NCT01689077

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

December 1, 2016

Enrollment Period

4 years

First QC Date

September 17, 2012

Last Update Submit

January 17, 2017

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • CPC

    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.

    6 month

Secondary Outcomes (3)

  • Adverse events

    10 days

  • CPC at discharge

    3 month

  • Mortality

    6 month

Other Outcomes (2)

  • GCS

    28 days

  • GCS progression

    25 weeks

Study Arms (2)

24 hours hypothermia

ACTIVE COMPARATOR

24 hours hypothermia

Other: Therapeutic hypothermia

48 hours hypothermoa

EXPERIMENTAL

48 hours hypothermia

Other: Therapeutic hypothermia

Interventions

Therapeutic hypothermiaOTHER

Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours

24 hours hypothermia48 hours hypothermoa

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Out of hospital cardiac arrest of suspected cardiac origin
  • Return of spontaneous circulation (ROSC)
  • Glasgow Coma Score \< 8
  • Estimated time interval from cardiac arrest to ROSC ≤ 60 min

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Intensive Care, Erasme Hospital

Brussels, 1070, Belgium

Location

Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg

Aalborg, 9000, Denmark

Location

Department og Anesthesiologi and Intensive Care Medicine,

Aarhus, 8200, Denmark

Location

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital

Odense, 5000, Denmark

Location

Anaesthesiology Clinic, North Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital

Helsinki, 00029-HUS, Finland

Location

Hospital District of Southwest Finland), Kiinamyllynkatu

Turku, Finland

Location

Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin

Berlin, Germany

Location

Anesthesiology and Critical Care, Stavanger University Hospital

Stavanger, 4068, Norway

Location

Related Publications (9)

  • Evald L, Skrifvars MB, Virta JJ, Tiainen M, Laitio T, Leithner C, Soreide E, Hassager C, Rasmussen B, Grejs AM, Jeppesen AN, Kirkegaard H, Nielsen JF. Long-term functional outcome and quality of life 5-8 years after out of hospital cardiac arrest. Resuscitation. 2025 Oct;215:110672. doi: 10.1016/j.resuscitation.2025.110672. Epub 2025 Jun 9.

    PMID: 40499675DERIVED

  • Larsen AI, Grejs AM, Vistisen ST, Strand K, Skadberg O, Jeppesen AN, Duez CHV, Kirkegaard H, Soreide E. Kinetics of 2 different high-sensitive troponins during targeted temperature management in out-of-hospital cardiac arrest patients with acute myocardial infarction: a post hoc sub-study of a randomised clinical trial. BMC Cardiovasc Disord. 2022 Jul 30;22(1):342. doi: 10.1186/s12872-022-02778-4.

    PMID: 35907787DERIVED

  • Bach HM, Duez CHV, Jeppesen AN, Strand K, Soreide E, Kirkegaard H, Grejs AM. MR-proANP and NT-proBNP During Targeted Temperature Management Following Out-of-Hospital Cardiac Arrest: A Post hoc Analysis of the TTH48 Trial. Ther Hypothermia Temp Manag. 2022 Jun;12(2):82-89. doi: 10.1089/ther.2021.0012. Epub 2021 Aug 10.

    PMID: 34375135DERIVED

  • Hastbacka J, Kirkegaard H, Soreide E, Taccone FS, Rasmussen BS, Storm C, Kjaergaard J, Laitio T, Duez CHV, Jeppesen AN, Grejs AM, Skrifvars MB. Severe or critical hypotension during post cardiac arrest care is associated with factors available on admission - a post hoc analysis of the TTH48 trial. J Crit Care. 2021 Feb;61:186-190. doi: 10.1016/j.jcrc.2020.10.026. Epub 2020 Nov 2.

    PMID: 33181415DERIVED

  • Skrifvars MB, Soreide E, Sawyer KN, Taccone FS, Toome V, Storm C, Jeppesen A, Grejs A, Duez CHV, Tiainen M, Rasmussen BS, Laitio T, Hassager C, Kirkegaard H. Hypothermic to ischemic ratio and mortality in post-cardiac arrest patients. Acta Anaesthesiol Scand. 2020 Apr;64(4):546-555. doi: 10.1111/aas.13528. Epub 2019 Dec 26.

    PMID: 31830304DERIVED

  • Evald L, Bronnick K, Duez CHV, Grejs AM, Jeppesen AN, Soreide E, Kirkegaard H, Nielsen JF. Prolonged targeted temperature management reduces memory retrieval deficits six months post-cardiac arrest: A randomised controlled trial. Resuscitation. 2019 Jan;134:1-9. doi: 10.1016/j.resuscitation.2018.12.002. Epub 2018 Dec 17.

    PMID: 30572070DERIVED

  • Kirkegaard H, Soreide E, de Haas I, Pettila V, Taccone FS, Arus U, Storm C, Hassager C, Nielsen JF, Sorensen CA, Ilkjaer S, Jeppesen AN, Grejs AM, Duez CHV, Hjort J, Larsen AI, Toome V, Tiainen M, Hastbacka J, Laitio T, Skrifvars MB. Targeted Temperature Management for 48 vs 24 Hours and Neurologic Outcome After Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2017 Jul 25;318(4):341-350. doi: 10.1001/jama.2017.8978.

    PMID: 28742911DERIVED

  • Kirkegaard H, Pedersen AR, Pettila V, Hjort J, Rasmussen BS, de Haas I, Nielsen JF, Ilkjaer S, Kaltoft A, Jeppesen AN, Grejs AM, Duez CH, Larsen AI, Toome V, Arus U, Taccone FS, Storm C, Laitio T, Skrifvars MB, Soreide E. A statistical analysis protocol for the time-differentiated target temperature management after out-of-hospital cardiac arrest (TTH48) clinical trial. Scand J Trauma Resusc Emerg Med. 2016 Nov 28;24(1):138. doi: 10.1186/s13049-016-0334-0.

    PMID: 27894327DERIVED

  • Kirkegaard H, Rasmussen BS, de Haas I, Nielsen JF, Ilkjaer S, Kaltoft A, Jeppesen AN, Grejs A, Duez CH, Larsen AI, Pettila V, Toome V, Arus U, Taccone FS, Storm C, Skrifvars MB, Soreide E. Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial. Trials. 2016 May 4;17(1):228. doi: 10.1186/s13063-016-1338-9.

    PMID: 27142588DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CryotherapyTherapeutics

Study Officials

  • Hans Kirkegaard, Professor

    Department of Anaesthesia and Intensive care medicine, Aarhus University Hosptal, Brendstrupgaardsvej 8200 Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 20, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 18, 2017

Record last verified: 2016-12

Locations

BE(1)NO(1)FI(2)DK(4)ES(1)DE(1)