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Hypothermia and Hemostasis After Cardiac Arrest

Primary Purpose

Hypothermia, Heart Arrest, Hemostasis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Therapeutic hypothermia
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

24 hours hypothermia

48 hours hypothermia

Arm Description

Therapeutic hypothermia for 24 hours after reaching target temperature

Therapeutic hypothermia for 48 hours after reaching target temperature

Outcomes

Primary Outcome Measures

Clotting time in seconds, EXTEM
Measured by thomboelastometry on the ROTEM®
Area under the curve, COL-test
Platelet function will be measured using Multiplate®

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2014
Last Updated
March 28, 2016
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02258360
Brief Title
Hypothermia and Hemostasis After Cardiac Arrest
Official Title
The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Heart Arrest, Hemostasis, Coagulants
Keywords
Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24 hours hypothermia
Arm Type
Active Comparator
Arm Description
Therapeutic hypothermia for 24 hours after reaching target temperature
Arm Title
48 hours hypothermia
Arm Type
Experimental
Arm Description
Therapeutic hypothermia for 48 hours after reaching target temperature
Intervention Type
Other
Intervention Name(s)
Therapeutic hypothermia
Intervention Description
Therapeutic hypothermia with a target temperature between 32-34°C.
Primary Outcome Measure Information:
Title
Clotting time in seconds, EXTEM
Description
Measured by thomboelastometry on the ROTEM®
Time Frame
After 46 hours
Title
Area under the curve, COL-test
Description
Platelet function will be measured using Multiplate®
Time Frame
After 46 hours
Secondary Outcome Measure Information:
Title
Clotting time in seconds, EXTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours and 70 hours
Title
Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Area under the curve, COL-test
Description
Platelet function will be measured using Multiplate®.
Time Frame
After 22 hours and 70 hours
Title
Area under the curve,- ADP, ASPI and TRAP-test.
Description
Platelet function will be measured using Multiplate®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
Description
Measured by thomboelastometry on the ROTEM®.
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Area under the curve, Clot stability test
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Area under the curve, Thrombin generation
Time Frame
After 22 hours, 46 hours and 70 hours
Other Pre-specified Outcome Measures:
Title
International normalized ratio
Time Frame
After 22 hours, 46 hours and 70 hours
Title
APTT (activated partial thromboplastin time) in seconds
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Fibrinogen in mol/l
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Antithrombin in 10^3 int.units/l
Time Frame
After 22 hours, 46 hours and 70 hours
Title
D-dimer in mg/l FEU
Time Frame
After 22 hours, 46 hours and 70 hours
Title
Trombine time in seconds
Time Frame
After 22 hours, 46 hours and 70 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anni Norgaard Jeppesen, MD
Organizational Affiliation
Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28602694
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.
Results Reference
derived

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Hypothermia and Hemostasis After Cardiac Arrest

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