Haemostasis and Therapeutic Hypothermia

Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?

Sponsors

Lead Sponsor: University of Aarhus

Source University of Aarhus
Brief Summary

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

Detailed 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.

Overall Status Completed
Start Date January 2014
Completion Date May 2015
Primary Completion Date August 2014
Study Type Observational
Primary Outcome
Measure Time Frame
To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached. 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Secondary Outcome
Measure Time Frame
To detect changes in the clot formation time (s), during the first 3 days after target temperature (34 °C) is reached. 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
To detect changes in maximum clot firmness (mm), during the first 3 days after target temperature (34 °C) is reached. 22, 46 and 70 hours after hypothermia is reached. (+/- 2 hours)
To detect changes in time to maximum velocity (s), during the first 3 days after target temperature (34 °C) is reached. 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
To detect changes in maximum velocity (mm/min.), during the first 3 days after target temperature (34 °C) is reached. 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Enrollment 26
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- age <18 years.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.
Location Countries

Denmark

Verification Date

June 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

Source: ClinicalTrials.gov