Hypothermia and Hemostasis After Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-06-30

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

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Detailed Description

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Conditions

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Hypothermia Heart Arrest Hemostasis Coagulants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24 hours hypothermia

Therapeutic hypothermia for 24 hours after reaching target temperature

Group Type ACTIVE_COMPARATOR

Therapeutic hypothermia

Intervention Type OTHER

Therapeutic hypothermia with a target temperature between 32-34°C.

48 hours hypothermia

Therapeutic hypothermia for 48 hours after reaching target temperature

Group Type EXPERIMENTAL

Therapeutic hypothermia

Intervention Type OTHER

Therapeutic hypothermia with a target temperature between 32-34°C.

Interventions

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Therapeutic hypothermia

Therapeutic hypothermia with a target temperature between 32-34°C.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No