Anticoagulant DisordersNCT02734316
Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures
An observational study of Anticoagulant Disorders, run by Valduce Hospital at 1 site in Italy.
Trial summary
The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anticoagulant Disorders
- What is being tested?
- endoscopic procedure
- How many people
- 531 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to 30 Jun 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy
Who may be able to join
- patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy
Who cannot join
- inform consent not possible to obtain
- not willing patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study
The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.
Read the detailed description
This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with.
All consecutive patients undergoing elective procedures and providing informed consent will be included.
Primary end-point:
incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines
Secondary end points:
- incidence of major bleeding and clinically relent non-major events in the overall patient population
- incidence of bleeding events in the overall patient population
- incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines
- compliance with ESGE guidelines
- Conditions
- Anticoagulant Disorders
- Being tested
- endoscopic procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic procedureOther
Evaluation of adverse events in patients on DOACs undergoing GI endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hemorrhagic events after endoscopic procedures
incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant DisordersStudies 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
- Cross-sectional
- Enrolment
- 531 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734316
- Sponsor's protocol ID
- Version 3 10/2/216
- Status last verified
- Feb 2018
- First submitted
- 29 Mar 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Radaelli F, Fuccio L, Paggi S, Hassan C, Repici A, Rondonotti E, Semeraro R, Di Leo M, Anderloni A, Amato A, Trovato C, Bravi I, Buda A, de Bellis M, D'Angelo V, Segato S, Tarantino O, Musso A, Fasoli R, Frazzoni L, Liverani E, Fabbri C, Di Giulio E, Esposito G, Pigo F, Iannone A, Dentali F; Bowell Group. Periendoscopic management of direct oral anticoagulants: a prospective cohort study. Gut. 2019 Jun;68(6):969-976. doi: 10.1136/gutjnl-2018-316385. Epub 2018 Jul 31.
PubMed 30064986
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Direct Oral Anti-Coagulants (DOACs) for Gastrointestinal Endoscopy Procedures: an Observational, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02734316
- Acronym / sponsor ID
- Version 3 10/2/216
- Conditions
- Anticoagulant Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
The use of Direct Oral Anti-Coagulants (DOACs) is expanding, but their proper management in patients undergoing endoscopic procedures is still not completely clear. Current European guidelines are based on weak data. This observational study aims to evaluate the peri-endoscopic management of DOACs in clinical practice and the incidence of adverse events.
Detailed description
This observational study is aimed at evaluating the peri-endoscopic management of DOACs in patients undergoing elective gastrointestinal endoscopy procedures and the adverse events (bleeding and thromboembolic events) associated with.
All consecutive patients undergoing elective procedures and providing informed consent will be included.
Primary end-point:
incidence of major bleeding events according to International Society Thrombosis Haemostasis (ISTH) criteria and clinically relevant non-major bleeding events occuring during the endoscopy procedures or within 30 days, according to International Society Thrombosis Haemostasis (ISTH) criteria in patients in which DOACs have been managed according to European Society of Gastrointestinal Endoscopy (ESGE) guidelines
Secondary end points:
- incidence of major bleeding and clinically relent non-major events in the overall patient population
- incidence of bleeding events in the overall patient population
- incidence of thromboembolic events in the overall patient population and in patients in which DOACs have been managed according to ESGE guidelines
- compliance with ESGE guidelines
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy
Key inclusion criteria (1 listed)
- patients (both inpatients and outpatients) undergoing endoscopic procedures during DOACs therapy
Key exclusion criteria (2 listed)
- inform consent not possible to obtain
- not willing patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic procedureEvaluation of adverse events in patients on DOACs undergoing GI endoscopy | Other | – |
Primary outcome
incidence of hemorrhagic events after endoscopic procedures
Time frame: 12 months
incidence of hemorrhagic events after endoscopic procedures when the European Guidelines (ESGE) are followed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 30064986Radaelli F, Fuccio L, Paggi S, Hassan C, Repici A, Rondonotti E, Semeraro R, Di Leo M, Anderloni A, Amato A, Trovato C, Bravi I, Buda A, de Bellis M, D'Angelo V, Segato S, Tarantino O, Musso A, Fasoli R, Frazzoni L, Liverani E, Fabbri C, Di Giulio E, Esposito G, Pigo F, Iannone A, Dentali F; Bowell Group. Periendoscopic management of direct oral anticoagulants: a prospective cohort study. Gut. 2019 Jun;68(6):969-976. doi: 10.1136/gutjnl-2018-316385. Epub 2018 Jul 31.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Anticoagulant Disorders, run by Valduce Hospital 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hemorrhagic events after endoscopic procedures (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734316, which also lists 1 linked publication.
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 8 Feb 2018.