Clinical trial NCT02179021: Haemostasis and Therapeutic Hypothermia
Official title: Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia
Heart Arrest
Keywords: Thromboelastometry
Haemostasis
Hypothermia
Heart arrest
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with mild therapeutic hypothermia for 24-48 hours due to cardiac arrest.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age \<18 years.

Primary outcomes:
measure: To detect changes in clotting time in seconds (s), during the first 3 days after target temperature (34 °C) is reached.
timeFrame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Secondary outcomes:
measure: To detect changes in the clot formation time (s), during the first 3 days after target temperature (34 °C) is reached.
timeFrame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
measure: To detect changes in maximum clot firmness (mm), during the first 3 days after target temperature (34 °C) is reached.
timeFrame: 22, 46 and 70 hours after hypothermia is reached. (+/- 2 hours)
measure: To detect changes in time to maximum velocity (s), during the first 3 days after target temperature (34 °C) is reached.
timeFrame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
measure: To detect changes in maximum velocity (mm/min.), during the first 3 days after target temperature (34 °C) is reached.
timeFrame: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.
Study officials:
affiliation: University of Aarhus
name: Anne-Mette Hvas, PhD
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Anne Katrine Wulff Nielsen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.