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Haemostasis and Therapeutic Hypothermia

NCT ID: NCT02179021

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Hypothermia Heart Arrest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \<18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Mette Hvas, PhD

Role: STUDY_DIRECTOR

University of Aarhus

Anne Katrine Wulff Nielsen

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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

Aarhus N, , Denmark

Site Status

Countries

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Denmark

References

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Nielsen AK, Jeppesen AN, Kirkegaard H, Hvas AM. Changes in coagulation during therapeutic hypothermia in cardiac arrest patients. Resuscitation. 2016 Jan;98:85-90. doi: 10.1016/j.resuscitation.2015.11.007. Epub 2015 Nov 22.

Reference Type DERIVED
PMID: 26593973 (View on PubMed)

Other Identifiers

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2011-0022

Identifier Type: -

Identifier Source: org_study_id