Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-27 @ 11:19 PM
Study NCT ID:
NCT02643992
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2015-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Per-procedural Concentration of Direct Oral Anticoagulants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2015-12-30', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DOAC concentration', 'timeFrame': 'beginning of invasive procedure'}]}, 'conditionsModule': {'conditions': ['Per-procedural Concentrations of Oral Anticoagulants']}, 'referencesModule': {'references': [{'pmid': '30991108', 'type': 'DERIVED', 'citation': 'Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration (\\[DOAC\\]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.\n\nObjectives: To investigate the factors associated with per-procedural \\[DOAC\\]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural \\[DOAC\\], defined as \\[DOAC\\] \\< 30 ng/mL.\n\nMethods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. \\[DOAC\\], will be measured during invasive procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient undergoing invasive procedure and treated with DOAC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient over 18 years-old\n* undergoing invasive procedure\n* treated with DOAC\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02643992', 'acronym': 'CORIDA', 'briefTitle': 'Per-procedural Concentration of Direct Oral Anticoagulants', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'orgStudyIdInfo': {'id': 'AGR_2014-13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DOAC concentration measurement', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild (FOR)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}