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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24 hours hypothermia | Active Comparator | Therapeutic hypothermia for 24 hours after reaching target temperature |
|
| 48 hours hypothermia | Experimental | Therapeutic hypothermia for 48 hours after reaching target temperature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic hypothermia | Other | Therapeutic hypothermia with a target temperature between 32-34°C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clotting time in seconds, EXTEM | Measured by thomboelastometry on the ROTEM® | After 46 hours |
| Area under the curve, COL-test | Platelet function will be measured using Multiplate® | After 46 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clotting time in seconds, EXTEM | Measured by thomboelastometry on the ROTEM®. | After 22 hours and 70 hours |
| Clotting time in seconds, -INTEM, FIBTEM and HEPTEM | Measured by thomboelastometry on the ROTEM®. |
| Measure | Description | Time Frame |
|---|---|---|
| International normalized ratio | After 22 hours, 46 hours and 70 hours | |
| APTT (activated partial thromboplastin time) in seconds | After 22 hours, 46 hours and 70 hours | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anni Norgaard Jeppesen, MD | Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby | Aarhus | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36473198 | Derived | 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. | |
| 28602694 | Derived | Jeppesen 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. |
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| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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| After 22 hours, 46 hours and 70 hours |
| Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM | Measured by thomboelastometry on the ROTEM®. | After 22 hours, 46 hours and 70 hours |
| Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM | Measured by thomboelastometry on the ROTEM®. | After 22 hours, 46 hours and 70 hours |
| Area under the curve, COL-test | Platelet function will be measured using Multiplate®. | After 22 hours and 70 hours |
| Area under the curve,- ADP, ASPI and TRAP-test. | Platelet function will be measured using Multiplate®. | After 22 hours, 46 hours and 70 hours |
| Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM | Measured by thomboelastometry on the ROTEM®. | After 22 hours, 46 hours and 70 hours |
| Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM | Measured by thomboelastometry on the ROTEM®. | After 22 hours, 46 hours and 70 hours |
| Area under the curve, Clot stability test | After 22 hours, 46 hours and 70 hours |
| Area under the curve, Thrombin generation | After 22 hours, 46 hours and 70 hours |
| Fibrinogen in mol/l |
| After 22 hours, 46 hours and 70 hours |
| Antithrombin in 10^3 int.units/l | After 22 hours, 46 hours and 70 hours |
| D-dimer in mg/l FEU | After 22 hours, 46 hours and 70 hours |
| Trombine time in seconds | After 22 hours, 46 hours and 70 hours |
| D002318 | Cardiovascular Diseases |