Hypothermia During Intracranial Aneurysm Surgery Trial
Sponsors
Source
National Institute of Neurological Disorders and Stroke (NINDS)
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 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.
Overall Status
Completed
Start Date
2000-02-01
Completion Date
N/A
Primary Completion Date
N/A
Phase
Phase 3
Study Type
Interventional
Enrollment
1000
Conditions
Intervention
Eligibility
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.
Gender
All
Minimum Age
19 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Michael Todd, M.D. |
Principal Investigator |
University of Iowa |
Location
Facility |
|
University of Iowa, Department of Anesthesia, 6505-5 John Colloton Pavilion Iowa City Iowa 52242 United States |
Location Countries
Country
United States
Verification Date
2003-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Keywords
Has Expanded Access
No
Condition Browse
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Primary Purpose
Treatment
Study First Submitted
January 8, 2002
Study First Submitted Qc
January 8, 2002
Study First Posted
January 9, 2002
Last Update Submitted
June 23, 2005
Last Update Submitted Qc
June 23, 2005
Last Update Posted
June 24, 2005
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.