Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients

NCT07019077 | Recruiting

• 1 other identifier: L2-223
• Study Type: observational
• Target: 4,719
• Locations: 1 country
• Sites: 1

Brief Summary

Patients on oral anticoagulant therapy with vitamin K antagonists (AVKs; warfarin and acenocoumarol) and direct oral anticoagulants (DOACs; apixaban, dabigatran, edoxaban and rivaroxaban), are advised to consider discontinuing treatment in anticipation of invasive manoeuvres. Guidelines and expert consensus recommend, in clinical conditions with a high risk of bleeding, to suspend oral anticoagulant treatment with DOACs 2 or 3 days before the procedure, depending on the glomerular filtrate, to suspend warfarin from day -5 and acenocoumarol from day -4, and to introduce heparins from day -3 after discontinuation of AVKs (so-called 'bridging therapy') for manoeuvres with a high risk of bleeding. In manoeuvres with a low bleeding risk it is possible not to suspend the anticoagulant or to reduce its intensity. Obviously, the patient's intrinsic haemorrhagic and thrombotic risk (antiplatelet intake, renal insufficiency, hepatopathy, age, mechanical valve prosthesis, oncological condition, etc.) must also be taken into account in the overall assessment of pre-procedural preparation. Gastroenterological endoscopic manoeuvres are generally considered to be at low haemorrhagic risk even if biopsy is planned, but are at high haemorrhagic risk if polypectomy or mucosectomy is planned. The most complex problem arises at the time of re-introduction of anticoagulant post-procedure. In fact, studies evaluating this specific aspect are very few and heterogeneous and mostly retrospective. The variables that are associated with an increased risk of bleeding are: the number and site of polypectomies, the diameter of the polyps, and local haemostasis techniques. Late haemorrhages (\>24 hours) are of concern because the patient is generally at home and because, by the time the eschar falls out (varying between 4 and 10 days post-procedure), they have already resumed anticoagulation. However, there are no prospective studies of sufficient number to clarify whether the reintroduction of anticoagulation modifies the haemorrhagic risk, when is the time of greatest risk after the procedure, and which variables associated with the patient and the procedure most modify the haemorrhagic risk.

Conditions

Bleeding

Keywords

endoscopic gastroenterological manoeuvre

Outcome Measures

Primary Outcomes (1)

• Incidence of late bleeding

  The primary objective is to assess the incidence of late (\>24 hours) bleeding from the gastro-enteric tract in anticoagulated patients after low and high risk endoscopic manoeuvres and to compare it with that observed in non-anticoagulated patients in the first 30 days after the manoeuvre.

  30 days after the manoeuvre.

Secondary Outcomes (1)

• Incidence of early bleeding

  First 24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with/without anticoagulant treatment who are candidates for gastroenterological endoscopic procedures, either at low haemorrhagic risk (\<1%) or at high haemorrhagic risk (\>=1%).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• Valduce Hospital: collaborator
• Azienda Ospedaliera di Lecco: collaborator
• Istituto Auxologico Italiano: collaborator
• Università degli Studi dell'Insubria: collaborator
• ASST Sette Laghi: collaborator

Study Sites (1)

Centro Cardiologico Monzino; IRCCS

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Barbara Scimeca, MD

CONTACT

02582579; barbara.scimeca@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Medical Doctor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

IT (1)