Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-02-19 @ 11:13 AM
Study NCT ID:
NCT03754868
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2018-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-22', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-22', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor V [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor X [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.'}, {'measure': 'Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.'}], 'secondaryOutcomes': [{'measure': 'vWF-Antigen', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Measurement of the vWF-Antigen'}, {'measure': 'Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy', 'timeFrame': 'Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation', 'description': 'Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity \\[%\\]'}, {'measure': 'Changes in CT-EXTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.'}, {'measure': 'Changes in CT-INTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.'}, {'measure': 'Changes in CT-FIBTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clotting time (CT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.'}, {'measure': 'Changes in CT-HEPTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clotting time (CT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.'}, {'measure': 'Changes in CFT-EXTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.'}, {'measure': 'Changes in CFT-INTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.'}, {'measure': 'Changes in CFT-FIBTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clot formation time (CFT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.'}, {'measure': 'Changes in CFT-HEPTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in clot formation time (CFT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.'}, {'measure': 'Changes in MCF-EXTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.'}, {'measure': 'Changes in MCF-INTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.'}, {'measure': 'Changes in MCF-FIBTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in maximum clot firmness (MCF) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in millimeters.'}, {'measure': 'Changes in MCF-HEPTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in maximum clot firmness (MCF) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in millimeters.'}, {'measure': 'Changes in Alpha angle-EXTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.'}, {'measure': 'Changes in Alpha angle-INTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.'}, {'measure': 'Changes in Alpha angle-FIBTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in Alpha angle in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in degree.'}, {'measure': 'Changes in Alpha angle-HEPTEM', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Changes in Alpha angle in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in degree.'}, {'measure': 'Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).'}, {'measure': 'Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).'}, {'measure': 'Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation', 'description': 'Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).'}, {'measure': 'Light transmission aggregometry', 'timeFrame': '6 hours and 7 days after canulation', 'description': 'Measurement of platelet function'}, {'measure': 'Quick', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of Quick in %'}, {'measure': 'activated partial thromboplastin time (aPTT)', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of aPTT in seconds'}, {'measure': 'Fibrinogen', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of fibrinogen concentration in mg/dl'}, {'measure': 'Platelet count', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of platelet count/µl'}, {'measure': 'activated clotting time (ACT)', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of ACT in seconds'}, {'measure': 'Antithrombin III (ATIII)', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'Measurement of ATIII in %'}, {'measure': 'Measurement of Anti-Xa-Activity in %', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation', 'description': 'Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect'}, {'measure': 'D-Dimers', 'timeFrame': 'Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation', 'description': 'Measurement of D-Dimers'}, {'measure': 'hemoglobin', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'hemoglobin concentration in g/dl'}, {'measure': 'leucocyte count', 'timeFrame': 'Pre-canulation, 6 hours and daily from day 1- day 21after canulation', 'description': 'leucocyte count/µl'}, {'measure': 'Hemorrhagic complications', 'timeFrame': 'Daily from day 1-21', 'description': 'Structured documentation of hemorrhagic complications'}, {'measure': 'Thrombotic complications', 'timeFrame': 'Daily from day 1-21', 'description': 'Structured documentation of thrombotic complications'}, {'measure': 'Oxygenator State', 'timeFrame': 'Daily from day 1-21', 'description': 'Structured documentation of the state of the oxygenator including search for thrombotic material'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'Coagulation monitoring', 'point-of-care'], 'conditions': ['Extracorporeal Membrane Oxygenation Complication', 'Coagulation Factor Deficiency']}, 'descriptionModule': {'briefSummary': 'Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for a Veno-venous extracorporeal membrane oxygenation therapy\n\nExclusion Criteria:\n\n* Known coagulation disorders\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT03754868', 'briefTitle': 'Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Goettingen'}, 'officialTitle': 'Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy', 'orgStudyIdInfo': {'id': '19/5/13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Detailed coagulation monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'overallOfficials': [{'name': 'Onnen Moerer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, University Medical Center Goettingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Goettingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident for Anesthesiology, Principal Investigator', 'investigatorFullName': 'Saskia Wand', 'investigatorAffiliation': 'University Hospital Goettingen'}}}}