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

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.

Cowper's glands and ducts: radiological findings in children.

PURPOSE: The aim of this study was to describe the radiological features of simple or dilated (syringocele) Cowper's ducts in a large paediatric population. MATERIALS AND METHODS: Voiding cystourethrography procedures performed during the past 24 years were evaluated taking into special account urethral morphology. The procedures were performed to study all sorts of possible urinary affections. RESULTS: A total of 1,676 male children (age: newborn to 18 years) underwent 2,340 voiding cystourethrographies. Opacification of Cowper's ducts was observed in nine children (0.53%) - in six (0.35%) as a thin, radiopaque image running parallel to the inferior edge of the membranous-bulbar urethra and in three (0.18%) as a dilated structure (syringocele); this was a source of significant voiding problems. CONCLUSIONS: Opacification of Cowper's ducts - even if rare - has to be recognised as a possible anatomical finding during voiding cystourethrography in paediatric patients. An accessory finding devoid of pathological meaning in most cases, it can, however, be a possible cause of voiding disorders in some instances.