Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR)

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Guy Clifton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178711
First received: September 13, 2005
Last updated: September 13, 2014
Last verified: September 2014
Results First Received: July 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Traumatic Brain Injury
Intervention: Device: Hypothermia

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
hypothermia group-- 26 ± 9 years of age, 40 males/12 females normothermia group--31 ± 11 year of age, 41 males/4 females

Reporting Groups
  Description
Hypothermia

Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.

Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours

Control Treated at normothermia
Total Total of all reporting groups

Baseline Measures
    Hypothermia     Control     Total  
Number of Participants  
[units: participants]
  52     45     97  
Age  
[units: years]
Mean ± Standard Deviation
  26  ± 9     31  ± 11     28  ± 10  
Age  
[units: participants]
     
<=18 years     7     6     13  
Between 18 and 65 years     45     38     83  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     12     4     16  
Male     40     41     81  



  Outcome Measures

1.  Primary:   The Dichotomized Glasgow Outcome Scale   [ Time Frame: 6 months with a window of plus or minus one month ]

2.  Other Pre-specified:   Glasgow Outcome Scale - Extended   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Other Pre-specified:   Disability Rating Scale   [ Time Frame: assessed 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Neurobehavioral Rating Scale – Revised   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Neurological Outcome Scale for Traumatic Brain Injury   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Other Pre-specified:   Symbol Digit Modalities Test   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Other Pre-specified:   Rey Osterrieth Complex Figure   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Other Pre-specified:   Verbal Selective Reminding Test Trails B   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Other Pre-specified:   Grooved Pegboard   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Other Pre-specified:   Controlled Oral Word Association Test   [ Time Frame: 0-12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination for futility.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Guy L Clifton
Organization: University of Texas Health Science Center
phone: 2024224824
e-mail: guy@guyclifton.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Guy Clifton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178711     History of Changes
Other Study ID Numbers: 5U01 NS043353-06, FDA-2014-109
Study First Received: September 13, 2005
Results First Received: July 31, 2014
Last Updated: September 13, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration