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Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial (THAPCA-IH)

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ClinicalTrials.gov Identifier: NCT00880087
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Frank W. Moler, M.D, M.S, University of Michigan

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
Procedure: Therapeutic Normothermia

  Participant Flow

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 therapeutic 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   166 [1]   163 [2] 
COMPLETED   166 [3]   161 [4] 
NOT COMPLETED   0   2 
Lost to Follow-up                0                2 
[1] Among the 166 Started, 161 received Therapeutic Hypothermia and 5 received no treatment.
[2] Among the 163 Started, 160 received Therapeutic Normothermia and 3 received no treatment.
[3] 1-year vital status available for all 166 Started patients.
[4] Of 161 with 1-year vital status, 158 had received Therapeutic Normothermia, 3 received no treatment.



  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.
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 therapeutic 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]
 166   163   329 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 1.4 
 (0.3 to 5.7) 
 0.6 
 (0.2 to 6.3) 
 1.0 
 (0.2 to 5.8) 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age Category       
< 2 yr      97  58.4%      104  63.8%      201  61.1% 
2 - <12 yr      48  28.9%      35  21.5%      83  25.2% 
12 - 17 yr      21  12.7%      24  14.7%      45  13.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69  41.6%      64  39.3%      133  40.4% 
Male      97  58.4%      99  60.7%      196  59.6% 


  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 Who Survive)   [ Time Frame: Measured at Month 12 ]

5.  Other Pre-specified:   Neurological Abnormality Scores (for Participants Who Survive)   [ Time Frame: Measured at Month 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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: Dr. Rich Holubkov, Professor of Pediatrics
Organization: University of Utah
phone: 807-587-3326
e-mail: richard.holubkov@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: NCT00880087     History of Changes
Other Study ID Numbers: 620
U01HL094345 ( U.S. NIH Grant/Contract )
First Submitted: April 10, 2009
First Posted: April 13, 2009
Results First Submitted: March 20, 2018
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018