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Trial record 2 of 2 for:    THAPCA

Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial (THAPCA-OH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878644
First Posted: April 9, 2009
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank W. Moler, M.D, M.S, University of Michigan
Results First Submitted: May 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cardiac Arrest
Interventions: Procedure: Therapeutic Hypothermia
Other: Therapeutic Normothermia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Therapeutic Hypothermia

Participants will receive therapeutic hypothermia after experiencing cardiac arrest.

Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.

Therapeutic Normothermia

Participants will receive therapeutic normothermia after experiencing cardiac arrest.

Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.


Participant Flow:   Overall Study
    Therapeutic Hypothermia   Therapeutic Normothermia
STARTED   155   140 
COMPLETED   151   136 
NOT COMPLETED   4   4 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Therapeutic Hypothermia

Participants will receive therapeutic hypothermia after experiencing cardiac arrest.

Therapeutic Hypothermia: Participants who are assigned to receive hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32 to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36 to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.

Therapeutic Normothermia

Participants will receive therapeutic normothermia after experiencing cardiac arrest.

Therapeutic Normothermia: Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.

Total Total of all reporting groups

Baseline Measures
   Therapeutic Hypothermia   Therapeutic Normothermia   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   140   295 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 2.1 
 (0.6 to 10.1) 
 1.6 
 (0.4 to 7.0) 
 2.0 
 (0.5 to 8.7) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age Category       
< 2 yr      76  49.0%      73  52.1%      149  50.5% 
2 - <12 yr      48  31.0%      45  32.1%      93  31.5% 
12 - 17 yr      31  20.0%      22  15.7%      53  18.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      53  34.2%      46  32.9%      99  33.6% 
Male      102  65.8%      94  67.1%      196  66.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival With Good Neurobehavioral Outcome   [ Time Frame: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. ]

2.  Secondary:   Survival   [ Time Frame: Measured at one-year anniversary of cardiac arrest. ]

3.  Secondary:   Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest   [ Time Frame: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. ]

4.  Secondary:   Neuropsychological Scores (for Participants That Survive)   [ Time Frame: Measured at Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Marianne Gildea, BSN, MS; Director of THAPCA Trials
Organization: University of Utah
phone: 801-608-4907
e-mail: marianne.gildea@hsc.utah.edu


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Frank W. Moler, M.D, M.S, University of Michigan
ClinicalTrials.gov Identifier: NCT00878644     History of Changes
Other Study ID Numbers: 619
U01HL094339 ( U.S. NIH Grant/Contract )
First Submitted: April 8, 2009
First Posted: April 9, 2009
Results First Submitted: May 24, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017