HypothermiaNCT02179021
Haemostasis and Therapeutic Hypothermia
An observational study of Hypothermia and Heart Arrest, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest patients during therapeutic hypothermia compared with normothermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Heart Arrest
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with mild therapeutic hypothermia for 24-48 hours due to cardiac arrest.
Who may be able to join
- Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.
Who cannot join
- age <18 years.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Clinical Biochemistry and Dept of Anethesiology and Intensive Care.
Aarhus N, 8200
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypothermia, Heart Arrest
- Keywords
- Thromboelastometry, Haemostasis, Hypothermia, Heart arrest
- Medical subject headings
- Hypothermia, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.
Measured: 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.
Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.
Measured: 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.
Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.
Measured: 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.
Coagulation parameters will be measured by thromboelastometry on the ROTEM® using a low-tissue-factor assay.
Measured: 22, 46 and 70 hours after target temperature (34 °C) is reached (+/- 2 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Mette Hvas, PhD, Study director, University of AarhusAnne Katrine Wulff Nielsen, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179021
- Sponsor's protocol ID
- 2011-0022
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26593973
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Haemostasis Impaired in Cardiac Arrest Patients During Therapeutic Hypothermia?
- ClinicalTrials.gov ID
- NCT02179021
- Acronym / sponsor ID
- 2011-0022
- Conditions
- Hypothermia, Heart Arrest
- Keywords
- Thromboelastometry, Haemostasis, Hypothermia, Heart arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with mild therapeutic hypothermia for 24-48 hours due to cardiac arrest.
Key inclusion criteria (1 listed)
- Treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest.
Key exclusion criteria (1 listed)
- age <18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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).
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)
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 26593973Nielsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Mette Hvas, PhD study director
University of Aarhus
Anne Katrine Wulff Nielsen principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia and Heart Arrest, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02179021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.