Subarachnoid Hemorrhage Clinical Trial
NCT number | NCT00029133 |
Other study ID # | R01NS038554 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | January 8, 2002 |
Last updated | June 23, 2005 |
Start date | February 2000 |
This is a large multi-center, prospective, randomized trial designed to determine whether mild intraoperative hypothermia results in improved neurological outcome in patients with an acute subarachnoid hemorrhage (SAH) who are undergoing an open craniotomy to clip their aneurysms.
Status | Completed |
Enrollment | 1000 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
- Adult greater than 18 years old - Non-obese (body mass index less than 35kg/m2) - Non-pregnant - World Federation of Neurologic Surgeons preoperative Grade I, II, or III patients with acute SAH and scheduled to undergo open craniotomies for aneurysm clipping within 14 days of a documented SAH. - There must be no contraindications to cooling (e.g., sickle cell anemia, cryoglobulinemia, or severe Raynaud's disease). - Patients must also have pre-SAH Rankin disability scores of 0 to 1 (i.e., no serious pre-existing functional disability of any kind), and a perioperative course of Nimodipine (a calcium-channel blocker and the only drug known to improve outcome in patients with SAH) must be planned. - Each center must have approval from their local Human Subjects Committee to participate in the trial and written informed consent from either the patient, next-of-kin, or legal guardian is required. |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa, Department of Anesthesia, 6505-5 John Colloton Pavilion | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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