Overview

This trial is active, not recruiting.

Conditions hypothermia, heart arrest, hemostasis, coagulants
Treatment therapeutic hypothermia
Sponsor University of Aarhus
Start date February 2013
End date June 2015
Trial size 82 participants
Trial identifier NCT02258360, PROID7005

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Therapeutic hypothermia for 24 hours after reaching target temperature
therapeutic hypothermia
Therapeutic hypothermia with a target temperature between 32-34°C.
(Experimental)
Therapeutic hypothermia for 48 hours after reaching target temperature
therapeutic hypothermia
Therapeutic hypothermia with a target temperature between 32-34°C.

Primary Outcomes

Measure
Clotting time in seconds, EXTEM
time frame: After 46 hours
Area under the curve, COL-test
time frame: After 46 hours

Secondary Outcomes

Measure
Clotting time in seconds, EXTEM
time frame: After 22 hours and 70 hours
Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, COL-test
time frame: After 22 hours and 70 hours
Area under the curve,- ADP, ASPI and TRAP-test.
time frame: After 22 hours, 46 hours and 70 hours
Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, Clot stability test
time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, Thrombin generation
time frame: After 22 hours, 46 hours and 70 hours

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
Principal investigator Anni Norgaard Jeppesen, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.