Hypothermia and Hemostasis After Cardiac Arrest

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02258360
• Other study ID #: PROID7005
• Status: Active, not recruiting
• Phase: N/A
• First received: August 29, 2014
• Last updated: March 28, 2016
• Start date: February 2013
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coagulants
• Heart Arrest
• Hemostasis
• Hypothermia

Intervention

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

Locations

Country	Name	City	State
Denmark	Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	International normalized ratio		After 22 hours, 46 hours and 70 hours	Yes
Other	APTT (activated partial thromboplastin time) in seconds		After 22 hours, 46 hours and 70 hours	Yes
Other	Fibrinogen in mol/l		After 22 hours, 46 hours and 70 hours	Yes
Other	Antithrombin in 10^3 int.units/l		After 22 hours, 46 hours and 70 hours	Yes
Other	D-dimer in mg/l FEU		After 22 hours, 46 hours and 70 hours	Yes
Other	Trombine time in seconds		After 22 hours, 46 hours and 70 hours	Yes
Primary	Clotting time in seconds, EXTEM	Measured by thomboelastometry on the ROTEM®	After 46 hours	No
Primary	Area under the curve, COL-test	Platelet function will be measured using Multiplate®	After 46 hours	No
Secondary	Clotting time in seconds, EXTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours and 70 hours	No
Secondary	Clotting time in seconds, -INTEM, FIBTEM and HEPTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Area under the curve, COL-test	Platelet function will be measured using Multiplate®.	After 22 hours and 70 hours	No
Secondary	Area under the curve,- ADP, ASPI and TRAP-test.	Platelet function will be measured using Multiplate®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM	Measured by thomboelastometry on the ROTEM®.	After 22 hours, 46 hours and 70 hours	No
Secondary	Area under the curve, Clot stability test		After 22 hours, 46 hours and 70 hours	No
Secondary	Area under the curve, Thrombin generation		After 22 hours, 46 hours and 70 hours	No