title: Intraoperative intravenous administration of rFVIIa and hematoma volume after early surgery for spontaneous intracerebral hemorrhage: a randomized prospective phase II study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Direzione Scientifica, Policlinico S. Matteo Fondazione IRCCS, Pavia, Italy. r.imberti@smatteo.pv.it
authors.forename: R
authors.initials: R
authors.lastname: Imberti
authors.forename: L
authors.initials: L
authors.lastname: Pietrobono
authors.forename: C
authors.initials: C
authors.lastname: Klersy
authors.forename: G
authors.initials: G
authors.lastname: Gamba
authors.forename: G A
authors.initials: GA
authors.lastname: Iotti
authors.forename: G
authors.initials: G
authors.lastname: Cornara
mesh_terms: D002543:Cerebral Hemorrhage / Q000601:surgery*; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006406:Hematoma / Q000473:pathology* / Q000517:prevention & control*; D006801:Humans; D007262:Infusions, Intravenous; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000473:pathology* / Q000517:prevention & control*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D016037:Single-Blind Method; D013997:Time Factors
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa