Acute haemorrhagic stroke
Conditions
Brief summary
Part 1: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 180 days: 0-2, 3, and 4-6. Part 2: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 90 days: 0-2, 3, and 4-6.
Detailed description
Secondary Endpoints include the ordinal mRS (all seven steps)routine CT, utility-weighted Rankin Score, mRS of 0-2, and EQ-5D at 90 days and 180 days; the trichotomous endpoint at 180 days for Part 2;and change in the volume of ICH and ICH-IVH (intraventricular hemorrhage) between the baseline routine CT and 24- hour routine CT.
Interventions
DRUGEptacog alfa Placebo
Sponsors
University Of Cincinnati College Of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 180 days: 0-2, 3, and 4-6. Part 2: The primary outcome measure is the following distribution of the ordinal mRS (modified Rankin Score) at 90 days: 0-2, 3, and 4-6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints include the ordinal mRS (all seven steps)routine CT, utility-weighted Rankin Score, mRS of 0-2, and EQ-5D at 90 days and 180 days; the trichotomous endpoint at 180 days for Part 2;and change in the volume of ICH and ICH-IVH (intraventricular hemorrhage) between the baseline routine CT and 24- hour routine CT. | — |
Countries
Germany, Spain
Outcome results
None listed