脑血管疾病演示文稿.ppt

* DesignStudy Design: Two-phase, multicenter, double-blind, randomized, controlled study with a planned enrollment of 400 patients in 40-50 centers worldwide. Inclusion Criteria: Patients who have had a CT scan performed within 3 hours of stroke and who can be treated with factor VIIa within 60 minutes of the baseline CT are eligible for the study.Exclusion Criteria: Patients with known coagulopathy or warfarin use, ICH secondary to trauma, tumor, arteriovenous malformation, etc, deep coma, early surgical intervention, or acute thromboembolic disease will be excluded from the study. Patient Involvement: Phase IIA: Patients will be examined, including CT and angiography, to determine eligibility. Eligible patients (N = 80) will be randomized into tiered treatment and control groups, with each tier corresponding to a different factor VIIa dose. In Europe/Australasia, there will be six groups of eight patients. Within each group, six patients will receive the appropriate dose of factor VIIa (10, 20, 40, 80, 120, or 160 ug/kg, depending on the group), while the two controls in each group will receive injections of a placebo solution. In the US, patients will be divided into four groups of ten. In each group, eight of the patients will receive the appropriate dose of factor VIIa (5, 20, 40, or 80 ug/kg), and two will receive placebo injection. IV drug or placebo will be infused over 1 minute within one hour of the CT scan. All patients will be monitored for treatment-related adverse events, and will receive follow-up evaluation daily for the first five days, again at day 15, and finally at day 90. Phase IIB: Eligible patients (N = 240) will be randomized into four groups of 60: placebo, 40, 80, and 160 ug/kg factor VIIa. Drug will be administered and patients will be followed up according to the same protocol discussed in Phase IIA. .Primary Outcome: Phase IIA: Frequency of early neurological deterioration (defined by a 2-point drop in the Glasgow Outcome Scale