TTH48: Time-differentiated Therapeutic Hypothermia

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01689077
• Collaborator: (none)
• Enrollment: 355
• Locations: 10
• Arms: 2
• Duration (Months): 48
• Patients Per Site: 35.5
• Patients Per Site Per Month: 0.7

Study Details

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	Phase
Out of Hospital Cardiac Arrest	Other: Therapeutic hypothermia	N/A

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
• 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: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

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 [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 [10 days]

   Adverse events are registered during the treatment and until discharge from primary hospital unit

2. CPC at discharge [3 month]

   CPC at discharge from primary hospital unit and after 28 days plus after 3 month

3. Mortality [6 month]

   CPC 5 at 6 month

Other Outcome Measures

1. GCS [28 days]

   Glasgow Coma Score at day 4 and at discharge from primary hospital unit

2. GCS progression [25 weeks]

   Glasgow Coma Score throughout the observation period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Intensive Care, Erasme Hospital	Brussels		Belgium	1070
2	Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg	Aalborg		Denmark	9000
3	Department og Anesthesiologi and Intensive Care Medicine,	Aarhus		Denmark	8200
4	Department of Cardiology, Copenhagen University Hospital, Rigshospitalet	Copenhagen		Denmark	2100
5	Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital	Odense		Denmark	5000
6	Anaesthesiology Clinic, North Estonia Medical Centre	Tallinn		Estonia	13419
7	Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital	Helsinki		Finland	00029-HUS
8	Hospital District of Southwest Finland), Kiinamyllynkatu	Turku		Finland
9	Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin	Berlin		Germany
10	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01689077
• Other Study ID Numbers: TTH48
• First Posted: Sep 20, 2012
• Last Update Posted: Jan 18, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Hypothermia

Study Results

No Results Posted as of Jan 18, 2017