ORIGINAL ARTICLES   Free access

Minerva Anestesiologica 2012 February;78(2):168-75

Copyright © 2012 EDIZIONI MINERVA MEDICA

language: English

Intraoperative intravenous administration of rFVIIa and hematoma volume after early surgery for spontaneous intracerebral hemorrhage: a randomized prospective phase II study

Imberti R. ¹, Pietrobono L. ², Klersy C. ³, Gamba G. ⁴, Iotti G. A. ⁵, Cornara G. ⁶ ✉

¹ Direzione Scientifica, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy; ² Servizio di Radiodiagnostica, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy; ³ Servizio di Biomedica e Statistica, Dipartimento di Ricerca, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy; ⁴ Dipartimento di Medicina Interna, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy; ⁵ Dipartimento di Anestesia e Terapia Intensiva, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; ⁶ Dipartimento di Anestesia e Terapia Intensiva, Ospedale S. Croce e Carle, Cuneo, Italy

BACKGROUND: Surgery of spontaneous supratentorial intracerebral hemorrhage (ICH), especially if performed early, can be complicated by rebleeding, a condition that can worsen the outcome. We evaluated the effect of recombinant activated factor VII (rFVIIa) on postoperative rebleeding.
METHODS: In this randomized, open-label, single-blinded study, 21 patients with spontaneous supratentorial ICH diagnosed by computed tomography (CT) scan were treated with intravenous rFVIIa (100 mcg/Kg b.w., N=13) or placebo (N=8). Hematoma volume was assessed using CT scan immediately, 18-30 hours, and 5-7 days after hematoma evacuation. The primary endpoint was a hematoma volume at 18-30 hours after surgery. All CT scans were evaluated at one center by the same investigator who was unaware of the treatment. Hematoma volume was measured using dedicated software.
RESULTS: At baseline, the hematoma volume was 59.2±27.4 and 71.5±32.1 mL in the rFVIIa and placebo group, respectively. Hematoma evacuation resulted in significantly smaller ICH volumes that were similar in the rFVIIa and placebo group at 18-30 hours after surgery (15.9±14.2 mL and 18±15.1 mL, respectively; mean difference 2.1 mL, 95% confidence interval -12.1 to 16.2, P=0.76 (0.03 mL after adjustment for baseline value)). The frequencies of deep venous thrombosis, myocardial infarction, troponin I elevation and cerebral ischemia were similar in both groups.
CONCLUSION: In this pilot study, intraoperative, intravenous rFVIIa administration did not modify hematoma volume after early ICH surgery. However, the 95% CI was wide, which indicates considerable uncertainty. Therefore, our results do not disprove the potential benefit of rFVIIa administration, which could be shown in a larger study.