Antihypertensive Treatment in Acute Cerebral Hemorrhage-II
- Conditions
- Cerebral Hemorrhage
- Registration Number
- JPRN-UMIN000006526
- Lead Sponsor
- niversity of Minnesota National Cerebral and Cardiovascular Center
- Brief Summary
We conducted a multicenter trial where eligible subjects with ICH were randomized to intensive (<140 mm Hg) and standard (<180 mm Hg) SBP reduction in a 1:1 ratio <4.5h. The primary outcome of death and disability was ascertained at 3-M post randomization. Compared with standard SBP reduction, intensive SBP reduction in patients with ICH did not lower the rate of death and disability despite achieving a small magnitude reduction in hematoma expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1000
Not provided
1.ICH is due to previously known neoplasms, AVM, or aneurysms 2.Intracerebral hematoma considered to be related to trauma 3.ICH located in infratentorial regions such as pons or cerebellum 4.IVH associated with intraparenchymal hemorrhage and blood completely fills one lateral ventricle or more than half of both ventricles 5.Patient to receive immediate surgical evacuation 6.Current pregnancy, parturition within previous 30 days or active lactation 7.Use of warfarin within the last 5 days and INR >4 8.A platelet count less than 50,000/mm3 9.Known sensitivity to nicardipine 10.Pre-morbid disability requiring assistance in ambulation or activities of daily living 11.Subjects living will precludes aggressive ICU management 12.Subject is currently participating in another interventional clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or disability, defined by modified Rankin scale (mRS) of 4-6 at 3 m following treatment.
- Secondary Outcome Measures
Name Time Method