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Hypothermia and Hemostasis After Cardiac Arrest

University of Aarhus logo

University of Aarhus

Status

Unknown

Conditions

Hemostasis
Heart Arrest
Coagulants
Hypothermia

Treatments

Other: Therapeutic hypothermia

Study type

Interventional

Funder types

Other

Identifiers

NCT02258360
PROID7005

Details and patient eligibility

About

This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest.

The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia

Our specific aims are:

  • To investigate the whole blood coagulation using the rotational thromboelastometry.
  • To investigate the function of platelets

Enrollment

82 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Out of hospital cardiac arrest of presumed cardiac cause
  • Return of spontaneous circulation (ROSC)
  • Glasgow Coma Score < 8
  • Age > 18 years and < 80 years

Exclusion criteria

  • > 60 minutes from the circulatory collapse to ROSC
  • Time interval > 4 hours from cardiac arrest to initiation of therapeutic hypothermia
  • Terminal illness
  • Coagulation disorder
  • Unwitnessed asystolia
  • Cerebral performance category 3-4 before the cardiac arrest
  • Severe persistent cardiogenic shock
  • Pregnancy
  • Persistent cardiogenic shock (systolic blood pressure < 80 despite inotropic treatment)
  • New apoplexy or intracerebral hemorrhage
  • Lack of consent from the relatives
  • Lack of consent from the GP
  • Lack of consent from the patient if he/she wakes up and is relevant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

24 hours hypothermia
Active Comparator group
Description:
Therapeutic hypothermia for 24 hours after reaching target temperature
Treatment:
Other: Therapeutic hypothermia
48 hours hypothermia
Experimental group
Description:
Therapeutic hypothermia for 48 hours after reaching target temperature
Treatment:
Other: Therapeutic hypothermia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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