Cardiac surgery with cardiopulmonary bypass (CPB) requires precise hemostasis management to limit postoperative bleeding. Fibrinogen, platelet count, and pro-coagulant factors guide transfusion decisions, yet Clauss fibrinogen measurement during CPB is debated, and prothrombin time (PT) cannot be measured accurately due to interference from high-dose heparin. This study investigated whether intraoperative measurements of fibrinogen, prothrombin (FII), factor V (FV), and platelet obtained during CPB could reliably predict post-CPB values.
Methods
We conducted a single-center, prospective observational study involving 73 adult patients undergoing cardiac surgery with CPB. Blood samples were collected before aortic unclamping and five minutes after completion of protamine administration. Fibrinogen (Clauss method), FII, and FV activities were measured using HemosIL reagents on an ACL TOP analyzer.
Results
Using appropriate reagents, fibrinogen, FII, and FV were reliably measured during CPB, despite high-dose heparin. Strong correlations were observed between intra-CPB and post-CPB values for fibrinogen (r = 0.81), FII (r = 0.78), and FV (r = 0.73), supporting their reliability in anticipating post-bypass coagulation status. ROC curve analyses demonstrated good predictive performance for transfusion-relevant thresholds, with AUCs of 0.93 for platelet count <100 G/L, 0.86 for fibrinogen <1.5 g/L, and 0.84 for FII < 50% activity.
Conclusions
This study showed that fibrinogen and factor II (a surrogate for PT) levels remain consistent between the CPB period and after protamine administration in adult cardiac surgery patients, confirming the reliability of their intraoperative assessment.
{"title":"Standard coagulation assays during cardiopulmonary bypass predict post-bypass levels in cardiac surgery","authors":"Victor-Emmanuel Brett , Antoine Beurton , Alexandre Ouattara , Céline Delassasseigne , Christine Mouton","doi":"10.1016/j.thromres.2026.109593","DOIUrl":"10.1016/j.thromres.2026.109593","url":null,"abstract":"<div><h3>Background</h3><div>Cardiac surgery with cardiopulmonary bypass (CPB) requires precise hemostasis management to limit postoperative bleeding. Fibrinogen, platelet count, and pro-coagulant factors guide transfusion decisions, yet Clauss fibrinogen measurement during CPB is debated, and prothrombin time (PT) cannot be measured accurately due to interference from high-dose heparin. This study investigated whether intraoperative measurements of fibrinogen, prothrombin (FII), factor V (FV), and platelet obtained during CPB could reliably predict post-CPB values.</div></div><div><h3>Methods</h3><div>We conducted a single-center, prospective observational study involving 73 adult patients undergoing cardiac surgery with CPB. Blood samples were collected before aortic unclamping and five minutes after completion of protamine administration. Fibrinogen (Clauss method), FII, and FV activities were measured using HemosIL reagents on an ACL TOP analyzer.</div></div><div><h3>Results</h3><div>Using appropriate reagents, fibrinogen, FII, and FV were reliably measured during CPB, despite high-dose heparin. Strong correlations were observed between intra-CPB and post-CPB values for fibrinogen (<em>r</em> = 0.81), FII (<em>r</em> = 0.78), and FV (<em>r</em> = 0.73), supporting their reliability in anticipating post-bypass coagulation status. ROC curve analyses demonstrated good predictive performance for transfusion-relevant thresholds, with AUCs of 0.93 for platelet count <100 G/L, 0.86 for fibrinogen <1.5 g/L, and 0.84 for FII < 50% activity.</div></div><div><h3>Conclusions</h3><div>This study showed that fibrinogen and factor II (a surrogate for PT) levels remain consistent between the CPB period and after protamine administration in adult cardiac surgery patients, confirming the reliability of their intraoperative assessment.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109593"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146030793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-22DOI: 10.1016/j.thromres.2025.109570
Robert D. McBane II , Jennifer Lutz , Carlee O'Connor , Anna Kramer , Michael Luker , David Hodge , Colleen S. Thomas , Harold J. Hellweg
Objective
Systems employing point-of-care (POC) INR monitoring with patient self-testing require test accuracy, data integrity, patient compliance, and prompt two-way communication for high quality warfarin management. With a goal of validating a POC Bluetooth capable device for prompt INR transfer to electronic medical record, two POC INR devices were compared against an internal plasma INR reference.
Methods
A multicenter study (February 14, 2023 – August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.
Results
Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0–3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R2 = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus – plasma INR correlation R2 = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (p < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.
Conclusions
Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.
{"title":"Bluetooth enabled point-of-care INR device validation for warfarin management","authors":"Robert D. McBane II , Jennifer Lutz , Carlee O'Connor , Anna Kramer , Michael Luker , David Hodge , Colleen S. Thomas , Harold J. Hellweg","doi":"10.1016/j.thromres.2025.109570","DOIUrl":"10.1016/j.thromres.2025.109570","url":null,"abstract":"<div><h3>Objective</h3><div>Systems employing point-of-care (POC) INR monitoring with patient self-testing require test accuracy, data integrity, patient compliance, and prompt two-way communication for high quality warfarin management. With a goal of validating a POC Bluetooth capable device for prompt INR transfer to electronic medical record, two POC INR devices were compared against an internal plasma INR reference.</div></div><div><h3>Methods</h3><div>A multicenter study (February 14, 2023 – August 29, 2023) comparing concordance of two commercially available POC devices, Vantus and CoaguChek XS (Pro and Plus), against a plasma INR reference, was pursued among warfarin treated patients. Appropriateness of dosing decisions were assessed for each device.</div></div><div><h3>Results</h3><div>Across three Mayo Clinic sites, 151 warfarin treated patients agreed to participate. Atrial fibrillation (41.7 %), venous thromboembolism (33.1 %) and heart valve prosthesis (19.9 %) were common indications with target INR range 2.0–3.0 in 89 %. For the CoaguChek devices, 86.1 % of values fell within 0.4 INR units compared with plasma INR referent (CoaguChek - plasma INR correlation R<sup>2</sup> = 0.95). For the Vantus device, 88.7 % of values fell within 0.4 INR units of plasma INR values (Vantus – plasma INR correlation R<sup>2</sup> = 0.96). Mean (± standard deviation) deviation from plasma INR was 0.2 ± 0.3 for CoaguChek compared to 0.1 ± 0.2 for Vantus (<em>p</em> < 0.001). Using the plasma INR as the gold standard for dosing recommendations, appropriate dosing recommendations were similar between devices: CoaguChek 83.4 % vs Vantus 82.7 %.</div></div><div><h3>Conclusions</h3><div>Compared to a plasma referent, INR values obtained from the CoaguChek and Vantus devices exhibited strong correlation with plasma INR values without systemic bias.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109570"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145864826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-08DOI: 10.1016/j.thromres.2026.109582
Joanna Natorska , Magdalena Kopytek , Aleksandra Gołąb , Anna Waśniowska , Małgorzata Konieczyńska , Anetta Undas , Michał Ząbczyk
Background
Thromboelastography (TEG) is used in various clinical settings to assess clot formation, strength, and lysis. It is unknown whether TEG measures correspond to plasma fibrin clot characteristics.
Methods
In 90 individuals free of cardiovascular disease (51 [56.7%] women, aged 49.3 ± 5.2 years, body-mass index [BMI], 26 [23.8–29.3] kg/m2) we assessed whole blood clot parameters (reaction [R] and clot formation [K] time, clot growth kinetics [angle], maximum amplitude [MA], and clot lysis [LY30]) using the TEG 6s analyzer (Haemonetics, Boston, US), plasma clot permeability (Ks), and clot lysis time (CLT) using three assays: (1) by Pieters (CLT-2018), (2) by Lisman (CLT), and (3) by Carter (Lys50).
Results
There were associations of Ks with K time (R = 0.29, p = 0.0053), angle (R = -0.31, p = 0.0033), and MA (R = −0.47, p < 0.0001), while CLT tended to correlate with LY30. In women compared to men Ks was 8.4% lower corresponding to 7% higher MA (both p < 0.001). In obese (n = 19, 21.1%) vs. non-obese individuals angle was 5% larger (p = 0.029) but BMI did not correlate with TEG measures. TEG parameters and fibrin clot properties were unaffected by smoking, hypertension or hyperlipidemia. More efficient fibrinolysis (LY30 > 2.6%) was detected in 15 (16.7%) individuals who had also shorter CLT-2018 and CLT (both p < 0.05). Hypofibrinolysis (CLT-2018 > 300 min; n = 8, 8.9%) was detected only using CLT with no differences in TEG indices or Lys50.
Conclusions
TEG and plasma fibrin clot properties are complementary methods for assessing hemostasis, however, fibrin clot properties better reflect the impact of clinical risk factors on fibrinogen modification.
{"title":"Comparative analysis of whole blood clot viscoelastic properties via thromboelastography and plasma fibrin clot characteristics","authors":"Joanna Natorska , Magdalena Kopytek , Aleksandra Gołąb , Anna Waśniowska , Małgorzata Konieczyńska , Anetta Undas , Michał Ząbczyk","doi":"10.1016/j.thromres.2026.109582","DOIUrl":"10.1016/j.thromres.2026.109582","url":null,"abstract":"<div><h3>Background</h3><div>Thromboelastography (TEG) is used in various clinical settings to assess clot formation, strength, and lysis. It is unknown whether TEG measures correspond to plasma fibrin clot characteristics.</div></div><div><h3>Methods</h3><div>In 90 individuals free of cardiovascular disease (51 [56.7%] women, aged 49.3 ± 5.2 years, body-mass index [BMI], 26 [23.8–29.3] kg/m<sup>2</sup>) we assessed whole blood clot parameters (reaction [R] and clot formation [K] time, clot growth kinetics [angle], maximum amplitude [MA], and clot lysis [LY30]) using the TEG 6s analyzer (Haemonetics, Boston, US), plasma clot permeability (Ks), and clot lysis time (CLT) using three assays: (1) by Pieters (CLT-2018), (2) by Lisman (CLT), and (3) by Carter (Lys50).</div></div><div><h3>Results</h3><div>There were associations of Ks with K time (<em>R</em> = 0.29, <em>p</em> = 0.0053), angle (R = -0.31, <em>p</em> = 0.0033), and MA (<em>R</em> = −0.47, <em>p</em> < 0.0001), while CLT tended to correlate with LY30. In women compared to men Ks was 8.4% lower corresponding to 7% higher MA (both <em>p</em> < 0.001). In obese (<em>n</em> = 19, 21.1%) vs. non-obese individuals angle was 5% larger (<em>p</em> = 0.029) but BMI did not correlate with TEG measures. TEG parameters and fibrin clot properties were unaffected by smoking, hypertension or hyperlipidemia. More efficient fibrinolysis (LY30 > 2.6%) was detected in 15 (16.7%) individuals who had also shorter CLT-2018 and CLT (both <em>p</em> < 0.05). Hypofibrinolysis (CLT-2018 > 300 min; <em>n</em> = 8, 8.9%) was detected only using CLT with no differences in TEG indices or Lys50.</div></div><div><h3>Conclusions</h3><div>TEG and plasma fibrin clot properties are complementary methods for assessing hemostasis, however, fibrin clot properties better reflect the impact of clinical risk factors on fibrinogen modification.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109582"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145979149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-06DOI: 10.1016/j.thromres.2025.109580
Maria Chovi-Trull , Juan Eduardo Megías-Vericat , Tomás Palanques-Pastor , Ana Cid Haro , Manuel Rodriguez López , Antonio Palomero Massanet , Shally Marcellini Antonio , Saturnino Haya Guaita , Javier García Pellicer , Jose Luis Poveda Andrés , Santiago Bonanad Boix
Introduction
Extended half-life factor IX concentrates (FIX-EHL) have been shown to improve clinical outcomes and reduce treatment burden in patients with hemophilia B (HB).
Objectives
To analyze the differences in pharmacokinetic (PK) and clinical parameters one year before and after the PK-guided switch from standard half-life FIX (FIX-SHL) to FIX-EHL in patients with severe/moderate HB on prophylaxis.
Methods
A multicenter, comparative, observational, sequential, retrospective, and multidisciplinary study was conducted. PK parameters were calculated with WAPPS-Hemo®, and annualized total (ABR) and joint bleeding rates, the t1/2 ratio and area under the curve (AUC), FIX consumption, infusion frequency, and cost were recorded.
Results
A total of 21 patients (9 pediatric and 12 adult) with HB who switched from FIX-SHL to FIX-EHL were analyzed. All PK parameters improved significantly, with median improvement ratios for t1/2 and AUC of 4.1 (IQR: 3.4–4.8) and 4.2 (IQR: 2.6–5.0), respectively. Regarding clinical outcomes, the difference in ABR reached statistical significance and among the 6 patients with target joints, 5 (83.3 %) achieved resolution after switching. Infusion frequency and weekly dose were reduced by 50.0 % and 56.3 %, respectively, avoiding 52.1 (IQR: 26.1–67.8) injections and 130,357.3 (IQR: 5142.9–203,357.3) IU of FIX per patient per year. However, the switch resulted in an additional cost of € 28,254.9 (IQR: 4432.1- 44,060.8) per patient per year.
Conclusions
The PK-guided switch from FIX-SHL to FIX-EHL was associated with improvements in all PK parameters, and a significant clinical benefit was also demonstrated with the reduction of the bleeding rates. Following the switch, the weekly dose and administration frequency were reduced; however, this did not result in a cost reduction.
{"title":"Improvements in pharmacokinetics, bleeding control, and cost analysis after PK-guided transition to extended-half-life factor IX in hemophilia B: A multicentric study","authors":"Maria Chovi-Trull , Juan Eduardo Megías-Vericat , Tomás Palanques-Pastor , Ana Cid Haro , Manuel Rodriguez López , Antonio Palomero Massanet , Shally Marcellini Antonio , Saturnino Haya Guaita , Javier García Pellicer , Jose Luis Poveda Andrés , Santiago Bonanad Boix","doi":"10.1016/j.thromres.2025.109580","DOIUrl":"10.1016/j.thromres.2025.109580","url":null,"abstract":"<div><h3>Introduction</h3><div>Extended half-life factor IX concentrates (FIX-EHL) have been shown to improve clinical outcomes and reduce treatment burden in patients with hemophilia B (HB).</div></div><div><h3>Objectives</h3><div>To analyze the differences in pharmacokinetic (PK) and clinical parameters one year before and after the PK-guided switch from standard half-life FIX (FIX-SHL) to FIX-EHL in patients with severe/moderate HB on prophylaxis.</div></div><div><h3>Methods</h3><div>A multicenter, comparative, observational, sequential, retrospective, and multidisciplinary study was conducted. PK parameters were calculated with WAPPS-Hemo®, and annualized total (ABR) and joint bleeding rates, the t<sub>1/2</sub> ratio and area under the curve (AUC), FIX consumption, infusion frequency, and cost were recorded.</div></div><div><h3>Results</h3><div>A total of 21 patients (9 pediatric and 12 adult) with HB who switched from FIX-SHL to FIX-EHL were analyzed. All PK parameters improved significantly, with median improvement ratios for t<sub>1/2</sub> and AUC of 4.1 (IQR: 3.4–4.8) and 4.2 (IQR: 2.6–5.0), respectively. Regarding clinical outcomes, the difference in ABR reached statistical significance and among the 6 patients with target joints, 5 (83.3 %) achieved resolution after switching. Infusion frequency and weekly dose were reduced by 50.0 % and 56.3 %, respectively, avoiding 52.1 (IQR: 26.1–67.8) injections and 130,357.3 (IQR: 5142.9–203,357.3) IU of FIX per patient per year. However, the switch resulted in an additional cost of € 28,254.9 (IQR: 4432.1- 44,060.8) per patient per year.</div></div><div><h3>Conclusions</h3><div>The PK-guided switch from FIX-SHL to FIX-EHL was associated with improvements in all PK parameters, and a significant clinical benefit was also demonstrated with the reduction of the bleeding rates. Following the switch, the weekly dose and administration frequency were reduced; however, this did not result in a cost reduction.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109580"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145967192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-10DOI: 10.1016/j.thromres.2026.109584
Fengting Yuan , Huan Zhang , Dong Zhang , Xiong Zhao , Qiang Wang , Junting Jia , Rui Wang , Zhenpeng Fu , Linsheng Zhan , Jingang Zhang , Fang Yuan , Yuyuan Ma
Internal hemorrhage remains a critical challenge requiring immediate intervention. Recent advances in biomaterials have positioned fibrin hemostatic patches (FHPs) as a promising therapeutic option through targeted fibrinogen-to-fibrin conversion at the injured organ; however, insufficient understanding of the stoichiometric coupling between active components of FHP may limit its coagulation performance. Here, we report a novel FHP (nFHP) through orthogonal optimization of fibrinogen, thrombin, and calcium chloride. Systematic screening identified fibrinogen concentration as the primary determinant of clotting time, with fibrinogen-to-thrombin and fibrinogen-to-calcium chloride ratios further impacting. nFHP, fabricated with the optimal formulation (17 mg/cm2 fibrinogen, 40 IU/cm2 thrombin, 115 μg/cm2 calcium chloride), achieved rapid fibrin network formation and superior adhesive strength on the porcine aorta, surpassing commercial FHP (cFHP). In vivo evaluations across hepatic resection, cardiac stab wound, and arterial hemorrhage models demonstrated nFHP's universal efficacy, achieving the minimal blood loss compared to commercial products. Our work identifies stoichiometric proportion as a key factor in fibrin-based biomaterial rational design and provides a translatable solution for uncontrolled internal hemorrhage.
{"title":"Enhanced efficacy of fibrin hemostatic patch through rational design at the molecular level","authors":"Fengting Yuan , Huan Zhang , Dong Zhang , Xiong Zhao , Qiang Wang , Junting Jia , Rui Wang , Zhenpeng Fu , Linsheng Zhan , Jingang Zhang , Fang Yuan , Yuyuan Ma","doi":"10.1016/j.thromres.2026.109584","DOIUrl":"10.1016/j.thromres.2026.109584","url":null,"abstract":"<div><div>Internal hemorrhage remains a critical challenge requiring immediate intervention. Recent advances in biomaterials have positioned fibrin hemostatic patches (FHPs) as a promising therapeutic option through targeted fibrinogen-to-fibrin conversion at the injured organ; however, insufficient understanding of the stoichiometric coupling between active components of FHP may limit its coagulation performance. Here, we report a novel FHP (nFHP) through orthogonal optimization of fibrinogen, thrombin, and calcium chloride. Systematic screening identified fibrinogen concentration as the primary determinant of clotting time, with fibrinogen-to-thrombin and fibrinogen-to-calcium chloride ratios further impacting. nFHP, fabricated with the optimal formulation (17 mg/cm<sup>2</sup> fibrinogen, 40 IU/cm<sup>2</sup> thrombin, 115 μg/cm<sup>2</sup> calcium chloride), achieved rapid fibrin network formation and superior adhesive strength on the porcine aorta, surpassing commercial FHP (cFHP). In vivo evaluations across hepatic resection, cardiac stab wound, and arterial hemorrhage models demonstrated nFHP's universal efficacy, achieving the minimal blood loss compared to commercial products. Our work identifies stoichiometric proportion as a key factor in fibrin-based biomaterial rational design and provides a translatable solution for uncontrolled internal hemorrhage.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109584"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-12DOI: 10.1016/j.thromres.2026.109585
Alexandra C. Frost , Veysel K. Baris , Michael Sainlaire , Jin Chen , Minakshi V. Shukla , Md Shifatul A. Apurba , Ann C. Hurley , Patricia C. Dykes
Introduction
Delayed diagnosis (DDx) of Venous thromboembolism (VTE) contributes to preventable mortality. Our prior work resulted in an electronic Clinical Quality Measure (eCQM) for Diagnostic Delay of VTE (DOVE) [1] and a phenotyping algorithm to identify cases of VTE [2]. Current work incorporates voices of VTE survivors to extend that research.
Methods
We interviewed 8 and surveyed 68 VTE survivors, coded and categorized text, and uploaded data into the DOVE qualitative database. Drawing on this database and patient self-management literature, notably the concepts: patient engagement [3,4] and patient activation [5,6] we developed a model to guide “Successful Living with VTE.”
Results
The 76 VTE survivors provided rich descriptions of their journeys from questioning that something may be wrong to making recommendations to help others. Participants were articulate, highly educated, mostly female and white, and geographically diverse. Recommendations were defined as “Recommendations for patients, providers and health care sites targeted to achieve timely VTE diagnosis and treatment across the trajectory from first concern through follow-up care.” Patients are advised to be assertive, obtain education and bring a support person. Providers are advised to listen, be knowledgeable and consider genetic testing.
Conclusions
The recommendations make common sense, do not require expensive equipment or intensive training or extra staff. VTE survivors' recommendations merged with the science of patient self-management provided the model's structure. The model will inform a VTE curriculum and clinical decision support application, and guide research to promote successful living with VTE.
{"title":"A model to guide successful living with venous thromboembolism (VTE): Recommendations derived from the qualitative phase of a study of diagnostic Delay of VTE (DOVE)","authors":"Alexandra C. Frost , Veysel K. Baris , Michael Sainlaire , Jin Chen , Minakshi V. Shukla , Md Shifatul A. Apurba , Ann C. Hurley , Patricia C. Dykes","doi":"10.1016/j.thromres.2026.109585","DOIUrl":"10.1016/j.thromres.2026.109585","url":null,"abstract":"<div><h3>Introduction</h3><div><u>D</u>elayed <u>d</u>iagnosis (DDx) of <u>V</u>enous <u>t</u>hrombo<u>e</u>mbolism (VTE) contributes to preventable mortality. Our prior work resulted in an electronic Clinical Quality Measure (eCQM) for Diagnostic <u>D</u>elay <u>o</u>f <u>V</u>T<u>E</u> (DOVE) [1] and a phenotyping algorithm to identify cases of VTE [2]. Current work incorporates voices of VTE survivors to extend that research.</div></div><div><h3>Methods</h3><div>We interviewed 8 and surveyed 68 VTE survivors, coded and categorized text, and uploaded data into the DOVE qualitative database. Drawing on this database and patient self-management literature, notably the concepts: patient engagement [3,4] and patient activation [5,6] we developed a model to guide “Successful Living with VTE.”</div></div><div><h3>Results</h3><div>The 76 VTE survivors provided rich descriptions of their journeys from questioning that something may be wrong to making recommendations to help others. Participants were articulate, highly educated, mostly female and white, and geographically diverse. Recommendations were defined as “Recommendations for patients, providers and health care sites targeted to achieve timely VTE diagnosis and treatment across the trajectory from first concern through follow-up care.” Patients are advised to <u>be assertive</u>, <u>obtain education</u> and <u>bring a support person</u>. Providers are advised to l<u>isten</u>, <u>be knowledgeable</u> and <u>consider genetic testing</u>.</div></div><div><h3>Conclusions</h3><div>The recommendations make common sense, do not require expensive equipment or intensive training or extra staff. VTE survivors' recommendations merged with the science of patient self-management provided the model's structure. The model will inform a VTE curriculum and clinical decision support application, and guide research to promote successful living with VTE.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109585"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977995","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The clinical utility of routine thrombophilia testing to guide management in pediatric venous thromboembolism (VTE) is debated. This study sought to evaluate the real-world impact of thrombophilia testing on anticoagulation duration and clinical outcomes.
Methods
We conducted a 10-year retrospective cohort study of 67 pediatric patients with VTE. We analyzed the association between thrombophilia status and anticoagulation duration, VTE recurrence, and thrombus resolution on follow-up imaging.
Results
The majority of VTE events (80.6 %) were provoked. A positive thrombophilia workup did not significantly alter the median anticoagulation duration compared to a negative workup (p = 0.582). A positive thrombophilia status was not a significant predictor of VTE recurrence in survival analysis (HR 2.22, p = 0.281). However, a positive workup was significantly associated with a higher rate of Residual Vein Obstruction (RVO) (73.3 % vs. 36.4 %, p = 0.045). This imaging finding did not, in turn, predict VTE recurrence (p = 0.388).
Conclusion
Thrombophilia testing did not influence treatment duration or predict recurrence. Our findings provide real-world evidence supporting current guidelines that advocate for a selective, clinically driven approach to testing rather than its routine use after a first pediatric VTE.
{"title":"Rethinking thrombophilia testing in pediatric VTE: A decade of real-world evidence","authors":"Mahdi Asleh , Hadeel Musa , Shirly Ammar , Hagit Miskin","doi":"10.1016/j.thromres.2025.109565","DOIUrl":"10.1016/j.thromres.2025.109565","url":null,"abstract":"<div><h3>Background</h3><div>The clinical utility of routine thrombophilia testing to guide management in pediatric venous thromboembolism (VTE) is debated. This study sought to evaluate the real-world impact of thrombophilia testing on anticoagulation duration and clinical outcomes.</div></div><div><h3>Methods</h3><div>We conducted a 10-year retrospective cohort study of 67 pediatric patients with VTE. We analyzed the association between thrombophilia status and anticoagulation duration, VTE recurrence, and thrombus resolution on follow-up imaging.</div></div><div><h3>Results</h3><div>The majority of VTE events (80.6 %) were provoked. A positive thrombophilia workup did not significantly alter the median anticoagulation duration compared to a negative workup (<em>p</em> = 0.582). A positive thrombophilia status was not a significant predictor of VTE recurrence in survival analysis (HR 2.22, <em>p</em> = 0.281). However, a positive workup was significantly associated with a higher rate of Residual Vein Obstruction (RVO) (73.3 % vs. 36.4 %, <em>p</em> = 0.045). This imaging finding did not, in turn, predict VTE recurrence (<em>p</em> = 0.388).</div></div><div><h3>Conclusion</h3><div>Thrombophilia testing did not influence treatment duration or predict recurrence. Our findings provide real-world evidence supporting current guidelines that advocate for a selective, clinically driven approach to testing rather than its routine use after a first pediatric VTE.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"258 ","pages":"Article 109565"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145824217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-24DOI: 10.1016/j.thromres.2025.109554
Gianni Turcato , Arian Zaboli , Lucia Filippi , Paolo Ferretto , Alice Bresolin , Fabrizio Lucente , Alessandro Cipriano , Lorenzo Ghiadoni , Walter Ageno , Christian J. Wiedermann
Background
Sepsis-induced coagulopathy (SIC) is an early phase of disseminated intravascular coagulation and a candidate marker for risk stratification. Although SIC is linked to higher mortality, its value for predicting thrombotic and hemorrhagic events remains uncertain. We assessed the prevalence of SIC and its association with hemostatic complications and mortality in sepsis.
Methods
In a prospective cohort of 389 adults with sepsis admitted to an intermediate care unit, SIC was defined by International Society of Thrombosis and Haemostasis criteria (score ≥ 4). Primary outcomes were 30-day venous thromboembolism, arterial thrombosis, and bleeding; all-cause 30-day mortality was secondary. Predictive performance of the SIC score was evaluated with receiver operating characteristic analysis, bootstrap resampling, and Monte Carlo simulation.
Results
SIC was present in 33.4 % of patients. Thirty-day mortality was 27.1 % in SIC-positive patients versus 13.1 % in SIC-negative patients (p = 0.001), and SIC remained independently associated with death (adjusted OR 1.43; 95 % CI 1.13–1.80; p = 0.003). SIC positivity was not associated with overall thrombotic events: 42.9 % (12/28) of patients with thrombosis and 32.7 % (118/361) without thrombosis had SIC (p = 0.301). Discrimination for thrombotic and hemorrhagic events was poor (AUROC 0.573 and 0.576, respectively), with further decline after resampling; simulation analyses confirmed limited predictive capacity for either complication.
Conclusions
In this cohort, SIC was associated with higher mortality but not with thrombotic or hemorrhagic events. This association likely reflects overall severity of illness rather than clinically overt vascular complications. These findings do not support using SIC alone to guide anticoagulation or transfusion decisions and support the development of outcome-specific risk models, potentially integrating dynamic clinical variables and serial laboratory trajectories.
{"title":"Thrombosis, bleeding, and mortality in patients with sepsis-induced coagulopathy: Analysis of a prospective cohort","authors":"Gianni Turcato , Arian Zaboli , Lucia Filippi , Paolo Ferretto , Alice Bresolin , Fabrizio Lucente , Alessandro Cipriano , Lorenzo Ghiadoni , Walter Ageno , Christian J. Wiedermann","doi":"10.1016/j.thromres.2025.109554","DOIUrl":"10.1016/j.thromres.2025.109554","url":null,"abstract":"<div><h3>Background</h3><div>Sepsis-induced coagulopathy (SIC) is an early phase of disseminated intravascular coagulation and a candidate marker for risk stratification. Although SIC is linked to higher mortality, its value for predicting thrombotic and hemorrhagic events remains uncertain. We assessed the prevalence of SIC and its association with hemostatic complications and mortality in sepsis.</div></div><div><h3>Methods</h3><div>In a prospective cohort of 389 adults with sepsis admitted to an intermediate care unit, SIC was defined by International Society of Thrombosis and Haemostasis criteria (score ≥ 4). Primary outcomes were 30-day venous thromboembolism, arterial thrombosis, and bleeding; all-cause 30-day mortality was secondary. Predictive performance of the SIC score was evaluated with receiver operating characteristic analysis, bootstrap resampling, and Monte Carlo simulation.</div></div><div><h3>Results</h3><div>SIC was present in 33.4 % of patients. Thirty-day mortality was 27.1 % in SIC-positive patients versus 13.1 % in SIC-negative patients (<em>p</em> = 0.001), and SIC remained independently associated with death (adjusted OR 1.43; 95 % CI 1.13–1.80; <em>p</em> = 0.003). SIC positivity was not associated with overall thrombotic events: 42.9 % (12/28) of patients with thrombosis and 32.7 % (118/361) without thrombosis had SIC (<em>p</em> = 0.301). Discrimination for thrombotic and hemorrhagic events was poor (AUROC 0.573 and 0.576, respectively), with further decline after resampling; simulation analyses confirmed limited predictive capacity for either complication.</div></div><div><h3>Conclusions</h3><div>In this cohort, SIC was associated with higher mortality but not with thrombotic or hemorrhagic events. This association likely reflects overall severity of illness rather than clinically overt vascular complications. These findings do not support using SIC alone to guide anticoagulation or transfusion decisions and support the development of outcome-specific risk models, potentially integrating dynamic clinical variables and serial laboratory trajectories.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109554"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145606239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01Epub Date: 2025-11-26DOI: 10.1016/j.thromres.2025.109557
Emily Fritzmann , Alexander D. Yuen , Stephanie Chang , Maidah Yaqoob , April Kinninger , Jina Chung , Janine R.E. Vintch , Yuri Matusov
Right heart thrombi (RHT) are a rare entity with high morbidity and mortality. There are no societal guidelines on the management of intracardiac thrombi. In an effort to understand the clinical elements associated with treatment decisions for RHT, this retrospective multi-center cohort study evaluated a real-world diverse patient population treated at two academic medical centers with PE response team (PERT) programs who presented with RHT, with and without PE, and evaluated the associated treatment strategies and outcomes. This study examined the clinical features and outcomes among patients presenting with RHT who were treated with anticoagulation monotherapy, systemic thrombolysis, and advanced intervention. Outcomes of interest included 30-day mortality, duration of hospitalization, need for ICU admission, bleeding complications, and in-hospital mortality. A total of 48 adult patients with RHT identified by transthoracic echocardiography (TTE) between January 2010 and December 2022 were included. Most patients with RHT presented with intermediate-high or high risk PE with right heart dysfunction. Mortality at 30 days was higher in the anticoagulation monotherapy group when compared to the systemic thrombolysis and advanced intervention groups, though not reaching statistical significance (25 % vs 11 % and 5.6 %, respectively). Other outcomes were not significantly different between groups. Although it is not clear that advanced therapy offers a benefit in this population overall, there are likely patients who will benefit; identifying that subpopulation remains a key question.
右心血栓(RHT)是一种发病率和死亡率都很高的罕见疾病。目前还没有关于心脏内血栓处理的社会指南。为了了解与RHT治疗决策相关的临床因素,这项回顾性多中心队列研究评估了在两个学术医疗中心接受PE反应小组(PERT)项目治疗的真实世界不同患者群体,这些患者接受RHT治疗,伴有和不伴有PE,并评估了相关的治疗策略和结果。本研究考察了接受抗凝单药治疗、全身溶栓和晚期干预治疗的RHT患者的临床特征和预后。关注的结局包括30天死亡率、住院时间、ICU入院需求、出血并发症和住院死亡率。本研究纳入2010年1月至2022年12月通过经胸超声心动图(TTE)确诊的48例成年RHT患者。大多数RHT患者表现为中高或高风险PE伴右心功能障碍。与全身性溶栓和高级干预组相比,抗凝单药组30天死亡率更高,但未达到统计学意义(分别为25% vs 11%和5.6%)。其他结果组间无显著差异。虽然尚不清楚先进的治疗是否对这一人群整体有益,但可能会有患者从中受益;确定这个亚群仍然是一个关键问题。
{"title":"Clinical features, management, and outcomes of right heart thrombi: a retrospective cohort study","authors":"Emily Fritzmann , Alexander D. Yuen , Stephanie Chang , Maidah Yaqoob , April Kinninger , Jina Chung , Janine R.E. Vintch , Yuri Matusov","doi":"10.1016/j.thromres.2025.109557","DOIUrl":"10.1016/j.thromres.2025.109557","url":null,"abstract":"<div><div>Right heart thrombi (RHT) are a rare entity with high morbidity and mortality. There are no societal guidelines on the management of intracardiac thrombi. In an effort to understand the clinical elements associated with treatment decisions for RHT, this retrospective multi-center cohort study evaluated a real-world diverse patient population treated at two academic medical centers with PE response team (PERT) programs who presented with RHT, with and without PE, and evaluated the associated treatment strategies and outcomes. This study examined the clinical features and outcomes among patients presenting with RHT who were treated with anticoagulation monotherapy, systemic thrombolysis, and advanced intervention. Outcomes of interest included 30-day mortality, duration of hospitalization, need for ICU admission, bleeding complications, and in-hospital mortality. A total of 48 adult patients with RHT identified by transthoracic echocardiography (TTE) between January 2010 and December 2022 were included. Most patients with RHT presented with intermediate-high or high risk PE with right heart dysfunction. Mortality at 30 days was higher in the anticoagulation monotherapy group when compared to the systemic thrombolysis and advanced intervention groups, though not reaching statistical significance (25 % vs 11 % and 5.6 %, respectively). Other outcomes were not significantly different between groups. Although it is not clear that advanced therapy offers a benefit in this population overall, there are likely patients who will benefit; identifying that subpopulation remains a key question.</div></div>","PeriodicalId":23064,"journal":{"name":"Thrombosis research","volume":"257 ","pages":"Article 109557"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145715858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}