Clinical trial NCT02734316: Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures
Official title: Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulant Disorders
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 531
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy

Brief summary: The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.

Detailed description: This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with.

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

Eligibility criteria: Inclusion Criteria:

* patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy

Exclusion Criteria:

* inform consent not possible to obtain
* not willing patient

Primary outcomes:
measure: incidence of hemorrhagic events after endoscopic procedures
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital
Study officials:
References:
citation: 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.