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Hypothermia During Intracranial Aneurysm Surgery Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00029133
First Posted: January 9, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
  Purpose
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.

Condition Intervention Phase
Aneurysm Hypothermia Subarachnoid Hemorrhage Procedure: mild intraoperative hypothermia (33 degrees Celsius) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Estimated Enrollment: 1000
Study Start Date: February 2000
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Iowa
University of Iowa, Department of Anesthesia, 6505-5 John Colloton Pavilion
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Michael Todd, M.D. University of Iowa
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00029133     History of Changes
Other Study ID Numbers: R01NS038554 ( U.S. NIH Grant/Contract )
First Submitted: January 8, 2002
First Posted: January 9, 2002
Last Update Posted: December 9, 2005
Last Verified: August 2003

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
aneurysm
hypothermia
subarachnoid intracranial hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Aneurysm
Hypothermia
Subarachnoid Hemorrhage
Intracranial Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases