Hypothermia During Intracranial Aneurysm Surgery Trial
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|ClinicalTrials.gov Identifier: NCT00029133|
Recruitment Status : Completed
First Posted : January 9, 2002
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Aneurysm Hypothermia Subarachnoid Hemorrhage||Procedure: mild intraoperative hypothermia (33 degrees Celsius)||Phase 3|
The purpose of this trial is to determine whether mild intraoperative body cooling (body temperature = 33 degrees Celsius or 91.4 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Study Start Date :||February 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00029133
|United States, Iowa|
|University of Iowa, Department of Anesthesia, 6505-5 John Colloton Pavilion|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Michael Todd, M.D.||University of Iowa|