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

Slide: 18 of 36

Evidence for rFVIIa Use for Spontaneous Intracranial Hemorrhage vs. Usual Care

Research on this topic identified four randomized controlled trials (RCTs) (two good quality, two fair quality) and one comparative observational study (fair quality) that examined treatment use of rFVIIa in 968 intervention patients. All four RCTs focused on patients who were not on oral anticoagulation therapy (OAT) and had intracerebral hemorrhage, rather than other forms of intracranial bleeding (e.g., subarachnoid or subdural hemorrhage). The observational study examined patients on OAT who could have experienced intracerebral hemorrhage or other forms of intracranial hemorrhage (e.g., subdural bleeding). Intracerebral hemorrhage is associated with high levels of mortality and functional disability. Over one third of patients die within one month, 50 percent have poor functional status at time of discharge, and 20 percent remain institutionalized at three months. Early hematoma growth occurs even in the absence of detectable systemic coagulopathy and is an important independent predictor of mortality and morbidity. There are no proven therapies for intracerebral hemorrhage.

The purpose of this section is to describe the comparative studies of rFVIIa versus usual care for the treatment of intracranial hemorrhage, but the section necessarily focuses primarily on intracerebral hemorrhage because the majority of studies focused on this form of hemorrhage. The data for intracranial hemorrhage were analyzed according to low-, medium-, and high-dose rFVIIa groups, defined as less than or equal to 40 µg/kg, greater than 40 but less 120 µg/kg, and at least 120 µg/kg, respectively.