Abstract | 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.
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Authors | R Imberti, L Pietrobono, C Klersy, G Gamba, G A Iotti, G Cornara |
Journal | Minerva anestesiologica
(Minerva Anestesiol)
Vol. 78
Issue 2
Pg. 168-75
(02 2012)
ISSN: 1827-1596 [Electronic] Italy |
PMID | 21750485
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Recombinant Proteins
- recombinant FVIIa
- Factor VIIa
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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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