Gastrointestinal BleedingNCT03669068
Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: THE ENDOHEM REGISTRY
An observational study of Gastrointestinal Bleeding and Cardiovascular Complication, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding, Cardiovascular Complication, Anticoagulants; Circulating, Hemorrhagic Disorder
- What is being tested?
- Gastrointestinal endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,602 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 30 May 2020
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)
Who may be able to join
- Age >= 18 years.
- Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.
- Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.
- Signed informed consent.
Who cannot join
- Negative to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry
This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.
- Conditions
- Gastrointestinal Bleeding, Cardiovascular Complication, Anticoagulants; Circulating, Hemorrhagic Disorder, Gastrointestinal Endoscopy
- Being tested
- Gastrointestinal endoscopy
- Keywords
- Gastrointestinal endoscopy, Oral anticoagulants, Gastrointestinal bleeding, Cardiovascular event
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhagic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal endoscopyProcedure or surgery
Two separated groups will be included in the registry:
- Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure.
- Patients undergoing elective gastrointestinal endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Elective endoscopy | Patients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding. Receives: Procedure: Gastrointestinal endoscopy | |
| Gastrointestinal bleeding | Patients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately Receives: Procedure: Gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cardiovascular events
Nº of patients during the study period presenting with a cardiovascular event, defined as any of the following entities: pulmonary thromboembolism, venous thromboembolism, acute coronary syndrome, arterial peripheral embolism or cerebrovascular accident.
Measured: 3 months
Secondary outcomes (1)
Incidence of therapeutic endoscopy-related gastrointestinal bleeding
Nº of patients during the study period presenting with therapeutic endoscopy-related gastrointestinal bleeding
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- 1,602 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca, Hospital Universitario Central de Asturias, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital, Hospital del Mar, Hospital de Viladecans, Hospital Clinic of Barcelona, Hospital de Avilés, Hospital General de Villalba, Hospital General de Granollers, Hospital Sant Pau
- Responsible party
- Principal investigator, Enrique Rodríguez de Santiago, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669068
- Sponsor's protocol ID
- HRC-ENDOHEM-02
- Status last verified
- Jul 2020
- First submitted
- 8 Sep 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Endoscopy in Patients With Prothrombotic Conditions: A Prospective, Multicentre, and Observational Registry
- ClinicalTrials.gov ID
- NCT03669068
- Acronym / sponsor ID
- HRC-ENDOHEM-02
- Conditions
- Gastrointestinal Bleeding, Cardiovascular Complication, Anticoagulants; Circulating, Hemorrhagic Disorder, Gastrointestinal Endoscopy
- Keywords
- Gastrointestinal endoscopy, Oral anticoagulants, Gastrointestinal bleeding, Cardiovascular event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- University of Salamanca, Hospital Universitario Central de Asturias, Hospital Universitario 12 de Octubre, Puerta de Hierro University Hospital, Hospital del Mar, Hospital de Viladecans, Hospital Clinic of Barcelona, Hospital de Avilés, Hospital General de Villalba, Hospital General de Granollers, Hospital Sant Pau
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 13 Sep 2018 (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.
This observational study evaluates the safety of gastrointestinal endoscopy in patients on oral anticoagulants (Vitamin K antagonists, rivaroxaban, dabigatran, edoxaban, and apixaban). This registry aims to assess the incidence, characteristics and risk factors for cardiovascular and bleeding events associated with an endoscopic procedure. Besides, it aims to evaluate the differences between Vitamin K antagonists and DOACs users and to estimate the impact of anticoagulation withdrawal time on the primary and secondary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective endoscopy | – | Procedure: Gastrointestinal endoscopyPatients undergoing gastrointestinal endoscopy unrelated to anticoagulant-induced gastrointestinal bleeding. |
| Gastrointestinal bleeding | – | Procedure: Gastrointestinal endoscopyPatients with anticoagulant-induced gastrointestinal bleeding will be analyzed separately |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran)
Key inclusion criteria (4 listed)
- Age >= 18 years.
- Patients with preoperative use of oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatrán) undergoing gastrointestinal endoscopy.
- Patients on oral anticoagulants (Vitamin K antagonist, apixaban, edoxaban, rivaroxaban or dabigatran) presenting with gastrointestinal bleeding, regardless of receiving gastrointestinal endoscopy.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Negative to participate in the study.
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 |
|---|---|---|
| Gastrointestinal endoscopyTwo separated groups will be included in the registry: 1. Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure. 2. Patients undergoing elective gastrointestinal endoscopy. | Procedure or surgery | Elective endoscopy, Gastrointestinal bleeding |
Primary outcome
Incidence of Cardiovascular events
Time frame: 3 months
Nº of patients during the study period presenting with a cardiovascular event, defined as any of the following entities: pulmonary thromboembolism, venous thromboembolism, acute coronary syndrome, arterial peripheral embolism or cerebrovascular accident.
1 secondary outcome
Incidence of therapeutic endoscopy-related gastrointestinal bleeding
Time frame: 3 months
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 31 Jul 2020.
- Individual participant dataSharing planned: Yes
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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 Gastrointestinal Bleeding and Cardiovascular Complication, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 4 inclusion and 1 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 31 Jul 2020. 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 Spain. 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 Cardiovascular events (time frame: 3 months). 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 31 Jul 2020.