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Time-differentiated Therapeutic Hypothermia (TTH48)

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ClinicalTrials.gov Identifier: NCT01689077
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

Condition or disease Intervention/treatment
Out of Hospital Cardiac Arrest Other: Therapeutic hypothermia

Detailed Description:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.
Study Start Date : January 2013
Primary Completion Date : January 2017
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 24 hours hypothermia
24 hours hypothermia
Other: Therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
Experimental: 48 hours hypothermoa
48 hours hypothermia
Other: Therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours


Outcome Measures

Primary Outcome Measures :
  1. CPC [ Time Frame: 6 month ]
    CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 10 days ]
    Adverse events are registered during the treatment and until discharge from primary hospital unit

  2. CPC at discharge [ Time Frame: 3 month ]
    CPC at discharge from primary hospital unit and after 28 days plus after 3 month

  3. Mortality [ Time Frame: 6 month ]
    CPC 5 at 6 month


Other Outcome Measures:
  1. GCS [ Time Frame: 28 days ]
    Glasgow Coma Score at day 4 and at discharge from primary hospital unit

  2. GCS progression [ Time Frame: 25 weeks ]
    Glasgow Coma Score throughout the observation period


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Out of hospital cardiac arrest of suspected cardiac origin
  2. Return of spontaneous circulation (ROSC)
  3. Glasgow Coma Score < 8
  4. Estimated time interval from cardiac arrest to ROSC ≤ 60 min

Exclusion Criteria:

  1. OOH-CA of suspected origin other than cardiac
  2. In hospital Cardiac arrest
  3. Terminal disease
  4. Coagulation disorders
  5. Unwitnessed asystolia
  6. Time from cardiac arrest to start of hypothermia treatment > 240 min
  7. GCS ≥ 8
  8. Pregnancy
  9. Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump).
  10. CPC 3-4 before cardiac arrest
  11. Acute intra cerebral bleeding
  12. Acute stroke
  13. Acute coronary artery bypass grafting
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689077


Locations
Belgium
Department of Intensive Care, Erasme Hospital
Brussels, Belgium, 1070
Denmark
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg
Aalborg, Denmark, 9000
Department og Anesthesiologi and Intensive Care Medicine,
Aarhus, Denmark, 8200
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital
Odense, Denmark, 5000
Estonia
Anaesthesiology Clinic, North Estonia Medical Centre
Tallinn, Estonia, 13419
Finland
Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
Helsinki, Finland, 00029-HUS
Hospital District of Southwest Finland), Kiinamyllynkatu
Turku, Finland
Germany
Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin
Berlin, Germany
Norway
Anesthesiology and Critical Care, Stavanger University Hospital
Stavanger, Norway, 4068
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Hans Kirkegaard, Professor Department of Anaesthesia and Intensive care medicine, Aarhus University Hosptal, Brendstrupgaardsvej 8200 Aarhus, Denmark
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01689077     History of Changes
Other Study ID Numbers: TTH48
First Posted: September 20, 2012    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms