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

AbstractBACKGROUND:
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.
AuthorsR Imberti, L Pietrobono, C Klersy, G Gamba, G A Iotti, G Cornara
JournalMinerva anestesiologica (Minerva Anestesiol) Vol. 78 Issue 2 Pg. 168-75 (02 2012) ISSN: 1827-1596 [Electronic] Italy
PMID21750485 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
Chemical References
  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa
Topics
  • Cerebral Hemorrhage (surgery)
  • Factor VIIa (administration & dosage)
  • Female
  • Hematoma (pathology, prevention & control)
  • Humans
  • Infusions, Intravenous
  • Intraoperative Care
  • Male
  • Middle Aged
  • Postoperative Complications (pathology, prevention & control)
  • Prospective Studies
  • Recombinant Proteins (administration & dosage)
  • Single-Blind Method
  • Time Factors

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