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Completed

NCT Number: NCT02179021

Haemostasis and 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.

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Key information

Conditions

Hypothermia Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • age <18 years.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jul 1, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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