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

NCT ID: NCT07019077

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4719 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

IRCCS Humanitas Milan Italy

UNKNOWN

Sponsor Role: collaborator

Valduce Hospital

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera di Lecco

OTHER

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: collaborator

Università degli Studi dell'Insubria

OTHER

Sponsor Role: collaborator

ASST Sette Laghi

OTHER

Sponsor Role: collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Barbara Scimeca

Principal Investigator - Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Cardiologico Monzino; IRCCS

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Barbara Scimeca, MD

Role: CONTACT

barbara.scimeca@cardiologicomonzino.it

02582579 ext. +39

Facility Contacts

Chiara Centenaro

Role: primary

chiara.centenaro@cardiologicomonzino.it

0258002031 ext. +39

Other Identifiers

L2-223

Identifier Type: -

Identifier Source: org_study_id