Clinical trial NCT02258360: Hypothermia and Hemostasis After Cardiac Arrest
Official title: The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia
Heart Arrest
Hemostasis
Coagulants
Keywords: Thromboelastometry
Haemostasis
Hypothermia
Heart Arrest
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Clotting time in seconds, EXTEM
timeFrame: After 46 hours
measure: Area under the curve, COL-test
timeFrame: After 46 hours
Secondary outcomes:
measure: Clotting time in seconds, EXTEM
timeFrame: After 22 hours and 70 hours
measure: Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Area under the curve, COL-test
timeFrame: After 22 hours and 70 hours
measure: Area under the curve,- ADP, ASPI and TRAP-test.
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Area under the curve, Clot stability test
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Area under the curve, Thrombin generation
timeFrame: After 22 hours, 46 hours and 70 hours
Other outcomes:
measure: International normalized ratio
timeFrame: After 22 hours, 46 hours and 70 hours
measure: APTT (activated partial thromboplastin time) in seconds
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Fibrinogen in mol/l
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Antithrombin in 10^3 int.units/l
timeFrame: After 22 hours, 46 hours and 70 hours
measure: D-dimer in mg/l FEU
timeFrame: After 22 hours, 46 hours and 70 hours
measure: Trombine time in seconds
timeFrame: After 22 hours, 46 hours and 70 hours
Locations:
city: Aarhus
country: Denmark
facility: Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby
state: Aarhus N
Study officials:
affiliation: Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine
name: Anni Norgaard Jeppesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeppesen AN, Hvas AM, Duez CHV, Grejs AM, Ilkjaer S, Kirkegaard H. Prolonged targeted temperature management compromises thrombin generation: A randomised clinical trial. Resuscitation. 2017 Sep;118:126-132. doi: 10.1016/j.resuscitation.2017.06.004. Epub 2017 Jun 7.