NCT00029133

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2002

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2003

First QC Date

January 8, 2002

Last Update Submit

June 23, 2005

Conditions

AneurysmHypothermiaSubarachnoid Hemorrhage

Keywords

aneurysmhypothermiasubarachnoid intracranial hemorrhage

Interventions

mild intraoperative hypothermia (33 degrees Celsius)PROCEDURE

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

    PMID: 23324207DERIVED

MeSH Terms

Conditions

AneurysmHypothermiaSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic Processes

Study Officials

  • Michael Todd, M.D.

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 8, 2002

First Posted

January 9, 2002

Study Start

February 1, 2000

Last Updated

June 24, 2005

Record last verified: 2003-08

Locations

US(1)