Hypothermia and Hemostasis After Cardiac Arrest

University of Aarhus82 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypothermia Heart Arrest Hemostasis Coagulants

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clotting time in seconds, EXTEM

Measured by thomboelastometry on the ROTEM®

Time frame: After 46 hours

Area under the curve, COL-test

Platelet function will be measured using Multiplate®

Time frame: After 46 hours

Secondary Outcomes

Clotting time in seconds, EXTEM

Measured by thomboelastometry on the ROTEM®.

Time frame: After 22 hours and 70 hours

Clotting time in seconds, -INTEM, FIBTEM and HEPTEM

Measured by thomboelastometry on the ROTEM®.