-
Journal of Clinical Medicine Nov 2023Postthrombotic syndrome (PTS) has a major impact on the quality of life after deep venous thrombosis (DVT). From clinical practice and related trials, anticoagulants... (Review)
Review
A Systematic Review and Bayesian Network Meta-Analysis on the Effect of Different Anticoagulants on the Prophylaxis of Post-Thrombotic Syndrome after Deep Venous Thrombosis.
BACKGROUND
Postthrombotic syndrome (PTS) has a major impact on the quality of life after deep venous thrombosis (DVT). From clinical practice and related trials, anticoagulants show potential for reducing the occurrence and alleviating the symptoms of PTS.
METHODS
A systematic review and Bayesian network meta-analysis (NMA) were conducted by combing the literature from the databases of MEDLINE, Embase, Web of Science, Cochrane Libraries, and ClinicalTrials, through a variety of medical subject headings (Mesh) and PTS keywords. With regard to PTS prophylaxis, all anticoagulant-related randomized controlled trials (RCTs) and observational studies were assessed. The network model was conducted through the R software, and further comparisons were conducted using the Bayesian hierarchical random effects model. The odds ratio (OR) and the corresponding 95% CI were calculated for analysis.
RESULTS
Data from two RCTs and nine non-randomized studies meeting the selection criteria were included in the Bayesian analysis model, which incorporated seven anticoagulants. Edoxaban (OR: 0.42, 95% CI: 0.18-1.0) and rivaroxaban (OR: 0.54, 95% CI: 0.38-0.76) were significantly more effective than warfarin in the prevention of PTS (Villalta score ≥ 5). A subgroup analysis based on the severity of PTS showed that rivaroxaban was more effective than warfarin, with OR: 0.59, 95% CI: 0.41-0.84 (Villalta score 5 to 14) and OR: 0.48, 95% CI: 0.22-0.9 (Villalta score ≥ 15, ulceration), respectively. Edoxaban had the highest probability (80.1%) of providing preventive benefits for PTS. For mild/moderate and severe PTS, rivaroxaban provided the highest benefits in preventing PTS (89.3% and 85.6%, respectively).
CONCLUSION
Edoxaban demonstrated a better prophylactic effect on PTS (Villalta score > 5), while rivaroxaban displayed a better effect against mild/moderate (Villalta score 5 to 14) and severe PTS (Villalta score ≥ 15, ulceration).
PubMed: 38068502
DOI: 10.3390/jcm12237450 -
The Cochrane Database of Systematic... Aug 2023The coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have been published, and researchers have described that people with COVID-19 are at high risk for developing venous thromboembolism (VTE). Anticoagulants have been used as pharmacological interventions to prevent arterial and venous thrombosis, and their use in the outpatient setting could potentially reduce the prevalence of vascular thrombosis and associated mortality in people with COVID-19. However, even lower doses used for a prophylactic purpose may result in adverse events such as bleeding. It is important to consider the evidence for anticoagulant use in non-hospitalised people with COVID-19.
OBJECTIVES
To evaluate the benefits and harms of prophylactic anticoagulants versus active comparators, placebo or no intervention, or non-pharmacological interventions in non-hospitalised people with COVID-19.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 18 April 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing prophylactic anticoagulants with placebo or no treatment, another active comparator, or non-pharmacological interventions in non-hospitalised people with COVID-19. We included studies that compared anticoagulants with a different dose of the same anticoagulant. We excluded studies with a duration of under two weeks.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. Our primary outcomes were all-cause mortality, VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE)), and major bleeding. Our secondary outcomes were DVT, PE, need for hospitalisation, minor bleeding, adverse events, and quality of life. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included five RCTs with up to 90 days of follow-up (short term). Data were available for meta-analysis from 1777 participants. Anticoagulant compared to placebo or no treatment Five studies compared anticoagulants with placebo or no treatment and provided data for three of our outcomes of interest (all-cause mortality, major bleeding, and adverse events). The evidence suggests that prophylactic anticoagulants may lead to little or no difference in all-cause mortality (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.04 to 3.61; 5 studies; 1777 participants; low-certainty evidence) and probably reduce VTE from 3% in the placebo group to 1% in the anticoagulant group (RR 0.36, 95% CI 0.16 to 0.85; 4 studies; 1259 participants; number needed to treat for an additional beneficial outcome (NNTB) = 50; moderate-certainty evidence). There may be little to no difference in major bleeding (RR 0.36, 95% CI 0.01 to 8.78; 5 studies; 1777 participants; low-certainty evidence). Anticoagulants probably result in little or no difference in DVT (RR 1.02, 95% CI 0.30 to 3.46; 3 studies; 1009 participants; moderate-certainty evidence), but probably reduce the risk of PE from 2.7% in the placebo group to 0.7% in the anticoagulant group (RR 0.25, 95% CI 0.08 to 0.79; 3 studies; 1009 participants; NNTB 50; moderate-certainty evidence). Anticoagulants probably lead to little or no difference in reducing hospitalisation (RR 1.01, 95% CI 0.59 to 1.75; 4 studies; 1459 participants; moderate-certainty evidence) and may lead to little or no difference in adverse events (minor bleeding, RR 2.46, 95% CI 0.90 to 6.72; 5 studies, 1777 participants; low-certainty evidence). Anticoagulant compared to a different dose of the same anticoagulant One study compared anticoagulant (higher-dose apixaban) with a different (standard) dose of the same anticoagulant and reported five relevant outcomes. No cases of all-cause mortality, VTE, or major bleeding occurred in either group during the 45-day follow-up (moderate-certainty evidence). Higher-dose apixaban compared to standard-dose apixaban may lead to little or no difference in reducing the need for hospitalisation (RR 1.89, 95% CI 0.17 to 20.58; 1 study; 278 participants; low-certainty evidence) or in the number of adverse events (minor bleeding, RR 0.47, 95% CI 0.09 to 2.54; 1 study; 278 participants; low-certainty evidence). Anticoagulant compared to antiplatelet agent One study compared anticoagulant (apixaban) with antiplatelet agent (aspirin) and reported five relevant outcomes. No cases of all-cause mortality or major bleeding occurred during the 45-day follow-up (moderate-certainty evidence). Apixaban may lead to little or no difference in VTE (RR 0.36, 95% CI 0.01 to 8.65; 1 study; 279 participants; low-certainty evidence), need for hospitalisation (RR 3.20, 95% CI 0.13 to 77.85; 1 study; 279 participants; low-certainty evidence), or adverse events (minor bleeding, RR 2.13, 95% CI 0.40 to 11.46; 1 study; 279 participants; low-certainty evidence). No included studies reported on quality of life or investigated anticoagulants compared to a different anticoagulant, or anticoagulants compared to non-pharmacological interventions.
AUTHORS' CONCLUSIONS
We found low- to moderate-certainty evidence from five RCTs that prophylactic anticoagulants result in little or no difference in major bleeding, DVT, need for hospitalisation, or adverse events when compared with placebo or no treatment in non-hospitalised people with COVID-19. Low-certainty evidence indicates that prophylactic anticoagulants may result in little or no difference in all-cause mortality when compared with placebo or no treatment, but moderate-certainty evidence indicates that prophylactic anticoagulants probably reduce the incidence of VTE and PE. Low-certainty evidence suggests that comparing different doses of the same prophylactic anticoagulant may result in little or no difference in need for hospitalisation or adverse events. Prophylactic anticoagulants may result in little or no difference in risk of VTE, hospitalisation, or adverse events when compared with antiplatelet agents (low-certainty evidence). Given that there were only short-term data from one study, these results should be interpreted with caution. Additional trials of sufficient duration are needed to clearly determine any effect on clinical outcomes.
Topics: Humans; Anticoagulants; Platelet Aggregation Inhibitors; COVID-19; Venous Thromboembolism; Aspirin; Pulmonary Embolism
PubMed: 37591523
DOI: 10.1002/14651858.CD015102.pub2 -
Vascular and Endovascular Surgery Aug 2023Spontaneous iliac vein rupture is a rare, but frequently lethal condition. It is important to timely recognize its clinical features and immediately start adequate... (Review)
Review
INTRODUCTION
Spontaneous iliac vein rupture is a rare, but frequently lethal condition. It is important to timely recognize its clinical features and immediately start adequate treatment. We aimed to increase awareness to clinical features, specific diagnostics, and treatment strategies of spontaneous iliac vein rupture by evaluating the current literature.
METHODS
A systematic search was conducted in EMBASE, Ovid MEDLINE, Cochrane, Web of Science, and Google Scholar from inception until January 23, 2023, without any restrictions. Two reviewers independently screened for eligibility and selected studies describing a spontaneous iliac vein rupture. Patient characteristics, clinical features, diagnostics, treatment strategies, and survival outcomes were collected from included studies.
RESULTS
We included 76 cases (64 studies) from the literature, mostly presenting with left-sided spontaneous iliac vein rupture (96.1%). Patients were predominantly female (84.2%), had a mean age of 61 years, and frequently presented with a concomitant deep vein thrombosis (DVT) (84.2%). After various follow-up times, 77.6% of the patients survived, either after conservative, endovascular, or open treatment. Endovenous or hybrid procedures were frequently performed if the diagnose was made before treatment, and almost all survived. Open treatment was common if the venous rupture was missed, for some cases leading to death.
CONCLUSION
Spontaneous iliac vein rupture is rare and easily missed. The diagnose should at least be considered for middle-aged and elderly females presenting with hemorrhagic shock and concomitant left-sided DVT. There are various treatment strategies for spontaneous iliac vein rupture. An early diagnose brings options for endovenous treatment, which seems to have good survival outcomes based on previously described cases.
Topics: Middle Aged; Aged; Humans; Female; Male; Venous Thrombosis; Iliac Vein; Treatment Outcome; Rupture, Spontaneous; Shock, Hemorrhagic; May-Thurner Syndrome
PubMed: 36913198
DOI: 10.1177/15385744231163707 -
International Journal of Molecular... Aug 2023Giant arachnoid granulations (GAGs) are minimally investigated. Here, we systematically review the available data in published reports to better understand their... (Review)
Review
Giant arachnoid granulations (GAGs) are minimally investigated. Here, we systematically review the available data in published reports to better understand their etiologies, nomenclature, and clinical significance. In the literature, 195 GAGs have been documented in 169 persons of varied ages (range, 0.33 to 91 years; mean, 43 ± 20 years; 54% female). Prior reports depict intrasinus (i.e., dural venous sinus, DVS) (84%), extrasinus (i.e., diploic or calvarial) (15%), and mixed (1%) GAG types that exhibit pedunculated, sessile, or vermiform morphologies. GAG size ranged from 0.4 to 6 cm in maximum dimension (mean, 1.9 ± 1.1 cm) and encompassed symptomatic or non-symptomatic enlarged arachnoid granulations (≥1 cm) as well as symptomatic subcentimeter arachnoid granulations. A significant difference was identified in mean GAG size between sex (females, 1.78 cm; males, 3.39 cm; < 0.05). The signs and symptoms associated with GAGs varied and include headache (19%), sensory change(s) (11%), and intracranial hypertension (2%), among diverse and potentially serious sequelae. Notably, brain herniation was present within 38 GAGs (22%). Among treated individuals, subsets were managed medically (19 persons, 11%), surgically (15 persons, 9%), and/or by endovascular DVS stenting (7 persons, 4%). Histologic workup of 53 (27%) GAG cases depicted internal inflammation (3%), cystic change consistent with fluid accumulation (2%), venous thrombosis (1%), hemorrhage (1%), meningothelial hyperplasia (1%), lymphatic vascular proliferation (1%), and lymphatic vessel obliteration (1%). This review emphasizes heterogeneity in GAG subtypes, morphology, composite, location, symptomatology, and imaging presentations. Additional systematic investigations are needed to better elucidate the pathobiology, clinical effects, and optimal diagnostic and management strategies for enlarged and symptomatic arachnoid granulation subtypes, as different strategies and size thresholds are likely applicable for medical, interventional, and/or surgical treatment of these structures in distinct brain locations.
Topics: Male; Humans; Female; Brain; Clinical Relevance; Disease Progression; Headache; Vascular Diseases; Arachnoid
PubMed: 37629195
DOI: 10.3390/ijms241613014 -
European Journal of Haematology Dec 2023Accurate diagnostic and prognostic predictions of venous thromboembolism (VTE) are crucial for VTE management. Artificial intelligence (AI) enables autonomous...
BACKGROUND
Accurate diagnostic and prognostic predictions of venous thromboembolism (VTE) are crucial for VTE management. Artificial intelligence (AI) enables autonomous identification of the most predictive patterns from large complex data. Although evidence regarding its performance in VTE prediction is emerging, a comprehensive analysis of performance is lacking.
AIMS
To systematically review the performance of AI in the diagnosis and prediction of VTE and compare it to clinical risk assessment models (RAMs) or logistic regression models.
METHODS
A systematic literature search was performed using PubMed, MEDLINE, EMBASE, and Web of Science from inception to April 20, 2021. Search terms included "artificial intelligence" and "venous thromboembolism." Eligible criteria were original studies evaluating AI in the prediction of VTE in adults and reporting one of the following outcomes: sensitivity, specificity, positive predictive value, negative predictive value, or area under receiver operating curve (AUC). Risks of bias were assessed using the PROBAST tool. Unpaired t-test was performed to compare the mean AUC from AI versus conventional methods (RAMs or logistic regression models).
RESULTS
A total of 20 studies were included. Number of participants ranged from 31 to 111 888. The AI-based models included artificial neural network (six studies), support vector machines (four studies), Bayesian methods (one study), super learner ensemble (one study), genetic programming (one study), unspecified machine learning models (two studies), and multiple machine learning models (five studies). Twelve studies (60%) had both training and testing cohorts. Among 14 studies (70%) where AUCs were reported, the mean AUC for AI versus conventional methods were 0.79 (95% CI: 0.74-0.85) versus 0.61 (95% CI: 0.54-0.68), respectively (p < .001). However, the good to excellent discriminative performance of AI methods is unlikely to be replicated when used in clinical practice, because most studies had high risk of bias due to missing data handling and outcome determination.
CONCLUSION
The use of AI appears to improve the accuracy of diagnostic and prognostic prediction of VTE over conventional risk models; however, there was a high risk of bias observed across studies. Future studies should focus on transparent reporting, external validation, and clinical application of these models.
Topics: Adult; Humans; Venous Thromboembolism; Artificial Intelligence; Bayes Theorem; Risk Assessment; Prognosis
PubMed: 37794526
DOI: 10.1111/ejh.14110 -
European Journal of Vascular and... Dec 2023Currently, there is no consensus on the optimal management of Paget-Schroetter syndrome (PSS). The objective was to summarise the current evidence for management of PSS... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Currently, there is no consensus on the optimal management of Paget-Schroetter syndrome (PSS). The objective was to summarise the current evidence for management of PSS with explicit attention to the clinical outcomes of different management strategies.
DATA SOURCES
The Cochrane, PubMed, and Embase databases were searched for reports published between January 1990 and December 2021.
REVIEW METHODS
A systematic review and meta-analysis was conducted following PRISMA 2020 guidelines. The primary endpoint was the proportion of symptom free patients at last follow up. Secondary outcomes were success of initial treatment, recurrence of thrombosis or persistent occlusion, and patency at last follow up. Meta-analyses of the primary endpoint were performed for non-comparative and comparative reports. The quality of evidence was assessed using the GRADE approach.
RESULTS
Sixty reports were included (2 653 patients), with overall moderate quality. The proportions of symptom free patients in non-comparative analysis were: anticoagulation (AC), 0.54; catheter directed thrombolysis (CDT) + AC, 0.71; AC + first rib resection (FRR), 0.80; and CDT + FRR, 0.96. Pooled analysis of comparative reports confirmed the superiority of CDT + FRR compared with AC (OR 13.89, 95% CI 1.08 - 179.04; p = .040, I 87%, very low certainty of evidence), AC + FRR (OR 2.29, 95% CI 1.21 - 4.35; p = .010, I 0%, very low certainty of evidence), and CDT + AC (OR 8.44, 95% CI 1.12 - 59.53; p = .030, I 63%, very low certainty of evidence). Secondary endpoints were in favour of CDT + FRR.
CONCLUSION
Non-operative management of PSS with AC alone results in persistent symptoms in 46% of patients, while 96% of patients managed with CDT + FFR were symptom free at end of follow up. Superiority of CDT + FRR compared with AC, CDT + AC, and AC + FRR was confirmed by meta-analysis. The overall quality of included reports was moderate, and the level of certainty was very low.
Topics: Humans; Upper Extremity Deep Vein Thrombosis; Thrombolytic Therapy; Treatment Outcome; Decompression, Surgical
PubMed: 37678659
DOI: 10.1016/j.ejvs.2023.08.065 -
JSES Reviews, Reports, and Techniques Nov 2023Currently, there is limited information on the incidence of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) after surgical... (Review)
Review
BACKGROUND
Currently, there is limited information on the incidence of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) after surgical treatment of proximal humerus fractures (PHFs). Therefore, the purpose of this systematic review is to evaluate the incidence of VTE, DVT, and PE following surgery for PHFs.
METHODS
A comprehensive search of several databases was performed from inception to May 27, 2022. Studies were screened and evaluated by 2 reviewers independently utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Only original, English studies that evaluated the incidences of VTE following surgical management of PHFs were included. Surgical procedures consisted of shoulder arthroplasty (SA) including both hemiarthroplasty (Hemi) and reverse shoulder arthroplasty (RSA) in addition to open reduction and internal fixation (ORIF). A pooled incidence for postoperative DVT, PE, and overall VTE was reported.
RESULTS
Twelve studies met the inclusion and exclusion criteria, encompassing a total of 18,238 patients. The overall DVT, PE, and VTE rates were 0.14%, 0.59%, and 0.7%, respectively. VTE was more frequently reported after SA than ORIF, (1.27% vs. 0.53%, respectively). Among SA patients, a higher rate of DVT was seen with RSA (1.2%) with the lowest DVT rate was observed for ORIF with 0.03%.
CONCLUSIONS
Symptomatic VTEs following surgical treatment of PHFs, are rare, yet still relevant as a worrisome postoperative complication. Among the various procedures, VTE was the most frequently reported after SA when compared to ORIF, with RSA having the highest VTE rate.
PubMed: 37928990
DOI: 10.1016/j.xrrt.2023.06.003 -
Phlebology Oct 2023Post-thrombotic syndrome (PTS) is a frequent chronic complication of deep venous thrombosis (DVT). Biomarkers are potentially valuable clinical tools for handling PTS....
Biomarkers and the post-thrombotic syndrome: A systematic review of biomarkers associated with the occurrence of the post-thrombotic syndrome after lower extremity deep venous thrombosis.
INTRODUCTION
Post-thrombotic syndrome (PTS) is a frequent chronic complication of deep venous thrombosis (DVT). Biomarkers are potentially valuable clinical tools for handling PTS. The purpose of this review was to examine which biomarkers are associated with the development of PTS in adults with lower extremity DVT.
METHODS
We performed a systematic review of all English language prospective studies of biomarkers and PTS published in PubMed and EMBASE. Studies were included if diagnosing DVT by diagnostic imaging and assessing PTS by clinical scales, for example, the Villalta scale. Biomarkers of thrombophilia and pathological clot properties were not assessed. Data was reported qualitatively.
RESULTS
15 prospective studies were included. Studies varied widely in study design and methods of data analysis. Forty-six different biomarkers were examined, with seven being measured in two or more studies. The most frequently studied biomarkers were D-dimer, CRP, and IL-6. Associations between PTS and D-dimer were predominantly significant, while results on CRP and IL-6 were inconsistent. ICAM-1 was consistently associated with PTS in all studies and at all timepoints. IL-10 was significantly related to PTS development in the largest study and at all time points. Adiponectin, tPA, HRG and TAFI, MMP-1 and -8, and TIMP-1 and -2 were significantly associated with PTS in single studies.
CONCLUSION
(1) Further research on biomarkers and PTS is clearly warranted. (2) Significant differences in study designs made it difficult to draw reliable conclusions regarding individual biomarkers. We suggest the implementation of a standardized framework for the study of biomarkers and PTS, to make comparison of future studies more feasible. (3) D-dimer, ICAM-1, IL-10, MMP-1 and 8, TIMP-1, TIMP-2, and adiponectin are clinical biomarkers of particular interest to include in future studies of PTS. Large scale systemic quantitative proteomic analyses of DVT patients could help identify novel biomarkers of interest in PTS-patients.
Topics: Adult; Humans; Adiponectin; Biomarkers; Intercellular Adhesion Molecule-1; Interleukin-10; Interleukin-6; Lower Extremity; Matrix Metalloproteinase 1; Postthrombotic Syndrome; Prospective Studies; Proteomics; Risk Factors; Tissue Inhibitor of Metalloproteinase-1; Venous Thrombosis
PubMed: 37620994
DOI: 10.1177/02683555231186681 -
International Journal of Stroke :... Aug 2023Despite its importance in being among the top 10 causes of childhood death, there is limited data on the incidence of stroke in children and whether this has changed... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Despite its importance in being among the top 10 causes of childhood death, there is limited data on the incidence of stroke in children and whether this has changed over time.
AIMS
We performed a systematic review and meta-analysis to estimate the worldwide incidence rate of pediatric ischemic stroke, identify population differences, and assess trends in incidence.
METHODS
We screened three databases (Medline, Embase, and Cumulative Index of Nursing and Allied Health Literature (CINAHL)) and a Google Search was performed up to October 2021. The protocol was pre-registered: PROSPERO: CRD42021273749. Data extraction and quality assessment were independently undertaken by two reviewers. A random-effects model was used for meta-analysis using Stata SE17 to calculate the overall incidence rate. Heterogeneity was assessed using I. Meta-regression and assessment for bias were performed.
RESULTS
Out of 4166 records identified, 39 studies were included in the qualitative synthesis and the quantitative meta-analysis. The incidence rate for all ischemic strokes varied from 0.9 to 7.9 per 100,000 person-years, with a pooled incidence of 2.09 (95% confidence interval (CI): 1.57-2.76). The pooled incidence was 1.28 (95% CI: 0.75-2.19) per 100,000 person-years for arterial ischemic stroke, and 0.56 (95% CI: 0.31-1.02) per 100,000 person-years for cerebral venous sinus thrombosis. The incidence of arterial ischemic stroke was high in neonates, less than 28 days old (18.51, 95% CI: 12.70-26.97). Significant heterogeneity was observed in the initial analyses of stroke incidence estimates, and geographical region, cohort age upper limit, length of study, study quality, and study design could not explain this. The incidence rate of childhood stroke appeared remained relatively stable over time.
CONCLUSION
Our review provides estimates of global stroke incidence, including stroke subtypes, in children. It demonstrates a particularly high stroke incidence in neonates.
Topics: Infant, Newborn; Humans; Child; Stroke; Ischemic Stroke; Incidence; Research Design; Time
PubMed: 36691675
DOI: 10.1177/17474930231155336 -
Critical Care (London, England) Nov 2023Trauma-induced coagulopathy (TIC) is common in trauma patients with major hemorrhage. Prothrombin complex concentrate (PCC) is used as a potential treatment for the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Trauma-induced coagulopathy (TIC) is common in trauma patients with major hemorrhage. Prothrombin complex concentrate (PCC) is used as a potential treatment for the correction of TIC, but the efficacy, timing, and evidence to support its use in injured patients with hemorrhage are unclear.
METHODS
A systematic search of published studies was performed on MEDLINE and EMBASE databases using standardized search equations. Ongoing studies were identified using clinicaltrials.gov. Studies investigating the use of PCC to treat TIC (on its own or in combination with other treatments) in adult major trauma patients were included. Studies involving pediatric patients, studies of only traumatic brain injury (TBI), and studies involving only anticoagulated patients were excluded. Primary outcomes were in-hospital mortality and venous thromboembolism (VTE). Pooled effects of PCC use were reported using random-effects model meta-analyses. Risk of bias was assessed for each study, and we used the Grading of Recommendations Assessment, Development, and Evaluation to assess the quality of evidence.
RESULTS
After removing duplicates, 1745 reports were screened and nine observational studies and one randomized controlled trial (RCT) were included, with a total of 1150 patients receiving PCC. Most studies used 4-factor-PCC with a dose of 20-30U/Kg. Among observational studies, co-interventions included whole blood (n = 1), fibrinogen concentrate (n = 2), or fresh frozen plasma (n = 4). Outcomes were inconsistently reported across studies with wide variation in both measurements and time points. The eight observational studies included reported mortality with a pooled odds ratio of 0.97 [95% CI 0.56-1.69], and five reported deep venous thrombosis (DVT) with a pooled OR of 0.83 [95% CI 0.44-1.57]. When pooling the observational studies and the RCT, the OR for mortality and DVT was 0.94 [95% CI 0.60-1.45] and 1.00 [95% CI 0.64-1.55] respectively.
CONCLUSIONS
Among published studies of TIC, PCCs did not significantly reduce mortality, nor did they increase the risk of VTE. However, the potential thrombotic risk remains a concern that should be addressed in future studies. Several RCTs are currently ongoing to further explore the efficacy and safety of PCC.
Topics: Adult; Humans; Child; Venous Thromboembolism; Blood Coagulation Factors; Blood Coagulation Disorders; Hemorrhage; Randomized Controlled Trials as Topic
PubMed: 37919775
DOI: 10.1186/s13054-023-04688-z