NCT02734316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
531

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

March 29, 2016

Last Update Submit

February 6, 2018

Conditions

Anticoagulant Disorders

Outcome Measures

Primary Outcomes (1)

  • incidence of hemorrhagic events after endoscopic procedures

    incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed

    12 months

Interventions

endoscopic procedureOTHER

Evaluation of adverse events in patients on DOACs undergoing GI endoscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • inform consent not possible to obtain
  • not willing patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 30064986DERIVED

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 12, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 30, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

IT(1)