Late bleeding after invasive gastrointestinal endoscopy in people taking anticoagulants versus those not on anticoagulants
Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients
This study tries to see if adults on oral anticoagulants have more late bleeding after invasive gastrointestinal endoscopic procedures than adults who are not on anticoagulants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4719 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT07019077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) scheduled for one of the listed elective invasive gastrointestinal endoscopic procedures, whether they are taking oral anticoagulants (VKAs or DOACs) or not, are the intended participants.
Not a fit: People undergoing emergency gastrointestinal procedures, those with active gastroenteric malignancy, major intrinsic bleeding disorders, or taking clopidogrel/thienopyridines are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians choose safer anticoagulant management strategies around endoscopic procedures to reduce late bleeding risk.
How similar studies have performed: Existing observational studies and guideline statements address periprocedural anticoagulant management and bleeding risk, but direct comparative data specifically on late haemorrhage across VKAs, DOACs and non-anticoagulated patients remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- Centro Cardiologico Monzino; IRCCS — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Barbara Scimeca, MD
- Email: barbara.scimeca@cardiologicomonzino.it
- Phone: 02582579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.