Hypothermia During Intracranial Aneurysm Surgery Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aneurysm Hypothermia Subarachnoid Hemorrhage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

aneurysm hypothermia subarachnoid intracranial hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mild intraoperative hypothermia (33 degrees Celsius)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Todd, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Iowa, Department of Anesthesia, 6505-5 John Colloton Pavilion

Iowa City, Iowa, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Bayman EO, Chaloner KM, Hindman BJ, Todd MM; IHAST Investigators. Bayesian methods to determine performance differences and to quantify variability among centers in multi-center trials: the IHAST trial. BMC Med Res Methodol. 2013 Jan 16;13:5. doi: 10.1186/1471-2288-13-5.

Reference Type DERIVED

PMID: 23324207 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NS038554

Identifier Type: NIH

Identifier Source: org_study_id

View Link