Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
Overview of rFVIIa Use for Pediatric Cardiac Surgery
A total of 40 patients received rFVIIa prophylaxis in one poor-quality RCT (the only included study). This yielded an insufficient strength of evidence and fair applicability for the population targeted—infant patients with congenital heart defects requiring surgical repair. Current evidence is insufficient for comparing the harms and benefits of rFVIIa use in infant patients undergoing cardiac surgery for congenital heart defect repair. The importance and nature of interactions between rFVIIa administration, extracorporeal membrane oxygenation use, and the risk of thromboembolic events remain uncertain.
- Ekert H, Brizard C, Eyers R, et al. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis 2006;17:389-95.
- Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review 21 (Prepared by Stanford–UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Publication No. 10-EHC030-EF.
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