NCT02258360UnknownNot Applicable
The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Aarhus
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Clotting time in seconds, EXTEM
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Time Frame: After 46 hours
Measured by thomboelastometry on the ROTEM®
Area under the curve, COL-test
Time Frame: After 46 hours
Platelet function will be measured using Multiplate®
Secondary Outcomes
- Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Area under the curve, COL-test(After 22 hours and 70 hours)
- Clotting time in seconds, EXTEM(After 22 hours and 70 hours)
- Clotting time in seconds, -INTEM, FIBTEM and HEPTEM(After 22 hours, 46 hours and 70 hours)
- Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM(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)
- Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM(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)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
The Cardiac Effects of Prolonged Hypothermia After Cardiac ArrestHypothermiaCardiac ArrestNCT02066753University of Aarhus100
Completed
Not Applicable
Effect of Therapeutic hypothermia on myocardial function in term neonates with perinatal asphyxiaCTRI/2016/09/007257Dr Vishnubhat120
Completed
Not Applicable
Time-differentiated Therapeutic HypothermiaOut of Hospital Cardiac ArrestNCT01689077University of Aarhus355
Completed
Not Applicable
Hypothermia After Cardiac Arrest - Effects on Myocardial Function and Inflammatory Response.Out of Hospital Cardiac ArrestInflammatory ResponseIschemia Reperfusion InjuryHypothermiaNCT03743584Oslo University Hospital26
Not yet recruiting
Not Applicable
Beneficial Effect of Hypothermia Plus Hemicraniectomy Compared With HemicraniectomyHypothermiaNCT04825418Seoul National University Hospital35