Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-03 @ 6:47 AM
Study NCT ID:
NCT02825394
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific PoC Testing of Coagulation in Patients Treated With DOAC 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood samples, citrated blood samples and citrated plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of direct oral anticoagulant (DOAC) plasma concentration with Cascade Abrazo point-of-care testing (POCT) result', 'timeFrame': '24 hours', 'description': 'DOAC concentrations determined by ultra-performance liquid chromatography-tandem mass spectrometry'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy (sensitivity and specificity) of the Cascade Abrazo POCT to rule out or detect relevant DOAC plasma levels', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based prothrombin time (PT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based activated thromboplastin time (aPTT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based thrombin time (TT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based diluted thrombin time (dTT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based ecarin clotting time (ECT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of DOAC plasma concentrations with laboratory-based anti-Xa activity assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of edoxaban plasma concentrations with CoaguChek point-of-care prothrombin time (PT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care prothrombin time (PT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated thromboplastin time (aPTT) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time plus (ACT+) assay', 'timeFrame': '24 hours'}, {'measure': 'Correlation of edoxaban plasma concentrations with Hemochron Signature point-of-care activated clotting time low-range (ACT-LR) assay', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anticoagulation With NOAC']}, 'referencesModule': {'references': [{'pmid': '33641678', 'type': 'DERIVED', 'citation': 'Hartig F, Birschmann I, Peter A, Horber S, Ebner M, Sonnleitner M, Spencer C, Bombach P, Stefanou MI, Tunnerhoff J, Mengel A, Kuhn J, Ziemann U, Poli S. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract. 2021 Mar 1;3(1):9. doi: 10.1186/s42466-021-00105-4.'}, {'pmid': '33469905', 'type': 'DERIVED', 'citation': 'Hartig F, Birschmann I, Peter A, Ebner M, Spencer C, Gramlich M, Richter H, Kuhn J, Lehmann R, Blumenstock G, Zuern CS, Ziemann U, Poli S. Specific Point-of-Care Testing of Coagulation in Patients Treated with Dabigatran. Thromb Haemost. 2021 Jun;121(6):782-791. doi: 10.1055/s-0040-1721775. Epub 2021 Jan 14.'}]}, 'descriptionModule': {'briefSummary': 'The investigators study aims to test the correlation between the Cascade Abrazo point-of-care testing (POCT) device (Helena Laboratories, USA) and plasma levels of apixaban, dabigatran, edoxaban and rivaroxaban, and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of direct oral anticoagulants (DOAC) in real-life patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Part A: patients, who are newly started on oral anticoagulation with apixaban, dabigatran, edoxaban or rivaroxaban for secondary prevention of thromboembolic events.\n\nPart B: patients, on-treatment with apixaban, dabigatran, edoxaban or rivaroxaban.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part A only: planned initiation of treatment with apixaban, dabigatran, edoxaban or rivaroxaban\n* Part B only: ongoing treatment with apixaban, dabigatran, edoxaban or rivaroxaban\n* Age ≥ 18 years\n* Written informed consent by patient\n\nExclusion Criteria:\n\n* Part A only: intake of vitamin K antagonists or direct oral anticoagulants (DOAC) ≤ 14 days prior to study participation\n* Part B only: intake of vitamin K antagonists or different DOAC ≤ 14 days prior to study participation\n* Intake of unfractionated heparin ≤ 12 hours, low-molecular-weight heparin ≤ 24h, heparinoids (e.g. fondaparinux) ≤ 72h, or direct thrombin inhibitors other than dabigatran ≤ 72h prior to study participation\n* Part A only: abnormal routine coagulation test values at baseline (defined by INR \\> 1.2, Quick \\< 70% or aPTT \\> 40 sec)\n* History of coagulopathy'}, 'identificationModule': {'nctId': 'NCT02825394', 'acronym': 'SPOCT-DOAC 1', 'briefTitle': 'Specific PoC Testing of Coagulation in Patients Treated With DOAC 1', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Specific Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants Part 1', 'orgStudyIdInfo': {'id': '270/2015BO1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'apixaban initiation', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}, {'label': 'apixaban on-treatment', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}, {'label': 'dabigatran initiation', 'description': 'N=20', 'interventionNames': ['Other: ecarin clotting time point-of-care testing (ECT-POCT)']}, {'label': 'dabigatran on-treatment', 'description': 'N=20', 'interventionNames': ['Other: ecarin clotting time point-of-care testing (ECT-POCT)']}, {'label': 'rivaroxaban initiation', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}, {'label': 'rivaroxaban on-treatment', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}, {'label': 'edoxaban initiation', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}, {'label': 'edoxaban on-treatment', 'description': 'N=20', 'interventionNames': ['Other: anti-Xa activity point-of-care testing (aXa-POCT)']}], 'interventions': [{'name': 'anti-Xa activity point-of-care testing (aXa-POCT)', 'type': 'OTHER', 'otherNames': ['Cascade Abrazo with ENOX and ENOX LR test cards'], 'armGroupLabels': ['apixaban initiation', 'apixaban on-treatment', 'edoxaban initiation', 'edoxaban on-treatment', 'rivaroxaban initiation', 'rivaroxaban on-treatment']}, {'name': 'ecarin clotting time point-of-care testing (ECT-POCT)', 'type': 'OTHER', 'otherNames': ['Cascade Abrazo with DTM test cards'], 'armGroupLabels': ['dabigatran initiation', 'dabigatran on-treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sven Poli, MD MSc', 'role': 'CONTACT', 'email': 'sven.poli@uni-tuebingen.de', 'phone': '+497071290', 'phoneExt': '68300'}, {'name': 'Florian Härtig, MD', 'role': 'CONTACT', 'email': 'florian.haertig@uni-tuebingen.de', 'phone': '+497071290', 'phoneExt': '80417'}], 'facility': 'University Hospital Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Sven Poli, MD MSc', 'role': 'CONTACT', 'email': 'sven.poli@uni-tuebingen.de', 'phone': '+497071290', 'phoneExt': '68300'}, {'name': 'Florian Härtig, MD', 'role': 'CONTACT', 'email': 'florian.haertig@uni-tuebingen.de', 'phone': '+497071290', 'phoneExt': '80417'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Diabetes Center North Rhine-Westphalia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MSc', 'investigatorFullName': 'Dr. Sven Poli', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}