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