndrome presenting with cholestasis, pseudohyponatremia, and hypercholesterolemia: A case report and review of literature","authors":"Yujung Jung, Heather A. Nelson, David Ming-Hung Lin","doi":"10.1002/jca.22105","DOIUrl":"10.1002/jca.22105","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Lipoprotein X (Lp-X) is an abnormal lipoprotein found in multiple disease conditions, including liver dysfunction and cholestasis. High Lp-X concentrations can interfere with some laboratory testing that may result in spurious results. The detection of Lp-X can be challenging, and there is currently a lack of consensus regarding the management of Lp-X other than treating the underlying disease.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Case Presentation</h3>\u0000 \u0000 <p>A 42-year-old female with Hodgkin's lymphoma treated with dexamethasone, high dose cytarabine and cisplatin and vanishing bile duct syndrome confirmed by liver biopsy presented with cholestasis, pseudohyponatremia (sodium, 113 mmol/L; reference range 136–146 mmL/L; serum osmolality, 303 mOsm/kg), and hypercholesterolemia (> 2800 mg/dL, reference range < 200 mg/dL). Lp-X was confirmed by lipoprotein electrophoresis (EP). Although she did not manifest any specific signs or symptoms, therapeutic plasma exchange (TPE) was initiated based on laboratory findings of extreme hypercholesterolemia, spuriously abnormal serum sodium, and HDL values, and the potential for short- and long-term sequelae such as hyperviscosity syndrome, xanthoma, and neuropathy. During the hospitalization, she was treated with four 1.0 plasma volume TPE over 6 days using 5% albumin for replacement fluid. After the first TPE, total cholesterol (TC) decreased to 383 mg/dL and sodium was measured at 131 mmol/L. The patient was transitioned into outpatient maintenance TPE to eliminate the potential of Lp-X reappearance while the underlying disease was treated. Serial follow-up laboratory testing with lipoprotein EP showed the disappearance of Lp-X after nine TPEs over a 10-week period.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Literature Review</h3>\u0000 \u0000 <p>There are seven and four case reports of Lp-X treated with TPE and lipoprotein apheresis (LA), respectively. While all previous case reports showed a reduction in TC levels, none had monitored the disappearance of Lp-X after completing a course of therapeutic apheresis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Clinicians should have a heightened suspicion for the presence of abnormal Lp-X in patients with cholestasis, hypercholesterolemia, and pseudohyponatremia. Once Lp-X is confirmed by lipoprotein EP, TPE should be initiated to reduce TC level and remove abnormal Lp-X. Most LA techniques are not expected to be beneficial since Lp-X lacks apolipoprotein B. Therefore, we suggest that inpatient course of TPE be performed every other day until serum sodium, TC and HDL levels become normalized. Outpatient maintenance TPE may also be","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139706859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shahida Noushad, Abhishekh Basavarajegowda, Esha Toora, Dibyajyoti Sahoo, K M Hari Priya
Introduction
Donor vein assessment for the selection of good quality veins is crucial for a successful apheresis procedure. This study intends to find out the effectiveness of a vein assessment scoring tool (VST) used and found to be effective in selecting whole blood donors to reduce the difficulty in identifying good quality veins for the plateletpheresis procedure.
Materials and methods
This was a prospective observational study on platelet apheresis donors with the application of a VST consisting of three vein descriptor parameters (vein visibility, vein palpability, and vein size) with 5 Likert-type responses constituting a score of 0–12 for each arm. Two vein assessors independently evaluated the vein in both arms and marked their responses blinded from each other as well from the principal investigator. The scores were then calculated and analyzed at the end of the study for their association with phlebotomy and procedural outcomes.
Results
A total of 190 donors were recruited. The mean scores for the arms with successful and failed phlebotomy were 9.1 and 9.4 (SD 2.3), respectively. The intra-class correlation Alpha Cronbach value was 0.834 and 0.837 for total scoring in the left arm and right arm, respectively, between the two assessors. Scores neither showed a correlation with other outcomes like low flow alarms, hematoma formation, number of phlebotomy attempts, and procedure completion.
Conclusion
The study showed that the vein score tool did not truly predict the phlebotomy outcome in apheresis donors, though there was a good degree of inter-assessor reliability.
{"title":"Evaluation of a scoring system for vein suitability in platelet apheresis donors","authors":"Shahida Noushad, Abhishekh Basavarajegowda, Esha Toora, Dibyajyoti Sahoo, K M Hari Priya","doi":"10.1002/jca.22106","DOIUrl":"10.1002/jca.22106","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Donor vein assessment for the selection of good quality veins is crucial for a successful apheresis procedure. This study intends to find out the effectiveness of a vein assessment scoring tool (VST) used and found to be effective in selecting whole blood donors to reduce the difficulty in identifying good quality veins for the plateletpheresis procedure.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and methods</h3>\u0000 \u0000 <p>This was a prospective observational study on platelet apheresis donors with the application of a VST consisting of three vein descriptor parameters (vein visibility, vein palpability, and vein size) with 5 Likert-type responses constituting a score of 0–12 for each arm. Two vein assessors independently evaluated the vein in both arms and marked their responses blinded from each other as well from the principal investigator. The scores were then calculated and analyzed at the end of the study for their association with phlebotomy and procedural outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 190 donors were recruited. The mean scores for the arms with successful and failed phlebotomy were 9.1 and 9.4 (SD 2.3), respectively. The intra-class correlation Alpha Cronbach value was 0.834 and 0.837 for total scoring in the left arm and right arm, respectively, between the two assessors. Scores neither showed a correlation with other outcomes like low flow alarms, hematoma formation, number of phlebotomy attempts, and procedure completion.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The study showed that the vein score tool did not truly predict the phlebotomy outcome in apheresis donors, though there was a good degree of inter-assessor reliability.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139706901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Libai Chen, Jianyun Wen, Xiaoxiao Xu, Jing Du, Yongsheng Ruan, Xiaoqin Feng, Juan Li, Yuelin He, Xuedong Wu
Background
Peripheral blood stem cell (PBSC) collection in children poses challenges due to their small size, low body weight (BW), and unique pediatric physiology, especially among children weighing 20 kg (kg) or less.
Methods
PBSC collection data of both healthy children and patients with thalassemia major (TM) weighing 20 kg or less between January 2013 and December 2020 were reviewed. Moreover, PBSCs characteristics along with various aspects of efficiency and safety between healthy donors and patients with TM were compared.
Results
A total of 262 PBSC procedures were performed on 255 children. Of these, 91 procedures were carried out on 85 allogeneic healthy donors, and 171 auto-backup collections were performed on 170 patients with TM to ensure PBSC availability and prevent transplantation failure. A minimum pre-apheresis hemoglobin (HGB) level of 60 g/L was discovered to be safe and feasible in patients with TM. The median CD34+ cell dose in the PBSC product during the initial apheresis procedure was higher in healthy donors compared to patients with TM (7.29 ± 5.28 × 106 cells/kg vs5.88 ± 4.23 × 106 cells/kg, P = .043). The total CD34+ cells/kg recipient weight exhibited a positive correlation with pre-apheresis monocyte counts, but a negative correlation with donor weight. Apheresis significantly reduced hematocrit and platelet counts in the allogeneic group compared to the autologous group. Patients with TM experienced a higher occurrence of bone pain related to granulocyte colony-stimulating factor treatment. Notably, no serious complications related to PBSCs mobilization, central venous catheter placement, or the apheresis procedure were observed in either group.
Conclusions
PBSCs collection was both safe and effective in healthy children and pediatric patients with TM weighing 20 kg or less.
{"title":"Safety and efficacy of peripheral blood stem cells collection in healthy children and pediatric patients with thalassemia major weighing 20 kg or less","authors":"Libai Chen, Jianyun Wen, Xiaoxiao Xu, Jing Du, Yongsheng Ruan, Xiaoqin Feng, Juan Li, Yuelin He, Xuedong Wu","doi":"10.1002/jca.22102","DOIUrl":"10.1002/jca.22102","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Peripheral blood stem cell (PBSC) collection in children poses challenges due to their small size, low body weight (BW), and unique pediatric physiology, especially among children weighing 20 kg (kg) or less.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>PBSC collection data of both healthy children and patients with thalassemia major (TM) weighing 20 kg or less between January 2013 and December 2020 were reviewed. Moreover, PBSCs characteristics along with various aspects of efficiency and safety between healthy donors and patients with TM were compared.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 262 PBSC procedures were performed on 255 children. Of these, 91 procedures were carried out on 85 allogeneic healthy donors, and 171 auto-backup collections were performed on 170 patients with TM to ensure PBSC availability and prevent transplantation failure. A minimum pre-apheresis hemoglobin (HGB) level of 60 g/L was discovered to be safe and feasible in patients with TM. The median CD34+ cell dose in the PBSC product during the initial apheresis procedure was higher in healthy donors compared to patients with TM (7.29 ± 5.28 × 10<sup>6</sup> cells/kg vs5.88 ± 4.23 × 10<sup>6</sup> cells/kg, <i>P</i> = .043). The total CD34+ cells/kg recipient weight exhibited a positive correlation with pre-apheresis monocyte counts, but a negative correlation with donor weight. Apheresis significantly reduced hematocrit and platelet counts in the allogeneic group compared to the autologous group. Patients with TM experienced a higher occurrence of bone pain related to granulocyte colony-stimulating factor treatment. Notably, no serious complications related to PBSCs mobilization, central venous catheter placement, or the apheresis procedure were observed in either group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>PBSCs collection was both safe and effective in healthy children and pediatric patients with TM weighing 20 kg or less.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139377727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xin-Fang Zhu, Jia-Qiang Li, Tian-Tian Liu, Yuan Wang, Yao Zhong, Qing-Mei Gao, Qi Zhang, Kang-Kang Yu, Chong Huang, Ning Li, Qing Lu, Wen-Hong Zhang, Ji-Ming Zhang, Rong Xia, Jian-Ming Zheng
The purpose of this retrospective study is to compare the efficacy and safety of the centrifugal separation therapeutic plasma exchange (TPE) using citrate anticoagulant (cTPEc) with membrane separation TPE using heparin anticoagulant (mTPEh) in liver failure patients. The patients treated by cTPEc were defined as cTPEc group and those treated by mTPEh were defined as mTPEh group, respectively. Clinical characteristics were compared between the two groups. Survival analyses of two groups and subgroups classified by the model for end-stage liver disease (MELD) score were performed by Kaplan–Meier method and were compared by the log-rank test. In this study, there were 51 patients in cTPEc group and 18 patients in mTPEh group, respectively. The overall 28-day survival rate was 76% (39/51) in cTPEc group and 61% (11/18) in mTPEh group (P > .05). The 90-day survival rate was 69% (35/51) in cTPEc group and 50% (9/18) in mTPEh group (P > .05). MELD score = 30 was the best cut-off value to predict the prognosis of patients with liver failure treated with TPE, in mTPEh group as well as cTPEc group. The median of total calcium/ionized calcium ratio (2.84, range from 2.20 to 3.71) after cTPEc was significantly higher than the ratio (1.97, range from 1.73 to 3.19) before cTPEc (P < .001). However, there was no significant difference between the mean concentrations of total calcium before cTPEc and at 48 h after cTPEc. Our study concludes that there was no statistically significant difference in survival rate and complications between cTPEc and mTPEh groups. The liver failure patients tolerated cTPEc treatment via peripheral vascular access with the prognosis similar to mTPEh. The prognosis in patients with MELD score < 30 was better than in patients with MELD score ≥ 30 in both groups. In this study, the patients with acute liver failure (ALF) and acute on chronic liver failure (ACLF) treated with cTPEc tolerated the TPE frequency of every other day without significant clinical adverse event of hypocalcemia with similar outcomes to the mTPEh treatment. For liver failure patients treated with cTPEc, close clinical observation and monitoring ionized calcium are necessary to ensure the patients' safety.
{"title":"A single center retrospective study: Comparison between centrifugal separation plasma exchange with ACD-A and membrane separation plasma exchange with heparin on acute liver failure and acute on chronic liver failure","authors":"Xin-Fang Zhu, Jia-Qiang Li, Tian-Tian Liu, Yuan Wang, Yao Zhong, Qing-Mei Gao, Qi Zhang, Kang-Kang Yu, Chong Huang, Ning Li, Qing Lu, Wen-Hong Zhang, Ji-Ming Zhang, Rong Xia, Jian-Ming Zheng","doi":"10.1002/jca.22103","DOIUrl":"10.1002/jca.22103","url":null,"abstract":"<p>The purpose of this retrospective study is to compare the efficacy and safety of the centrifugal separation therapeutic plasma exchange (TPE) using citrate anticoagulant (cTPEc) with membrane separation TPE using heparin anticoagulant (mTPEh) in liver failure patients. The patients treated by cTPEc were defined as cTPEc group and those treated by mTPEh were defined as mTPEh group, respectively. Clinical characteristics were compared between the two groups. Survival analyses of two groups and subgroups classified by the model for end-stage liver disease (MELD) score were performed by Kaplan–Meier method and were compared by the log-rank test. In this study, there were 51 patients in cTPEc group and 18 patients in mTPEh group, respectively. The overall 28-day survival rate was 76% (39/51) in cTPEc group and 61% (11/18) in mTPEh group (<i>P</i> > .05). The 90-day survival rate was 69% (35/51) in cTPEc group and 50% (9/18) in mTPEh group (<i>P</i> > .05). MELD score = 30 was the best cut-off value to predict the prognosis of patients with liver failure treated with TPE, in mTPEh group as well as cTPEc group. The median of total calcium/ionized calcium ratio (2.84, range from 2.20 to 3.71) after cTPEc was significantly higher than the ratio (1.97, range from 1.73 to 3.19) before cTPEc (<i>P</i> < .001). However, there was no significant difference between the mean concentrations of total calcium before cTPEc and at 48 h after cTPEc. Our study concludes that there was no statistically significant difference in survival rate and complications between cTPEc and mTPEh groups. The liver failure patients tolerated cTPEc treatment via peripheral vascular access with the prognosis similar to mTPEh. The prognosis in patients with MELD score < 30 was better than in patients with MELD score ≥ 30 in both groups. In this study, the patients with acute liver failure (ALF) and acute on chronic liver failure (ACLF) treated with cTPEc tolerated the TPE frequency of every other day without significant clinical adverse event of hypocalcemia with similar outcomes to the mTPEh treatment. For liver failure patients treated with cTPEc, close clinical observation and monitoring ionized calcium are necessary to ensure the patients' safety.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22103","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138714534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ulcerative colitis (UC) is an inflammatory bowel disease characterized by chronic inflammation of the gastrointestinal tract, affecting millions of individuals throughout the world, and producing an impaired health-related quality of life. Granulocyte and monocyte apheresis (GMA) is a therapeutic option for UC management to induce remission by selective removal of activated leukocytes from bloodstream. Despite the knowledge of the important role of epigenetics in UC pathogenesis, and in the response to different treatments, nothing is known about the role of microRNAs in GMA therapy in UC patients.
Methods
Seven consecutively UC patients who started GMA in combo therapy with infliximab were recruited. Peripheral blood samples were taken before the apheresis session, at the start of the induction (S0) and at the end (S10). They were follow-up during the induction phase (10 sessions: 2 sessions for a week during 3 wk and 1 session for a week during 4 wk) of the treatment at a tertiary hospital (Hospital la Fe) and 6 mo after finishing the GMA induction therapy. MiRNA was extracted and analyzed by RT-PCR. R software and GraphPad were used.
Results
Clinical disease activity significantly decreased after induction therapy with GMA (median partial Mayo score 2 (IQR, 1-6) (P < .05). Fecal calprotectin value and CRP value significantly decreased after induction therapy. Five microRNAs modified their expression during GMA (unsupervised analysis): miR-342-3p, miR-215-5p, miR-376c-3p, miR-139-5p, and miR-150-5p. When a sub-analysis was performed in those patients who showed good response to apheresis treatment (n = 5), two microRNAs showed to be implicated: miR-215-5p and miR-365a-3p. These are preliminary but promising and novel results, as it is the first time, to our knowledge that microRNA profiles have been studied in the context of GMA treatment for IBD.
{"title":"MicroRNA and granulocyte-monocyte adsorption apheresis combotherapy after inadequate response to anti-TNF agents in ulcerative colitis","authors":"Esteban Sáez-González MD, Inés Moret-Tatay PhD, Guillermo Bastida MD, PhD, Mariam Aguas MD, PhD, Marisa Iborra MD, PhD, Pilar Nos MD, PhD, Belén Beltrán MD, PhD","doi":"10.1002/jca.22101","DOIUrl":"10.1002/jca.22101","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Ulcerative colitis (UC) is an inflammatory bowel disease characterized by chronic inflammation of the gastrointestinal tract, affecting millions of individuals throughout the world, and producing an impaired health-related quality of life. Granulocyte and monocyte apheresis (GMA) is a therapeutic option for UC management to induce remission by selective removal of activated leukocytes from bloodstream. Despite the knowledge of the important role of epigenetics in UC pathogenesis, and in the response to different treatments, nothing is known about the role of microRNAs in GMA therapy in UC patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Seven consecutively UC patients who started GMA in combo therapy with infliximab were recruited. Peripheral blood samples were taken before the apheresis session, at the start of the induction (S0) and at the end (S10). They were follow-up during the induction phase (10 sessions: 2 sessions for a week during 3 wk and 1 session for a week during 4 wk) of the treatment at a tertiary hospital (Hospital la Fe) and 6 mo after finishing the GMA induction therapy. MiRNA was extracted and analyzed by RT-PCR. R software and GraphPad were used.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Clinical disease activity significantly decreased after induction therapy with GMA (median partial Mayo score 2 (IQR, 1-6) (<i>P</i> < .05). Fecal calprotectin value and CRP value significantly decreased after induction therapy. Five microRNAs modified their expression during GMA (unsupervised analysis): miR-342-3p, miR-215-5p, miR-376c-3p, miR-139-5p, and miR-150-5p. When a sub-analysis was performed in those patients who showed good response to apheresis treatment (<i>n</i> = 5), two microRNAs showed to be implicated: miR-215-5p and miR-365a-3p. These are preliminary but promising and novel results, as it is the first time, to our knowledge that microRNA profiles have been studied in the context of GMA treatment for IBD.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138487640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joseph Maakaron, Katie Picotte, Kevin Tram, Ruth Bakken, Jason Oakes, Meghann Cody, John Miller, Steven M. Devine, Heather E. Stefanski
<p>The Coronavirus Disease 2019 (COVID-19) pandemic in early 2020 resulted in multiple challenges for the NMDP. At the time, the Investigational New Drug (IND) protocol for peripheral blood stem cell (PBSC) mobilization was limited to the use of Neupogen (NP) (Amgen, CA), which created logistical problems on the supply side as it was difficult to rely on only one medication for mobilization. In fact, there were times when NP was unable to be secured for donors and this put undue stress on the operations teams and required IND exemptions. We realized early on in 2021 that allowing filgrastim biosimilars as mobilization agents would eliminate these issues without compromising donor safety. Moreover, the World Marrow Donor Association (WMDA) had recommended that Donor Registries could use filgrastim biosimilars for PBSC mobilization initially in 2017 and then a publication in 2019.<span><sup>1</sup></span> Thus, in February of 2022, the IND for PBSC mobilization was amended to allow all filgrastim biosimilars, including filgrastim-aafi (Nivestym, NV), filgrastim-sndz (Zarxio) and the recombinant human granulocyte-stimulating factor (G-CSF) TBO-filgrastim (Granix) as, well as the original NP. In March of 2022, NV was the preferred PBSC mobilization agent instead of NP for stem cell mobilization for all NMDP donors. We herein present a comparative analysis of the two drugs.</p><p>The NMDP routinely collects data about donors and grafts under an IRB approved protocol. In February of 2022, most donors received NV for stem cell mobilization due to availability and cost. The primary objectives were to compare donor safety, efficacy, and adverse events between March and July of 2021 where donors received NP and March-July 2022 where donors received NV. Of note, donors who received other biosimilars or similars after February 2022 were excluded from this study. Donor toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). All statistical analyses were performed using R statistical software version 4.2.0 (Boston, MA). Either 2 sample <i>t</i>-test or 2 sample test for proportions were used for 2 group comparisons, depending on whether the end point was an average or proportion. A <i>P</i> < .05 was considered statistically significant. Average dose values used a 95% trimmed mean to avoid skew from outliers.</p><p>There were 801 and 913 healthy donors who underwent stem cell mobilization with NP and NV, respectively. The main outcomes are summarized in Table 1. Average donor weight was similar between the groups (85 kg for NP vs 83 kg for NV). Day +5 pre-apheresis peripheral blood CD34 count and percentage did not differ between groups (95.4 cells/μL for NP vs 96.0 cells/μL for NV, <i>P</i> = .56; 0.22% vs 0.22%, <i>P</i> = .73). Median liters of blood processed was similar (16.2 for NP vs 15.8 for NV; <i>P</i> = .92) as was the requirement for a 2-day collection (5.0% for NP vs 5.4% for NV
{"title":"Validation of Nivestym compared to Neupogen: An NMDP analysis","authors":"Joseph Maakaron, Katie Picotte, Kevin Tram, Ruth Bakken, Jason Oakes, Meghann Cody, John Miller, Steven M. Devine, Heather E. Stefanski","doi":"10.1002/jca.22097","DOIUrl":"10.1002/jca.22097","url":null,"abstract":"<p>The Coronavirus Disease 2019 (COVID-19) pandemic in early 2020 resulted in multiple challenges for the NMDP. At the time, the Investigational New Drug (IND) protocol for peripheral blood stem cell (PBSC) mobilization was limited to the use of Neupogen (NP) (Amgen, CA), which created logistical problems on the supply side as it was difficult to rely on only one medication for mobilization. In fact, there were times when NP was unable to be secured for donors and this put undue stress on the operations teams and required IND exemptions. We realized early on in 2021 that allowing filgrastim biosimilars as mobilization agents would eliminate these issues without compromising donor safety. Moreover, the World Marrow Donor Association (WMDA) had recommended that Donor Registries could use filgrastim biosimilars for PBSC mobilization initially in 2017 and then a publication in 2019.<span><sup>1</sup></span> Thus, in February of 2022, the IND for PBSC mobilization was amended to allow all filgrastim biosimilars, including filgrastim-aafi (Nivestym, NV), filgrastim-sndz (Zarxio) and the recombinant human granulocyte-stimulating factor (G-CSF) TBO-filgrastim (Granix) as, well as the original NP. In March of 2022, NV was the preferred PBSC mobilization agent instead of NP for stem cell mobilization for all NMDP donors. We herein present a comparative analysis of the two drugs.</p><p>The NMDP routinely collects data about donors and grafts under an IRB approved protocol. In February of 2022, most donors received NV for stem cell mobilization due to availability and cost. The primary objectives were to compare donor safety, efficacy, and adverse events between March and July of 2021 where donors received NP and March-July 2022 where donors received NV. Of note, donors who received other biosimilars or similars after February 2022 were excluded from this study. Donor toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). All statistical analyses were performed using R statistical software version 4.2.0 (Boston, MA). Either 2 sample <i>t</i>-test or 2 sample test for proportions were used for 2 group comparisons, depending on whether the end point was an average or proportion. A <i>P</i> < .05 was considered statistically significant. Average dose values used a 95% trimmed mean to avoid skew from outliers.</p><p>There were 801 and 913 healthy donors who underwent stem cell mobilization with NP and NV, respectively. The main outcomes are summarized in Table 1. Average donor weight was similar between the groups (85 kg for NP vs 83 kg for NV). Day +5 pre-apheresis peripheral blood CD34 count and percentage did not differ between groups (95.4 cells/μL for NP vs 96.0 cells/μL for NV, <i>P</i> = .56; 0.22% vs 0.22%, <i>P</i> = .73). Median liters of blood processed was similar (16.2 for NP vs 15.8 for NV; <i>P</i> = .92) as was the requirement for a 2-day collection (5.0% for NP vs 5.4% for NV","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22097","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138460169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ryan D. Salazar, Krystol R. Weidner, Caroline R. Alquist
Susac's syndrome (SuS) is an autoimmune endotheliopathy that typically presents with the clinical triad of encephalopathy, hearing loss, and branch retinal artery occlusion. It has a wide range of possible presentations, and its pathogenesis remains uncertain. Fulminant and refractory cases are difficult to treat, and no standard treatment protocol has been established. However, therapeutic plasma exchange (TPE) has been described as an adjunctive therapy in several SuS cases. Herein we present a case of a 63-year-old male with debilitating encephalopathy and recent hearing and vision loss, who responded favorably to TPE. Given this and other published reports of plasma exchange therapy for SuS, treatment protocols should consider TPE in early stages of disease.
{"title":"Therapeutic plasma exchange in refractory Susac's syndrome: A brief report","authors":"Ryan D. Salazar, Krystol R. Weidner, Caroline R. Alquist","doi":"10.1002/jca.22098","DOIUrl":"10.1002/jca.22098","url":null,"abstract":"<p>Susac's syndrome (SuS) is an autoimmune endotheliopathy that typically presents with the clinical triad of encephalopathy, hearing loss, and branch retinal artery occlusion. It has a wide range of possible presentations, and its pathogenesis remains uncertain. Fulminant and refractory cases are difficult to treat, and no standard treatment protocol has been established. However, therapeutic plasma exchange (TPE) has been described as an adjunctive therapy in several SuS cases. Herein we present a case of a 63-year-old male with debilitating encephalopathy and recent hearing and vision loss, who responded favorably to TPE. Given this and other published reports of plasma exchange therapy for SuS, treatment protocols should consider TPE in early stages of disease.</p>","PeriodicalId":15390,"journal":{"name":"Journal of Clinical Apheresis","volume":"39 1","pages":""},"PeriodicalIF":1.5,"publicationDate":"2023-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jca.22098","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138291081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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