Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-01-08
Brief Title:
Hypothermia During Intracranial Aneurysm Surgery Trial
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institute of Neurological Disorders and Stroke NINDS
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The purpose of this trial is to determine whether mild intraoperative body cooling body temperature 33 degrees Celsius or 914 degrees Fahrenheit during open neurosurgical craniotomies for aneurysm clipping improves neurological outcome measured as 3 months after surgery in patients who have suffered an aneurismal SAH This may be the only NIH-funded trial to examine the impact of an intraoperative intervention on neurological outcome following any neurosurgical procedure and is certainly the largest trial of its kind yet undertaken
Many methods have been proposed to protect neurosurgical patients from neurological complications that can occur during and after intracranial vascular procedures However no treatment targeted at the intraoperative period has ever been systematically tested Mild hypothermia was chosen as the treatment to be tested after an extensive review of medical literature and discussions with many anesthesiologists and neurosurgeons expert in the field suggested it was the intervention most likely to be beneficial Hypothermia is also easily produced in the operating room and most anesthesiologists are familiar with managing mild hypothermia As a result the investigators felt that a trial of hypothermia was practical and reasonably safe
Many methods have been proposed to protect neurosurgical patients from neurological complications that can occur during and after intracranial vascular procedures However no treatment targeted at the intraoperative period has ever been systematically tested Mild hypothermia was chosen as the treatment to be tested after an extensive review of medical literature and discussions with many anesthesiologists and neurosurgeons expert in the field suggested it was the intervention most likely to be beneficial Hypothermia is also easily produced in the operating room and most anesthesiologists are familiar with managing mild hypothermia As a result the investigators felt that a trial of hypothermia was practical and reasonably safe
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: