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

Slide: 23 of 36

Overview of rFVIIa Use in Bleeding Secondary to Body Trauma

There were two randomized controlled trials (all fair quality) and three comparative observational studies (all fair quality) with 267 patients who received rFVIIa. This yielded low strength of evidence with fair applicability for treatment use in the population targeted—patients with blunt or penetrating trauma who were not censored for early in-hospital death (defined as 24 hours or 48 hours depending on the study). The findings suggest that there was no effect of rFVIIa on mortality or thromboembolism relative to usual care. There was conflicting evidence regarding RBC transfusion requirements. For acute respiratory distress syndrome, the blunt trauma RCT demonstrated a significant reduction with rFVIIa use vs. usual care, while the remaining two studies that evaluated this outcome (the penetrating trauma RCT and one observational study) showed a nonsignificant trend in the same direction. Overall, current evidence of low strength suggests the potential for benefit and little evidence of increased harm.

Regarding subpopulations of patients, the findings suggest that patients with blunt trauma may experience greater benefits than those with penetrating trauma; greater benefits are also possible in patients with higher baseline pH, shorter time to administration, and higher platelet counts.