Actively Recruiting

Age: 18Years +
All Genders
NCT07019077

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

Led by Centro Cardiologico Monzino · Updated on 2025-06-13

4719

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

C

Centro Cardiologico Monzino

Lead Sponsor

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �38 years
  • Scheduled for one of the following endoscopic procedures: EGDS with or without biopsy/polypectomy
  • Colonoscopy with or without biopsy/polypectomy
  • Echoguided endoscopy with or without biopsy/polypectomy
  • Double-balloon enteroscopy
  • ERCP (endoscopic retrograde cholangio-pancreatography) with or without sphincterotomy
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Known active tumors in the digestive tract
  • Emergency gastrointestinal procedures
  • Known bleeding disorders such as platelet count below 50,000/mmc
  • Current treatment with antiplatelet drugs like clopidogrel or other thienopyridines

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Centro Cardiologico Monzino; IRCCS

Milan, Italy

Actively Recruiting

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Research Team

B

Barbara Scimeca, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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