BleedingEMOSCOPIONCT07019077
Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients
An observational study of Bleeding, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- How many people
- 4,719 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2025to 30 Jun 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino; IRCCS
Milan
Chiara Centenaro, 0258002031 ext. +39, chiara.centenaro@cardiologicomonzino.it
About this study
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
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the manoeuvre.
Secondary outcomes (1)
Incidence of early bleeding
Secondary objectives:
- Incidence of early bleeding (first 24 hours) in relation to pre-procedural withdrawal or no withdrawal
- Possible difference in bleeding incidence by anticoagulant class (AVK vs DOAC vs heparin)
- Possible difference in bleeding incidence by type of endoscopic manoeuvre (low or high risk of bleeding)
- Possible difference in bleeding incidence by mode of reintroduction of anticoagulant therapy
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start19 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,719 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Humanitas Research Hospital IRCCS, Rozzano-Milan, Valduce Hospital, Azienda Ospedaliera di Lecco, Istituto Auxologico Italiano, Università degli Studi dell'Insubria, ASST Sette Laghi
- Responsible party
- Principal investigator, Barbara Scimeca, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019077
- Sponsor's protocol ID
- L2-223
- Acronym
- EMOSCOPIO
- Status last verified
- May 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Late Haemorrhage After Invasive Gastroenterological Endoscopic Manoeuvre in Patients Treated With Anticoagulants Compared to Non-anticoagulated Patients
- ClinicalTrials.gov ID
- NCT07019077
- Acronym / sponsor ID
- EMOSCOPIO / L2-223
- Conditions
- Bleeding
- Keywords
- endoscopic gastroenterological manoeuvre
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,719 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Humanitas Research Hospital IRCCS, Rozzano-Milan, Valduce Hospital, Azienda Ospedaliera di Lecco, Istituto Auxologico Italiano, Università degli Studi dell'Insubria, ASST Sette Laghi
- Study start
- 19 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (7 listed)
- Age >= 18 years
- Expected endoscopic manoeuvre among those listed below
- EGDS ± biopsy/polypectomy
- Colonoscopy ± biopsy/polypectomy
- Echoguided endoscopy ± biopsy/polypectomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of late bleeding
Time frame: 30 days after the manoeuvre.
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.
1 secondary outcome
Incidence of early bleeding
Time frame: First 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Scimeca, MD (02582579 ext. +39, barbara.scimeca@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of late bleeding (time frame: 30 days after the manoeuvre.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.