Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02258360
Status:
UNKNOWN
Last Update Posted:
2016-03-29
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypothermia and Hemostasis After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2014-08-29', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'International normalized ratio', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'APTT (activated partial thromboplastin time) in seconds', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'Fibrinogen in mol/l', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'Antithrombin in 10^3 int.units/l', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'D-dimer in mg/l FEU', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'Trombine time in seconds', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}], 'primaryOutcomes': [{'measure': 'Clotting time in seconds, EXTEM', 'timeFrame': 'After 46 hours', 'description': 'Measured by thomboelastometry on the ROTEM®'}, {'measure': 'Area under the curve, COL-test', 'timeFrame': 'After 46 hours', 'description': 'Platelet function will be measured using Multiplate®'}], 'secondaryOutcomes': [{'measure': 'Clotting time in seconds, EXTEM', 'timeFrame': 'After 22 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Clotting time in seconds, -INTEM, FIBTEM and HEPTEM', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Area under the curve, COL-test', 'timeFrame': 'After 22 hours and 70 hours', 'description': 'Platelet function will be measured using Multiplate®.'}, {'measure': 'Area under the curve,- ADP, ASPI and TRAP-test.', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Platelet function will be measured using Multiplate®.'}, {'measure': 'Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM', 'timeFrame': 'After 22 hours, 46 hours and 70 hours', 'description': 'Measured by thomboelastometry on the ROTEM®.'}, {'measure': 'Area under the curve, Clot stability test', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}, {'measure': 'Area under the curve, Thrombin generation', 'timeFrame': 'After 22 hours, 46 hours and 70 hours'}]}, 'conditionsModule': {'keywords': ['Thromboelastometry', 'Haemostasis', 'Hypothermia', 'Heart Arrest'], 'conditions': ['Hypothermia', 'Heart Arrest', 'Hemostasis', 'Coagulants']}, 'referencesModule': {'references': [{'pmid': '36473198', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28602694', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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\n\nOur specific aims are:\n\n* To investigate the whole blood coagulation using the rotational thromboelastometry.\n* To investigate the function of platelets'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out of hospital cardiac arrest of presumed cardiac cause\n* Return of spontaneous circulation (ROSC)\n* Glasgow Coma Score \\< 8\n* Age \\> 18 years and \\< 80 years\n\nExclusion Criteria:\n\n* \\> 60 minutes from the circulatory collapse to ROSC\n* Time interval \\> 4 hours from cardiac arrest to initiation of therapeutic hypothermia\n* Terminal illness\n* Coagulation disorder\n* Unwitnessed asystolia\n* Cerebral performance category 3-4 before the cardiac arrest\n* Severe persistent cardiogenic shock\n* Pregnancy\n* Persistent cardiogenic shock (systolic blood pressure \\< 80 despite inotropic treatment)\n* New apoplexy or intracerebral hemorrhage\n* Lack of consent from the relatives\n* Lack of consent from the GP\n* Lack of consent from the patient if he/she wakes up and is relevant'}, 'identificationModule': {'nctId': 'NCT02258360', 'briefTitle': 'Hypothermia and Hemostasis After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Effect of Therapeutic Hypothermia After Cardiac Arrest on the Haemostasis.', 'orgStudyIdInfo': {'id': 'PROID7005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '24 hours hypothermia', 'description': 'Therapeutic hypothermia for 24 hours after reaching target temperature', 'interventionNames': ['Other: Therapeutic hypothermia']}, {'type': 'EXPERIMENTAL', 'label': '48 hours hypothermia', 'description': 'Therapeutic hypothermia for 48 hours after reaching target temperature', 'interventionNames': ['Other: Therapeutic hypothermia']}], 'interventions': [{'name': 'Therapeutic hypothermia', 'type': 'OTHER', 'description': 'Therapeutic hypothermia with a target temperature between 32-34°C.', 'armGroupLabels': ['24 hours hypothermia', '48 hours hypothermia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital, Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Anni Norgaard Jeppesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}