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Table 3 Studies investigating recombinant factor VIIa for anticoagulation reversal in intracranial hemorrhage

From: Treatments for reversing warfarin anticoagulation in patients with acute intracranial hemorrhage: a structured literature review

Author Study type Patient population Intervention Result Grade [14]
Bartal et al. 2007 Prospective 7 patients on warfarin with traumatic ICH All received vitamin K and between 6- 12 units of FFP. INR was still > 1.3 in all and so 40-90 μg/kg rfVIIa was given. INR went below 1.3, and all underwent neurosurgery The use of rfVIIa lowered the INR into operable range in all patients Low
Sorensen et al. 2003 Retrospective 6 patients with WAICH All received vitamin K, three received FFP. INR still > 1.5 so 10-40 μg/kg rfVIIa given to each patient. All underwent NSGY All INRs were equal to or < 1.5 within 10 min of rfVIIa being given and allowed for safe neurosurgical procedure Very low
Freeman et al. 2004 Retrospective 7 patients with symptomatic non-traumatic WAICH Treated with 15-90 μg/kg of rfVIIa. Vitamin K given to all patients as well except for one who died prior. All patients but one also received FFP. Two underwent neurosurgical procedures IV bolus rfVIIa rapidly lowered the INR to normalized levels Very low
Brody et al. 2005 Retrospective 28 patients with WAICH with INR > 1.3 15 patients received 10 mg IV or subcutaneously vitamin K and FFP. 12 patients received vitamin K, FFP, and rfVIIa as well Median time from presentation to INR < 1.3 was 8.8 h in the rfVIIa group and 32 h in the FFP group. Significantly lower. One patient with ESRD developed DIC after three doses of rfVIIa. One patient in the FFP group developed pulmonary edema Low
Nishijima et al. 2010 Retrospective 40 patients with traumatic WAICH and INR 1.3 or greater 20 patients received rfVIIa and 20 did not. In both groups some patients received pRBCs, FFP, and vitamin K. Patient characteristics were similar in both groups No difference in mortality. 7 patients died in each group. There were 4/20 thrombotic complications in the rfVIIa group and 1/20 in the control. This was not statistically significant. Time to INR normalization was faster in the rfVIIa cohort mean = 4.8 h than in the standard cohort mean = 17.5 h Low