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Time-differentiated Therapeutic Hypothermia (TTH48)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Aarhus
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: September 17, 2012
Last updated: March 28, 2016
Last verified: September 2012
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 Intervention
Out of Hospital Cardiac Arrest
Other: Therapeutic hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • CPC [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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:
  • Adverse events [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Adverse events are registered during the treatment and until discharge from primary hospital unit

  • CPC at discharge [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    CPC at discharge from primary hospital unit and after 28 days plus after 3 month

  • Mortality [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    CPC 5 at 6 month

Other Outcome Measures:
  • GCS [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Glasgow Coma Score at day 4 and at discharge from primary hospital unit

  • GCS progression [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
    Glasgow Coma Score throughout the observation period

Estimated Enrollment: 340
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01689077

Contact: Hans Kirkegaard, Professor 004528149787

Department of Intensive Care, Erasme Hospital Recruiting
Brussels, Belgium, 1070
Contact: Fabio S Taccone, MD         
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg Recruiting
Aalborg, Denmark, 9000
Contact: Inge De Haas, MD    004599328588   
Principal Investigator: Inge De Haas, MD         
Department og Anesthesiologi and Intensive Care Medicine, Recruiting
Aarhus, Denmark, 8200
Contact: Hans Kirkegaard, Professor    004528149783   
Contact: Susanne Ilkjaer, MD, PhD         
Principal Investigator: Susanne Ilkjaer, MD, PhD         
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet Active, not recruiting
Copenhagen, Denmark, 2100
Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital Active, not recruiting
Odense, Denmark, 5000
Anaesthesiology Clinic, North Estonia Medical Centre Recruiting
Tallinn, Estonia, 13419
Contact: Valdo Toome, MD   
Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029-HUS
Contact: Markus Skrifvars, MD   
Hospital District of Southwest Finland), Kiinamyllynkatu Recruiting
Turku, Finland
Contact: Timo Laitio   
Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Christian Storm, MD, Ph.D   
Anesthesiology and Critical Care, Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Eldar Søreide, Professor   
Sponsors and Collaborators
University of Aarhus
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 Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01689077     History of Changes
Other Study ID Numbers: TTH48 
Study First Received: September 17, 2012
Last Updated: March 28, 2016
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Body Temperature Changes
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases processed this record on October 25, 2016