Effect of recombinant Factor VIIa on outcome of acute variceal bleeding: An individual patient based meta-analysis of two controlled trials

2014 ◽  
Vol 61 (2) ◽  
pp. 252-259 ◽  
Author(s):  
Flemming Bendtsen ◽  
Gennaro D’Amico ◽  
Ea Rusch ◽  
Roberto de Franchis ◽  
Per Kragh Andersen ◽  
...  
2020 ◽  
Author(s):  
Ying Zhang ◽  
Yuting Wang ◽  
Youfa Zhou ◽  
Jian Li ◽  
Haiyan Zhou

Abstract Background: Despite widely use of recombinant factor VIIa (rFVIIa) for bleeding in patients without haemophilia, its efficiency and safety remain unclear. Therefore, we carried out a meta-analysis on this topic. Methods: We searched Cochrane Library, Web of Science, PubMed and Embase, from January 2008 to July 2019 for randomized controlled trials on the topic. The results of this work are synthesized and reported in accordance with the PRISMA statement. Results: Twelve trials met our inclusion criteria. rFVIIa over 200ug/kg reduced red blood cell (RBC) transfusions within 24 h by 232.34ml (95% confidence interval [CI]; -410.31 to -54.37). rFVIIa did not significantly reduce 30-day mortality (relative risk [RR], 1.00; 95%CI, 0.82-1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94-1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92-2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU staying (RR, 0.40; 95%CI, -1.28 to 2.07) and number of patients transfused RBC (RR, 0.94; 95%CI, 0.83-1.08). However, rFVIIa may increase the incidence of arterial thrombotic events (RR, 1.38; 95%CI, 1.08–1.77). Conclusion: rFVIIa over 200ug/kg reduced RBC transfusions for bleeding in patients without haemophilia. However, it may increase the risk of arterial thrombotic events.


2019 ◽  
Author(s):  
Ying Zhang ◽  
Yuting Wang ◽  
Youfa Zhou ◽  
Jian Li ◽  
Haiyan Zhou

Abstract Background: Recombinant factor VIIa (rFVIIa) is widely used for off-label indications to control bleeding and reduce blood transfusion. However, the efficacy and safety of rFVIIa for bleeding in patients without haemophilia are uncertain and worthy of further study. This meta-analysis has been updated to incorporate recent trial data.Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PUBMED, EMBASE and other medical databases up to 20 July 2019. The results of this work are synthetized and reported in accordance with the PRISMA statement.Results: Twelve trials met our inclusion criteria. High dose rFVIIa reduced the requirements of red cell transfusion (mean difference [MD], -232.34; 95% confidence interval [CI]; -448.33 to 234.89). rFVIIa did not significantly affect mortality (relative risk[RR], 1.00;95%CI, 0.82–1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94–1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92–2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU-stay (RR, 0.40; 95%CI, -1.28 to 2.07) and numbers of patients for red cell transfusion (RR, 0.94; 95%CI, 0.83-1.08). However, it may increase the incidence of arterial events (RR, 1.38; 95%CI, 1.08–1.77).Conclusion: High dose rFVIIa is effective to reduce the need of red cell transfusion for bleeding in patients without haemophilia. However, it may increase the risk of arterial events.


2020 ◽  
Vol 73 ◽  
pp. S723-S724
Author(s):  
Juan Carlos Garcia Pagan ◽  
Oana Nicoara-Farcau ◽  
Debora Angrisani ◽  
Alberto Monescillo ◽  
Guohong Han ◽  
...  

2005 ◽  
Vol 39 (5) ◽  
pp. 885-891 ◽  
Author(s):  
Masha SH Lam ◽  
Rosalyn P Sims-McCallum

OBJECTIVE: To review the clinical evidence for the use of recombinant factor VIIa (rFVIIa) in the prevention and/or treatment of bleeding in non-hemophiliac patients. DATA SOURCES: A MEDLINE search (1966–December 2004) was conducted to identify pertinent literature. Results were limited to English-language reports and clinical trials. References of relevant articles and selected abstracts presented at scientific meetings were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Human data from prospective and retrospective studies that examined the hemostatic effect of rFVIIa in non-hemophiliac patients were reviewed, with a focus on surgical prophylaxis, liver disease, intractable bleeding associated with trauma and surgery, and anticoagulation reversal. DATA SYNTHESIS: Results from limited controlled trials on the use of rFVIIa as an adjunct for prevention of bleeding in surgery and liver diseases have not been consistent. For treatment of intractable bleeding, earlier use of rFVIIa in one trauma trial was shown to decrease the number of blood transfusions, but no differences in terms of clinical outcomes were observed in all trials. Controlled trials do not suggest an increased risk of thrombotic events. Optimal dosing and timing of administration have yet to be defined. CONCLUSIONS: Until further prospective controlled data are available, it is recommended that conventional intervention for prevention and control of hemorrhage in non-hemophiliac patients should remain the standard of care. Close monitoring of coagulation parameters is recommended before, during, and after therapy, especially in high-risk patients. Pharmacoeconomic analysis may be useful to help control costs and maximize clinical benefits.


Sign in / Sign up

Export Citation Format

Share Document