Clinical trial registration number: NCT02950168, NCT02951039.
Clinical trial registration number: NCT02950168, NCT02951039.
This study investigates the prevalence and risk factors associated with venous thrombotic events in patients receiving (ECMO) support. Systematic review and meta-analysis of case-control and cohort studies. PubMed, Cochrane Library, Embase, CINAHL, Web of Science, Scopus, and ProQuest databases from inception through November 25, 2023.Case-control and cohort studies focusing on the prevalence and risk factors for venous thrombotic events in patients supported by ECMO. Identification of risk factors and calculation of incidence rates. Nineteen studies encompassing 10,767 participants were identified and included in the analysis. The pooled prevalence of venous thrombotic events among patients receiving ECMO support was 48% [95% confidence interval (CI) 0.37-0.60, I2 = 97.18%]. Factors associated with increased incidence rates included longer duration of ECMO support (odds ratio [OR] 1.08, 95% CI 1.07-1.09, I2 = 49%), abnormal anti-coagulation monitoring indicators (OR 1.02, 95% CI 1.00-1.04, I2 = 84%), and type of ECMO cannulation (OR 1.77, 95% CI 1.14-3.34, I2 = 64%). The pooled prevalence of venous thrombotic events in patients with ECMO support is high. Increased risk is associated with extended duration of ECMO support, abnormal anti-coagulation monitoring, and specific types of ECMO cannulation.
The study aims to evaluate the prognosis and risk factors of sepsis-associated thrombocytopenia (SAT) among patients with coagulopathy, and to provide evidence of the relationship between adverse outcomes and potential risks. Patients with sepsis-associated coagulopathy were included in the study from January 2014 to December 2022. The primary outcome was sepsis-associated thrombocytopenia (platelet count less than 100 *109/L), which was evaluated by logistic regression models adjusted for demographic characteristics and comorbidities. Among patients in the SAT group, 54% developed severe SAT, while 16% of these patients recovered from thrombocytopenia. The in-hospital mortality rate was significantly higher in the SAT group compared to the non-SAT group (31% in SAT group vs 23.9% in non-SAT group, p = 0.029). Even after adjusting for age, gender, Charlson comorbidity, white blood cell, and Sequential Organ Failure Assessment score, the differences in mortality rate persisted (Odds Ratio 0.72, [95% Confidence Interval 0.52-0.92]). Correlation analyses revealed that prothrombin time (r = 0.08, p = 0.50), international normalized ratio (r = 0.08, p = 0.42), prothrombin activity (r = -0.06, p > 0.999), D-dimer (r = -0.02, p > 0.999), and inflammatory parameters such as C-reactive protein (r = -0.11, p = 0.37) were not significantly correlated with platelet counts. According to subgroup analyses, patients with lung infection complicated by SAT had slightly higher mortality (OR 0.66, [95% CI, 0.46 to 0.94]). Sepsis-associated coagulopathy indicates a subset of critical ill patients, with those experiencing thrombocytopenia at greater risk for in-hospital death compared to those without it.
Venous thromboembolism is a serious safety concern in women using combined oral contraceptives; ethinyl estradiol (EE) is widely used as an estrogen. Estetrol (E4) is a native estrogen with selective tissue activity and exclusively produced by the fetal liver. This study used a multicenter, randomized, open-label, active-controlled, parallel-group design to evaluate the effects of E4 combined with drospirenone (DRSP) on coagulation and fibrinolysis in Japanese patients with endometriosis. Participants were randomized to receive either E4 15 mg/DRSP 3 mg or EE 20 µg/DRSP 3 mg for 12 weeks. E4/DRSP and EE/DRSP were administered orally once a day in a cyclic regimen, ie, 24-day active use followed by a 4-day hormone-free period, and a flexible extended regimen, respectively, and blood coagulation and fibrinolysis markers were measured. The effect on coagulation and fibrinolysis was considerably less in the E4/DRSP group than in the EE/DRSP group. Major anticoagulant proteins, protein S (free, total) and tissue factor pathway inhibitor (free), were reduced following EE/DRSP treatment. Consequently, thrombin generation determined by the activated protein C sensitivity ratio was increased by approximately 4-fold in the EE/DRSP group than in the E4/DRSP group. Eventually, the fibrinolysis cascade was triggered to compensate for disturbed coagulation, and D-dimer levels were 4.7-fold higher in the EE/DRSP group than in the E4/DRSP group. This study demonstrated that the effect of E4/DRSP on the blood coagulation and fibrinolysis cascades was significantly less than that of EE/DRSP in participants with endometriosis, a disease of women of advanced and reproductive age (jRCT2080225090, https://jrct.niph.go.jp/en-latest-detail/jRCT2080225090).
Objective: To systematically assess the risk prediction models for preoperative deep vein thrombosis in older patients with hip fractures.
Method: We searched four databases for literature through November 17, 2023. We included patients aged ≥60 with hip fractures and considered English-language case-control or cohort studies that focused on developing and/or validating risk prediction models for DVT in this population. Excluded were studies that solely analyzed risk factors without constructing a prediction model, had fewer than 2 predictive variables, or were not available in full-text or were duplicate publications. The Predictive Model Bias Risk Assessment tool was utilized to evaluate risk of bias. The area under the curve (AUC) values were meta-analyzed using R Studio software. The I2 index and Cochrane q test were employed to assess heterogeneity. Additionally, sensitivity analysis was performed by systematically removing individual studies to explore the sources of heterogeneity.
Results: A total of 1880 studies were gathered. Out of these, seven studies were included, encompassing 8 models. The most commonly utilized factors in the models were D-dimer and the time from injury to admission. The pooled AUC value for the validation of 8 models was 0.84 (95% confidence interval: 0.80-0.87), indicating robust model performance.
Conclusion: Current risk prediction models for preoperative DVT in elderly hip fracture patients are still in the developmental phase. Future research should focus on developing new models with larger sample sizes, robust study designs, and multicenter external validation.
Platelets are crucial for maintaining physiological equilibrium, thrombosis formation, inflammation, bacterial defense, wound repair, angiogenesis, and tumorigenesis. In the Pediatric Intensive Care Unit (PICU), children frequently exhibit platelet reductions or functional alterations due to diverse pathological conditions, which significantly influence disease progression and therapeutic approaches. We analyzed the association between platelets count and its derived parameters and all-cause mortality. Adjusted smoothing spline plots, subgroup analysis and segmented multivariate logistic regression analysis were conducted to estimate the relative risk between proportional risk between platelets and all-cause mortality. Of the 11625 children, 677 (5.82%) died. After adjusting for confounders, there was a negative association between platelets and the risk of all-cause mortality in PICU. For every 100 × 10^9/L increase in platelets, the risk of death was reduced by 17% (adjusted OR = 0.83, 95% CI: 0.78, 0.89). The results of sensitivity analysis showed that in different stratified analyses (age, ICU category,WBC Count), the effect of platelets count on all-cause mortality remained stable. After adjusting for inflammation, nutrition, and liver function factors, platelets reduction is still an independent risk factor for PICU all-cause mortality.
Background: Direct oral anticoagulants (DOACs) have been widely applied in adults for thrombosis prophylaxis. However, the effect of DOACs in pediatric patients with congenital or acquired heart diseases who need anticoagulation therapy remains unclear.
Methods: We systematically searched the databases of PubMed, Embase, and the Cochrane Library, as well as the ClinicalTrials.gov registry and the World Health Organization's International Clinical Trials Registry Platform until June 2024 to identify relevant randomized clinical trials (RCTs). If the number of included studies was less than 5, we performed a narrative review to assess the effect of DOACs in pediatric patients.
Results: Four studies were included. In the UNIVERSE study, thrombotic events occurred in 2% of the rivaroxaban group and 9% of the aspirin group, with bleeding events in 36% and 41%, respectively. The ENNOBLE-ATE study showed no thromboembolic events in the edoxaban group and 1.7% in the SOC group (rate difference: -0.07%, 95% CI: -0.22 to 0.07%). Major bleeding rates were similar (rate difference: -0.03%, 95% CI: -0.18 to 0.12%). The SAXOPHONE trial showed no thromboembolic events in either group and similar major bleeding rates (-0.8%, 95% CI: -8.1 to 3.3%). In the DIVERSITY trial, 81% of dabigatran patients achieved the primary outcome versus 59.3% in the SOC group (Odds ratio: 0.342, 95% CI: 0.081-1.229). No major bleeding occurred in either group.
Conclusion: Existing studies suggest that the use of DOACs hold promise as an effective and safe alternative for preventing and treating thromboembolism in pediatric patients with heart conditions.
Anticoagulation management using warfarin is challenging in clinical practice. This study aimed to evaluate the knowledge, adherence, and satisfaction with warfarin therapy and associated factors among outpatients at the Tikur Anbessa Specialized Hospital (TASH) in Addis Ababa, Ethiopia. An interview-based cross-sectional study was conducted among 350 patients receiving warfarin therapy at cardiac and hematology clinics of TASH. Anticoagulation knowledge assessment (AKA) questionnaires assessed the patients' warfarin knowledge. Adherence to warfarin was evaluated using the Morisky Green Levine Scale (MGLS), and patient satisfaction with warfarin therapy was assessed using the 17-item anticlot treatment scale (ACTS). Binary logistic regression was used to determine factors associated with the outcome variables, and p < .05 was used as the cut-off point to declare a significant association. The mean AKA score was 59.35 ± 13.04% (10.68 ± 2.34 correct answers), and 82 (23.4%) of participants achieved a passing score. Based on the MGLS, 192 (54.9%) study participants adhered well to warfarin. The mean level of satisfaction was 53.67 ± 8.56, with mean scores of 41.93 ± 7.80 and 11.74 ± 2.43 in the ACTS burden and benefit subscales, respectively. One hundred eighty-four (52.6%) patients were satisfied with warfarin therapy. The absence of hyperthyroidism was significantly associated with poor knowledge of warfarin therapy (adjusted odds ratio [AOR] = 4.28, 95% confidence interval [CI]: 1.01-18.22). Those living with family had a 56% lower chance of poor warfarin adherence (AOR: 0.44; 95% CI: 0.21-0.93) than those living alone. This study shows room for improvement in patient knowledge, adherence, and satisfaction with warfarin therapy.
Cardiovascular disease is a prevalent complication in patients with end-stage renal disease (ESRD) on maintenance hemodialysis. In the ESRD patient population, cardiovascular mortality is 20 times higher compared to the general population. The strong relationship between both illnesses can be explained through cardiorenal syndrome (CRS). CRS encompasses a spectrum of disorders involving both the heart and kidneys in which acute or chronic dysfunction in one organ may induce a similar effect in the other organ. Current literature reveals that inflammation and thrombosis are integral to CRS development. Hence, this study aims to demonstrate whether thromboinflammatory biomarkers and laboratory parameters correlate with ESRD progression and the development of CRS. Ninety-five ESRD patients were recruited at Loyola University Medical Center hemodialysis unit. Epic chart analysis was used to determine patients with CRS. Biomarkers (C-reactive protein, tumor necrosis factor alpha, interleukin-6, Annexin V, L-fatty acid binding protein, monocyte chemoattractant protein 1, nitric oxide, von Willebrand factor, D-dimer, and plasminogen activator inhibitor-1) were profiled using the enzyme-linked immunosorbent assay method in patients with and without CRS in the ESRD cohort. All biomarkers were significantly elevated in ESRD patients compared to normal controls (P < .05) and laboratory parameters, ferritin (521.99 ± 289.33) and PTH (442.91 ± 1.50). Through EPIC chart analysis 47% of ESRD patients have CRS. D-dimer and TNF-α were significantly elevated in patients with CRS compared to patients without CRS. This study suggests that biomarkers, D-dimer, and TNF-α, can be good predictors of CRS in ESRD patients.
Objective: To examine the effectiveness of rivaroxaban compared to enoxaparin in patients diagnosed with cancer and venous thromboembolism.
Methods: A search of Pub Med, Scopus, and Google Scholar, from inception through April 2023 was conducted. Articles comparing rivaroxaban with enoxaparin in patients with cancer and VTE/PE/DVT were included. Review Manager Version 5.2 was utilised for the analysis of the following outcomes; VTE, PE, DVT, major bleeding, and mortality.
Results: A total of 8 articles and 2276 patients were included in the final analysis. Pooled analysis showed that rivaroxaban had a statistically insignificant reduced association with VTE occurrence (RR:0.83, 95% CI:0.58-1.18, P:0.3) as well as a statically insignificant reduction in major bleeding (RR:0.79, 95% CI:0.53-1.18, P:0.25). Analysis showcased that there was an insignificant reduction of mortality rivaroxaban as compared to enoxaparin (RR:0.74, 95% CI: 0.46-1.20, P:0.23).
Conclusion: Rivaroxaban can serve as a viable alternative to enoxaparin, with no appreciable drawbacks, for preventing and managing VTE in patients with malignancy.
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