Haemostasis and Therapeutic Hypothermia

November 30, 2015 updated by: University of Aarhus

Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with mild therapeutic hypothermia for 24-48 hours due to cardiac arrest.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • age <18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached.
Time Frame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To detect changes in the clot formation time (s), during the first 3 days after target temperature (34 °C) is reached.
Time Frame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
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).
To detect changes in maximum clot firmness (mm), during the first 3 days after target temperature (34 °C) is reached.
Time Frame: 22, 46 and 70 hours after hypothermia is reached. (+/- 2 hours)
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)
To detect changes in time to maximum velocity (s), during the first 3 days after target temperature (34 °C) is reached.
Time Frame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
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).
To detect changes in maximum velocity (mm/min.), during the first 3 days after target temperature (34 °C) is reached.
Time Frame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Anne-Mette Hvas, PhD, University of Aarhus
  • Principal Investigator: Anne Katrine Wulff Nielsen, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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