Haemostasis and Therapeutic Hypothermia

Hypothermia Clinical Trial

Official title:

Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179021
• Other study ID #: 2011-0022
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: November 30, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest patients during therapeutic hypothermia compared with normothermia.

Description:

Treatment with mild therapeutic hypothermia, 32-34 °C for 12-24 hours, has shown to improve the neurologic outcome in comatose survivors of out-of-hospital cardiac arrest. Hypothermia is suspected to inhibit haemostasis and therefore cardiac arrest patients with a risk of bleeding are not treated with therapeutic hypothermia. However, the impact on the coagulation system during mild therapeutic hypothermia, has not yet been fully investigated.

The investigators aim to investigate if mild therapeutic hypothermia influences haemostasis. We are including survivors of cardiac arrest, who are treated with hypothermia for 24-48 hours.

Blood will be sampled during hypothermia and secondly during normothermia. 30 minutes after the blood are sampled it will be analyzed using a sensitive low-tissue-factor assay with rotational thromboelastometry (ROTEM®). All the dynamic coagulation parameters obtained on the ROTEM® at hypothermia and normothermia, respectively, will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.

Exclusion Criteria:

• age <18 years.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.	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
Primary	To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached.	Clotting time will be measured by thromboelastometry on the ROTEM-analyzer using a low-tissue-factor assay.	22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).	No
Secondary	To detect changes in the clot formation time (s), during the first 3 days after target temperature (34 °C) is reached.	Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.	22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).	No
Secondary	To detect changes in maximum clot firmness (mm), during the first 3 days after target temperature (34 °C) is reached.	Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.	22, 46 and 70 hours after hypothermia is reached. (+/- 2 hours)	No
Secondary	To detect changes in time to maximum velocity (s), during the first 3 days after target temperature (34 °C) is reached.	Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.	22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).	No
Secondary	To detect changes in maximum velocity (mm/min.), during the first 3 days after target temperature (34 °C) is reached.	Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.	22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).	No