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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

Slide: 26 of 36

Evidence of rFVIIa Use for Adult Cardiac Surgery vs. Usual Care

Despite advances in methods to control blood loss during and after cardiac surgery, perioperative blood transfusions are required in up to 80 percent of adult patients, and 3 to 5 percent of these patients require postoperative transfusions of over 10 RBC units. Postoperative bleeding that is refractory to surgical re-exploration or conventional hemostatic therapy is felt to be multifactorial, with contributions from the use of antiplatelet agents prior to surgery and various causes of coagulopathy triggered by the surgery itself. There were two RCTs (one good quality, one fair quality) and four comparative observational studies (two good quality, two fair quality) with 251 patients receiving rFVIIa. One of the RCTs assessed prophylactic rFVIIa use, whereas the rest of the studies evaluated treatment use.