Funding Agency:

National Institutes of Health (Subcontract from University of Texas Health Science Center at Houston, Grant No. 5 U01 NS043353)

Total Project Period:

4/1/02 - 6/30/08

Total Project Award:

$635,000 to University of Pittsburgh

Principal Investigator:

Guy L. Clifton, MD (University of Texas Health Science Center at Houston)

Co-Investigators:

Alex Valadka, MD (The University of Texas Houston Health Science Center); David Zygun, MD (University of Calgary Health Science Center); John Schmidt, III, MD (Charleston Area Medical Center); Howard Yonas, MD (University of New Mexico); Kenneth R. Smith, Jr., MD (St. Louis University); David Okonkwo, MD, PhD

Project Summary:

This is a prospective trial based on the findings of NABIS:H I, a randomized, prospective, multi-center trial with specific aim to determine if surface-induced moderate hypothermia (33°C), begun within six hours of severe brain injury (Glasgow Coma Score, GCS, < 8) and maintained for 48 hours, would improve outcome with low toxicity.

Patients were randomized at 4.2+ 1.1 after injury and cooling was then begun. There was no difference in outcome, with 57% of both groups showing a poor outcome. Other findings were that treatment with hypothermia blunted major elevations of intracranial pressure. Also found was a significant treatment effect when therapeutic hypothermia was applied to patients who arrived at the study center with a low body temperature (< 35°C).

The specific aim of NABIS:H IIR is to determine if surface-induced moderate hypothermia (33°C for 48 hours) reached within four hours after severe brain injury improves outcome with low toxicity in patients age 16 – 45 years and a low admission temperature (< 35.0°C).

NABIS:H IIR has added a secondary hypothesis that patients who reach 35 degrees within 2 hours of injury will have improved outcomes compared to those who reach 35 degrees later than 2 hours.

Patients may enter the study in one of 2 ways;

1. randomization in the field by EMS personnel in helicopters staffed by personnel trained by study centers
2. randomization upon arrival to the emergency department of the study hospital within 2 hours of injury.

Currently at UPMC enrollment occurs in the emergency department. Pending completion of community consultation and IRB aproval enrollment will begin thrus EMS system utilizing STAT Medevac helicopters serving the counties of Armstrong, Butler, Westmoreland and Mahoning Co. Ohio.