Hypothermia and Hemostasis After Cardiac Arrest

Study Overview
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Brief Summary
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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

Official Title
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The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.

Conditions
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Hypothermia, Heart Arrest, Hemostasis, Coagulants

Intervention / Treatment
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* Other: Therapeutic hypothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 hours hypothermia<br>Therapeutic hypothermia for 24 hours after reaching target temperature | Other: Therapeutic hypothermia<br>* Therapeutic hypothermia with a target temperature between 32-34°C.<br>|
| Experimental: 48 hours hypothermia<br>Therapeutic hypothermia for 48 hours after reaching target temperature | Other: Therapeutic hypothermia<br>* Therapeutic hypothermia with a target temperature between 32-34°C.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest