Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— NABIS:HIIR  

Official title:

National Acute Brain Injury Study: Hypothermia IIR

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00178711
• Other study ID #: 5U01 NS043353-06
• Secondary ID: FDA-2014-109
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 13, 2014
• Start date: November 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

Description:

NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5)

2. Estimated or known age > 16 and < 45 years old

3. Time of Injury within 2.5hrs of arrival at hospital

Exclusion Criteria:

1. GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization

2. GCS = 3 AND bilaterally non-reactive pupils

3. Abbreviated Injury Score (AIS) > 4 for any body area except head

4. Positive abdominal ultrasound or CT scan

5. Persistent hypotension (systolic blood pressure < 110mmHGg)

6. Persistent hypoxia (O2 Saturation < 94%)

7. Positive pregnancy test

8. Injured greater than 2.5 hours from hospital arrival

9. Pre-existing medical conditions, if known

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hypothermia
• Traumatic Brain Injury

Intervention

Device:
• Hypothermia
Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours

Locations

Country	Name	City	State
Canada	University of Calgary Health Science Center : Foothills Medical Center	Calgary	Alberta
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	University of Texas Health Science Center, Memorial Hermann Hospital	Houston	Texas
United States	University of Pittsburgh : University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of St Louis : St. Louis University Hospital	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Clifton GL, Coffey CS, Fourwinds S, Zygun D, Valadka A, Smith KR Jr, Frisby ML, Bucholz RD, Wilde EA, Levin HS, Okonkwo DO. Early induction of hypothermia for evacuated intracranial hematomas: a post hoc analysis of two clinical trials. J Neurosurg. 2012 — View Citation

Clifton GL, Valadka A, Zygun D, Coffey CS, Drever P, Fourwinds S, Janis LS, Wilde E, Taylor P, Harshman K, Conley A, Puccio A, Levin HS, McCauley SR, Bucholz RD, Smith KR, Schmidt JH, Scott JN, Yonas H, Okonkwo DO. Very early hypothermia induction in pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glasgow Outcome Scale - Extended		0-12 months	No
Other	Disability Rating Scale		assessed 0-12 months	No
Other	Neurobehavioral Rating Scale - Revised		0-12 months	No
Other	Neurological Outcome Scale for Traumatic Brain Injury		0-12 months	No
Other	Symbol Digit Modalities Test		0-12 months	No
Other	Rey Osterrieth Complex Figure		0-12 months	No
Other	Verbal Selective Reminding Test Trails B		0-12 months	No
Other	Grooved Pegboard		0-12 months	No
Other	Controlled Oral Word Association Test		0-12 months	No
Primary	The Dichotomized Glasgow Outcome Scale	The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.	6 months with a window of plus or minus one month	No