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Hypothermia During Intracranial Aneurysm Surgery Trial
This study has been completed.
Study NCT00029133   Information provided by National Institute of Neurological Disorders and Stroke (NINDS)
First Received: January 8, 2002   Last Updated: June 23, 2005   History of Changes

January 8, 2002
June 23, 2005
February 2000
 
 
 
Complete list of historical versions of study NCT00029133 on ClinicalTrials.gov Archive Site
 
 
 
Hypothermia During Intracranial Aneurysm Surgery Trial
 

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.

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.

Phase III
Interventional
Treatment, Randomized
  • Aneurysm
  • Hypothermia
  • Subarachnoid Hemorrhage
Procedure: mild intraoperative hypothermia (33 degrees Celsius)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
1000
 
 
  • 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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029133
 
R01NS38554
National Institute of Neurological Disorders and Stroke (NINDS)
 
Principal Investigator: Michael Todd, M.D. University of Iowa
National Institute of Neurological Disorders and Stroke (NINDS)
August 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP