Late bleeding after invasive gastrointestinal endoscopy in people taking anticoagulants versus those not on anticoagulants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will compare the incidence of late haemorrhage after a range of invasive gastroenterological endoscopic procedures in adults on oral anticoagulants (vitamin K antagonists and direct oral anticoagulants) versus non-anticoagulated adults. Enrolled patients will undergo procedures such as EGDS, colonoscopy, echo-guided endoscopy, double-balloon enteroscopy, or ERCP, and investigators will record periprocedural anticoagulant management including interruption and any bridging with heparin. Patients with emergency procedures, active gastrointestinal cancer, severe intrinsic bleeding diatheses, or on thienopyridine antiplatelets are excluded. Outcomes will relate late post-procedure bleeding events to anticoagulant type and periprocedural strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18 years
* Expected endoscopic manoeuvre among those listed below
* EGDS ± biopsy/polypectomy
* Colonoscopy ± biopsy/polypectomy
* Echoguided endoscopy ± biopsy/polypectomy
* Double-balloon enteroscopy
* ERCP (endoscopic retrograde cholangio-pancreatography) ± sphincterotomy

Exclusion Criteria:

* Age \< 18 years
* Known active neoplasms of the gastroenteric tract
* Gastrointestinal procedures performed as an emergency
* Patients with an intrinsic haemorrhagic diathesis (e.g. known plateletopenia \< 50,000/mmc)
* Patients on antiplatelet treatment with clopidogrel or other thienopyridines

Where it's running

• Centro Cardiologico Monzino; IRCCS
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Barbara Scimeca, MD
• Email: barbara.scimeca@cardiologicomonzino.it
• Phone: 02582579

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.