Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures
NCT ID: NCT02734316
Last Updated: 2018-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
531 participants
OBSERVATIONAL
2016-03-31
2017-06-30
Brief Summary
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Detailed Description
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All consecutive patients undergoing elective procedures and providing informed consent will be included.
Primary end-point:
incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines
Secondary end points:
* incidence of major bleeding and clinically relent non-major events in the overall patient population
* incidence of bleeding events in the overall patient population
* incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines
* compliance with ESGE guidelines
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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endoscopic procedure
Evaluation of adverse events in patients on DOACs undergoing GI endoscopy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* not willing patient
ALL
Yes
Sponsors
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Valduce Hospital
OTHER
Responsible Party
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Franco Radaelli
MD
Locations
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Valduce Hospital
Como, , Italy
Countries
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References
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Radaelli F, Fuccio L, Paggi S, Hassan C, Repici A, Rondonotti E, Semeraro R, Di Leo M, Anderloni A, Amato A, Trovato C, Bravi I, Buda A, de Bellis M, D'Angelo V, Segato S, Tarantino O, Musso A, Fasoli R, Frazzoni L, Liverani E, Fabbri C, Di Giulio E, Esposito G, Pigo F, Iannone A, Dentali F; Bowell Group. Periendoscopic management of direct oral anticoagulants: a prospective cohort study. Gut. 2019 Jun;68(6):969-976. doi: 10.1136/gutjnl-2018-316385. Epub 2018 Jul 31.
Other Identifiers
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Version 3 10/2/216
Identifier Type: -
Identifier Source: org_study_id
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