Hypothermia and Hemostasis After Cardiac Arrest

Not Applicable

• Conditions: Hypothermia; Heart Arrest; Hemostasis; Coagulants
• Interventions: Other: Therapeutic hypothermia

• Registration Number: NCT02258360
• Lead Sponsor: University of Aarhus

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-07
• Primary Completion: 2015-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hours hypothermia	Therapeutic hypothermia	Therapeutic hypothermia for 24 hours after reaching target temperature
48 hours hypothermia	Therapeutic hypothermia	Therapeutic hypothermia for 48 hours after reaching target temperature

Primary Outcome Measures

Name	Time	Method
Clotting time in seconds, EXTEM	After 46 hours	Measured by thomboelastometry on the ROTEM®
Area under the curve, COL-test	After 46 hours	Platelet function will be measured using Multiplate®

Secondary Outcome Measures

Name	Time	Method
Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM	After 22 hours, 46 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM	After 22 hours, 46 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Area under the curve, COL-test	After 22 hours and 70 hours	Platelet function will be measured using Multiplate®.
Clotting time in seconds, EXTEM	After 22 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Clotting time in seconds, -INTEM, FIBTEM and HEPTEM	After 22 hours, 46 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM	After 22 hours, 46 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Area under the curve, Thrombin generation	After 22 hours, 46 hours and 70 hours
Area under the curve,- ADP, ASPI and TRAP-test.	After 22 hours, 46 hours and 70 hours	Platelet function will be measured using Multiplate®.
Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM	After 22 hours, 46 hours and 70 hours	Measured by thomboelastometry on the ROTEM®.
Area under the curve, Clot stability test	After 22 hours, 46 hours and 70 hours

Trial Locations

Locations (1)

Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Aarhus N, Denmark