HypothermiaNCT02258360
Hypothermia and Hemostasis After Cardiac Arrest
A study testing Therapeutic hypothermia in people with Hypothermia and Heart Arrest, run by University of Aarhus at 1 site in Denmark.
Trial summary
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothermia, Heart Arrest, Hemostasis
- What is being tested?
- Therapeutic hypothermia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jun 2017
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out of hospital cardiac arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Who cannot join
- > 60 minutes from the circulatory collapse to ROSC
- Time interval > 4 hours from cardiac arrest to initiation of therapeutic hypothermia
- Terminal illness
- Coagulation disorder
- Unwitnessed asystolia
- Cerebral performance category 3-4 before the cardiac arrest
Show all 13Show fewer
- Severe persistent cardiogenic shock
- Pregnancy
- Persistent cardiogenic shock (systolic blood pressure < 80 despite inotropic treatment)
- New apoplexy or intracerebral hemorrhage
- Lack of consent from the relatives
- Lack of consent from the GP
- Lack of consent from the patient if he/she wakes up and is relevant
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby
Aarhus, Aarhus N, 8200
About this study
Official title: The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest.
The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia
Our specific aims are:
- To investigate the whole blood coagulation using the rotational thromboelastometry.
- To investigate the function of platelets
- Conditions
- Hypothermia, Heart Arrest, Hemostasis, Coagulants
- Being tested
- Therapeutic hypothermia
- Keywords
- Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest
- Medical subject headings
- Hypothermia, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic hypothermiaOther
Therapeutic hypothermia with a target temperature between 32-34°C.
| Study group | Role | What they receive |
|---|---|---|
| 24 hours hypothermia | Active comparator | Therapeutic hypothermia for 24 hours after reaching target temperature Receives: Other: Therapeutic hypothermia |
| 48 hours hypothermia | Experimental | Therapeutic hypothermia for 48 hours after reaching target temperature Receives: Other: Therapeutic hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting time in seconds, EXTEM
Measured by thomboelastometry on the ROTEM®
Measured: After 46 hours
Area under the curve, COL-test
Platelet function will be measured using Multiplate®
Measured: After 46 hours
Secondary outcomes (10)
Clotting time in seconds, EXTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours and 70 hours
Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours, 46 hours and 70 hours
Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours, 46 hours and 70 hours
Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours, 46 hours and 70 hours
Area under the curve, COL-test
Platelet function will be measured using Multiplate®.
Measured: After 22 hours and 70 hours
Area under the curve,- ADP, ASPI and TRAP-test.
Platelet function will be measured using Multiplate®.
Measured: After 22 hours, 46 hours and 70 hours
Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours, 46 hours and 70 hours
Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
Measured by thomboelastometry on the ROTEM®.
Measured: After 22 hours, 46 hours and 70 hours
Area under the curve, Clot stability test
Measured: After 22 hours, 46 hours and 70 hours
Area under the curve, Thrombin generation
Measured: After 22 hours, 46 hours and 70 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anni Norgaard Jeppesen, MD, Principal investigator, Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258360
- Sponsor's protocol ID
- PROID7005
- Status last verified
- Mar 2016
- First submitted
- 29 Aug 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
Publications
Jeppesen AN, Duez C, Kirkegaard H, Grejs AM, Hvas AM. Fibrinolysis in Cardiac Arrest Patients Treated with Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):112-119. doi: 10.1089/ther.2022.0037. Epub 2022 Dec 6.
PubMed 36473198Jeppesen AN, Hvas AM, Duez CHV, Grejs AM, Ilkjaer S, Kirkegaard H. Prolonged targeted temperature management compromises thrombin generation: A randomised clinical trial. Resuscitation. 2017 Sep;118:126-132. doi: 10.1016/j.resuscitation.2017.06.004. Epub 2017 Jun 7.
PubMed 28602694
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.
- ClinicalTrials.gov ID
- NCT02258360
- Acronym / sponsor ID
- PROID7005
- Conditions
- Hypothermia, Heart Arrest, Hemostasis, Coagulants
- Keywords
- Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Oct 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.
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest.
The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia
Our specific aims are:
- To investigate the whole blood coagulation using the rotational thromboelastometry.
- To investigate the function of platelets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours hypothermia | Active comparator | Other: Therapeutic hypothermiaTherapeutic hypothermia for 24 hours after reaching target temperature |
| 48 hours hypothermia | Experimental | Other: Therapeutic hypothermiaTherapeutic hypothermia for 48 hours after reaching target temperature |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Out of hospital cardiac arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Key exclusion criteria (13 listed)
- > 60 minutes from the circulatory collapse to ROSC
- Time interval > 4 hours from cardiac arrest to initiation of therapeutic hypothermia
- Terminal illness
- Coagulation disorder
- Unwitnessed asystolia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic hypothermiaTherapeutic hypothermia with a target temperature between 32-34°C. | Other | 24 hours hypothermia, 48 hours hypothermia |
Primary outcome
Clotting time in seconds, EXTEM
Time frame: After 46 hours
Measured by thomboelastometry on the ROTEM®
Area under the curve, COL-test
Time frame: After 46 hours
Platelet function will be measured using Multiplate®
10 secondary outcomes
Clotting time in seconds, EXTEM
Time frame: After 22 hours and 70 hours
Clotting time in seconds, -INTEM, FIBTEM and HEPTEM
Time frame: After 22 hours, 46 hours and 70 hours
Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM
Time frame: After 22 hours, 46 hours and 70 hours
Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM
Time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, COL-test
Time frame: After 22 hours and 70 hours
Area under the curve,- ADP, ASPI and TRAP-test.
Time frame: After 22 hours, 46 hours and 70 hours
Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM
Time frame: After 22 hours, 46 hours and 70 hours
Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM
Time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, Clot stability test
Time frame: After 22 hours, 46 hours and 70 hours
Area under the curve, Thrombin generation
Time frame: After 22 hours, 46 hours and 70 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Derived from this study: PubMed 36473198Jeppesen AN, Duez C, Kirkegaard H, Grejs AM, Hvas AM. Fibrinolysis in Cardiac Arrest Patients Treated with Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):112-119. doi: 10.1089/ther.2022.0037. Epub 2022 Dec 6.
- Derived from this study: PubMed 28602694Jeppesen AN, Hvas AM, Duez CHV, Grejs AM, Ilkjaer S, Kirkegaard H. Prolonged targeted temperature management compromises thrombin generation: A randomised clinical trial. Resuscitation. 2017 Sep;118:126-132. doi: 10.1016/j.resuscitation.2017.06.004. Epub 2017 Jun 7.
Related trials for Hypothermia
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
Not yet recruiting
Hypothermic Oxygenated Machine PErfusion During Ex-vivo SPLITting in Liver Pediatric Transplantation (HOPESPLIT)
Pediatric Liver Transplantation
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.
Anni Norgaard Jeppesen, MD principal investigator
Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic hypothermia in people with 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 29 Mar 2016. 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?
Results are not available in the source record.
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?
Clotting time in seconds, EXTEM (time frame: After 46 hours). The study lists 2 primary outcomes in all. 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 NCT02258360, which also lists 2 linked publications.
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 29 Mar 2016.