Haemostasis and Therapeutic Hypothermia
Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?
1 other identifier
observational
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedDecember 2, 2015
June 1, 2014
7 months
June 12, 2014
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (4)
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).
Eligibility Criteria
Patients treated with mild therapeutic hypothermia for 24-48 hours due to cardiac arrest.
You may qualify if:
- Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.
You may not qualify if:
- age \<18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.
Aarhus N, 8200, Denmark
Related Publications (1)
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.
PMID: 26593973DERIVED
Biospecimen
Whole blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne-Mette Hvas, PhD
University of Aarhus
- PRINCIPAL INVESTIGATOR
Anne Katrine Wulff Nielsen
University of Aarhus
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
July 1, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
May 1, 2015
Last Updated
December 2, 2015
Record last verified: 2014-06