NCT00029133

Hypothermia During Intracranial Aneurysm Surgery Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (planned)
• Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Aneurysm
• Hypothermia
• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	mild intraoperative hypothermia (33 degrees Celsius)

Timeline

• Start date: 2000-02-01
• First posted: 2002-01-09
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States