Obscure Gastrointestinal BleedingBEACON-IDANCT07089030
Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy
A study testing Standard endoscopic evaluation and Conservative Medical Management in people with Obscure Gastrointestinal Bleeding and Iron-Deficiency Anemia, run by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec at 1 site in Canada.
Trial summary
This is a single-center, randomized pilot study evaluating the feasibility and safety of two management strategies for patients on antithrombotic therapy who present with obscure gastrointestinal bleeding (OGIB). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obscure Gastrointestinal Bleeding, Iron-Deficiency Anemia, Antithrombotic Therapy
- What is being tested?
- Standard endoscopic evaluation and Conservative Medical Management
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jun 2023to 6 Jun 2026
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and postmenopausal women with iron deficiency anemia, and premenopausal women with iron deficiency anemia and a negative gynecological evaluation;
- Laboratory-confirmed iron deficiency anemia (hemoglobin < 120 g/L for women, < 130 g/L for men, and ferritin < 30 ng/L);
- Patients receiving anticoagulant or antiplatelet therapy
- Negative esophagogastroduodenoscopy (EGD), colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to study enrollment
- Willing and able to provide written informed consent
- Able to read and understand French
Who cannot join
- Ongoing overt gastrointestinal bleeding
- Acute coronary syndrome, acute neurological event, sepsis, or respiratory failure within the past week
- Pregnant women
- Known gastrointestinal or hematological malignancy
- Contraindications to capsule endoscopy
- History of bariatric surgery, gastrectomy, or segmental resection of the small intestine
- Inability to take oral iron
- Other sources of blood loss (e.g., urinary, gynecological, hematoma, hemolysis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier affilié universitaire régional de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9
Éva Mathieu, PhD, 819-697-3333 ext. 60756, eva.mathieu@ssss.gouv.qc.ca
Camille Abi-Raad, MD
About this study
Official title: A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
This is a single-center, randomized pilot study evaluating the feasibility and safety of two management strategies for patients on antithrombotic therapy who present with obscure gastrointestinal bleeding (OGIB). Participants will be randomized to either repeated endoscopic evaluations or a conservative medical approach with limited testing. The study aims to assess whether conservative management yields similar clinical outcomes and quality of life compared to standard repeated endoscopic procedures. Results will inform the design of a larger trial and address the current lack of guidelines for managing recurrent iron-deficiency anemia in this patient population.
Read the detailed description
Antithrombotic therapy plays a critical role in preventing thrombotic events in patients with atherosclerotic coronary artery disease and atrial fibrillation. However, these therapies are associated with an increased risk of gastrointestinal bleeding, including obscure gastrointestinal bleeding (OGIB), which is often recurrent and linked to high morbidity and mortality.
This single-center, prospective, randomized pilot study aims to assess the feasibility and safety of two different management strategies for patients on antithrombotic therapy presenting with OGIB. Approximately 20 participants will be randomized in a 1:1 ratio into two groups:
Group A will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or intravenous) or blood transfusions as needed.
Group B will receive a single round of gastrointestinal evaluation, iron supplementation or transfusions as needed, and regular laboratory monitoring (hemoglobin and ferritin levels).
The primary objective is to evaluate the feasibility of conducting a larger randomized controlled trial comparing conservative medical management to standard repeated endoscopic evaluation. The secondary objective is to compare the quality of life between the two groups.
This study will also assess recruitment strategies, measurement tools, and the safety of a "watchful waiting" approach. Ultimately, the findings will help determine whether endoscopic evaluation provides clinical benefit in patients with iron-deficiency anemia on antithrombotic therapy who have had negative initial endoscopic workups. Currently, there are no established guidelines for managing recurrent iron-deficiency anemia in this population.
- Being tested
- Standard endoscopic evaluation, Conservative Medical Management
- Keywords
- Obscure Gastrointestinal Bleeding, Iron-Deficiency Anemia, Antithrombotic Therapy, Anticoagulants, Antiplatelet Agents, Endoscopy, Gastrointestinal Hemorrhage
- Medical subject headings
- Anemia, Iron-Deficiency, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard endoscopic evaluationProcedure or surgery
Examinations of the gastrointestinal (GI) tract (including the stomach, small intestine, and colon) will be performed to identify the source of bleeding. These examinations may be repeated based on the treating physician's assessment. Iron supplementation (ferrous sulfate) will be administered either orally (per os) or intravenously (IV), and blood transfusions will be provided if necessary.
Conservative Medical ManagementProcedure or surgery
The investigational intervention involves a conservative treatment approach guided by a decision-making algorithm based on iron deficiency anemia values. This algorithm, developed from guidelines by the British Society of Gastroenterology and the American Gastroenterological Association, determines whether patients receive oral or IV ferrous sulfate or a blood transfusion. Laboratory parameters (hemoglobin, ferritin) will be monitored at weeks 4, 12, 38, and 64. After iron therapy, hemoglobin response will be assessed at 4 weeks, and treatment will continue for ~3 months post-normalization to ensure iron store repletion. Blood tests will be repeated every 6 months to detect recurrence.
| Study group | Role | What they receive |
|---|---|---|
| Standard Endoscopic Evaluation | Active comparator | Participants will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or IV) or blood transfusions as needed. Receives: Procedure: Standard endoscopic evaluation |
| Conservative Medical Management | Experimental | Participants will receive a single round of gastrointestinal evaluation, iron supplementation (oral or IV) or blood transfusions as needed, and regular lab monitoring (hemoglobin and ferritin levels). Receives: Procedure: Conservative Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Participant Enrollment
This will be evaluated by the :
- Proportion of eligible participants who consent and receive the allocated intervention; - Proportion of treated participants who complete both laboratory tests and the quality-of-life questionnaire twice during the study period.
Measured: 64 weeks
Hemoglobin level
Relative change of hemoglobin
Measured: At weeks 4, 12, 38, and 64 following enrollment
Hematocrit level
Relative change of hematocrit
Measured: At weeks 4, 12, 38, and 64 following enrollment
Ferritin
Relative change of ferritin
Measured: At weeks 4, 12, 38, and 64 following enrollment
Reticulocyte count
Relative change of Reticulocyte count
Measured: At weeks 4, 12, 38, and 64 following enrollment
Serum iron
Relative change of serum level
Measured: At weeks 4, 12, 38, and 64 following enrollment
Transferrin saturation
Relative change of transferrin saturation
Measured: At weeks 4, 12, 38, and 64 following enrollment
Total number of blood transfusions
The cumulative count of all blood transfusion events administered to a participant during the study period.
Measured: At weeks 4, 12, 38, and 64 following enrollment
Total number of dose of ferrous sulfate administered
The cumulative count of individual doses of ferrous sulfate given to a participant during the study period
Measured: At weeks 4, 12, 38, and 64 following enrollment
Adverse Events Reporting
Adverse events will be documented in the case report form (CRF). Events will be classified as serious or non-serious. A serious adverse event is defined as any event resulting in hospitalization, including death from any cause, cardiovascular events related to anemia, or the occurrence of active bleeding. The need to discontinue antithrombotic therapy due to persistent anemia will also be recorded.
Measured: Continuously monitored and recorded throughout the 12-month follow-up period
Secondary outcomes (2)
Endoscopic Investigations and Diagnoses in the Standard Care Group
For participants in the standard care group, all endoscopic procedures performed (e.g., upper endoscopy, colonoscopy, capsule endoscopy) and any resulting diagnoses will be recorded. This information will be used to characterize the diagnostic yield and clinical management in the standard intervention arm.
Measured: Throughout the 12-month follow-up period
Quality of Life Assessment (GIQLI)
Quality of life will be assessed using the Gastrointestinal Quality of Life Index (GIQLI), a validated 36-item questionnaire developed in Germany. It includes five subscales: gastrointestinal symptoms, emotional well-being, physical function, social function, and medical treatment. Each item is scored from 0 to 4, with a total score ranging from 0 to 144. Higher scores indicate better quality of life. The validated French version of the GIQLI (Slim et al., 1999) will be used in this study. Completion time is approximately 20 minutes.
Measured: At baseline and at week 64 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start6 Jun 2023
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obscure 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Claude Lehoux, Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- Investigators
- Éva Mathieu, PhD, Study director, Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089030
- Sponsor's protocol ID
- 2023-708
- Acronym
- BEACON-IDA
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
- ClinicalTrials.gov ID
- NCT07089030
- Acronym / sponsor ID
- BEACON-IDA / 2023-708
- Keywords
- Obscure Gastrointestinal Bleeding, Iron-Deficiency Anemia, Antithrombotic Therapy, Anticoagulants, Antiplatelet Agents, Endoscopy, Gastrointestinal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-QuébecUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 28 Jul 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.
This is a single-center, randomized pilot study evaluating the feasibility and safety of two management strategies for patients on antithrombotic therapy who present with obscure gastrointestinal bleeding (OGIB). Participants will be randomized to either repeated endoscopic evaluations or a conservative medical approach with limited testing. The study aims to assess whether conservative management yields similar clinical outcomes and quality of life compared to standard repeated endoscopic procedures. Results will inform the design of a larger trial and address the current lack of guidelines for managing recurrent iron-deficiency anemia in this patient population.
Detailed description
Antithrombotic therapy plays a critical role in preventing thrombotic events in patients with atherosclerotic coronary artery disease and atrial fibrillation. However, these therapies are associated with an increased risk of gastrointestinal bleeding, including obscure gastrointestinal bleeding (OGIB), which is often recurrent and linked to high morbidity and mortality.
This single-center, prospective, randomized pilot study aims to assess the feasibility and safety of two different management strategies for patients on antithrombotic therapy presenting with OGIB. Approximately 20 participants will be randomized in a 1:1 ratio into two groups:
Group A will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or intravenous) or blood transfusions as needed.
Group B will receive a single round of gastrointestinal evaluation, iron supplementation or transfusions as needed, and regular laboratory monitoring (hemoglobin and ferritin levels).
The primary objective is to evaluate the feasibility of conducting a larger randomized controlled trial comparing conservative medical management to standard repeated endoscopic evaluation. The secondary objective is to compare the quality of life between the two groups.
This study will also assess recruitment strategies, measurement tools, and the safety of a "watchful waiting" approach. Ultimately, the findings will help determine whether endoscopic evaluation provides clinical benefit in patients with iron-deficiency anemia on antithrombotic therapy who have had negative initial endoscopic workups. Currently, there are no established guidelines for managing recurrent iron-deficiency anemia in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Endoscopic Evaluation | Active comparator | Procedure: Standard endoscopic evaluationParticipants will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or IV) or blood transfusions as needed. |
| Conservative Medical Management | Experimental | Procedure: Conservative Medical ManagementParticipants will receive a single round of gastrointestinal evaluation, iron supplementation (oral or IV) or blood transfusions as needed, and regular lab monitoring (hemoglobin and ferritin levels). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult men and postmenopausal women with iron deficiency anemia, and premenopausal women with iron deficiency anemia and a negative gynecological evaluation;
- Patients receiving anticoagulant or antiplatelet therapy
- Negative esophagogastroduodenoscopy (EGD), colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to study enrollment
- Willing and able to provide written informed consent
- Able to read and understand French
Key exclusion criteria (8 listed)
- Ongoing overt gastrointestinal bleeding
- Acute coronary syndrome, acute neurological event, sepsis, or respiratory failure within the past week
- Pregnant women
- Known gastrointestinal or hematological malignancy
- Contraindications to capsule endoscopy
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 |
|---|---|---|
| Standard endoscopic evaluationExaminations of the gastrointestinal (GI) tract (including the stomach, small intestine, and colon) will be performed to identify the source of bleeding. These examinations may be repeated based on the treating physician's assessment. Iron supplementation (ferrous sulfate) will be administered either orally (per os) or intravenously (IV), and blood transfusions will be provided if necessary. | Procedure or surgery | Standard Endoscopic Evaluation |
| Conservative Medical ManagementThe investigational intervention involves a conservative treatment approach guided by a decision-making algorithm based on iron deficiency anemia values. This algorithm, developed from guidelines by the British Society of Gastroenterology and the American Gastroenterological Association, determines whether patients receive oral or IV ferrous sulfate or a blood transfusion. Laboratory parameters (hemoglobin, ferritin) will be monitored at weeks 4, 12, 38, and 64. After iron therapy, hemoglobin response will be assessed at 4 weeks, and treatment will continue for ~3 months post-normalization to ensure iron store repletion. Blood tests will be repeated every 6 months to detect recurrence. | Procedure or surgery | Conservative Medical Management |
Primary outcome
Feasibility of Participant Enrollment
Time frame: 64 weeks
This will be evaluated by the : - Proportion of eligible participants who consent and receive the allocated intervention; - Proportion of treated participants who complete both laboratory tests and the quality-of-life questionnaire twice during the study period.
Hemoglobin level
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hemoglobin
Hematocrit level
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hematocrit
Ferritin
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of ferritin
Reticulocyte count
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of Reticulocyte count
Serum iron
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of serum level
Transferrin saturation
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Relative change of transferrin saturation
Total number of blood transfusions
Time frame: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of all blood transfusion events administered to a participant during the study period.
Total number of dose of ferrous sulfate administered
Time frame: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of individual doses of ferrous sulfate given to a participant during the study period
Adverse Events Reporting
Time frame: Continuously monitored and recorded throughout the 12-month follow-up period
Adverse events will be documented in the case report form (CRF). Events will be classified as serious or non-serious. A serious adverse event is defined as any event resulting in hospitalization, including death from any cause, cardiovascular events related to anemia, or the occurrence of active bleeding. The need to discontinue antithrombotic therapy due to persistent anemia will also be recorded.
2 secondary outcomes
Endoscopic Investigations and Diagnoses in the Standard Care Group
Time frame: Throughout the 12-month follow-up period
Quality of Life Assessment (GIQLI)
Time frame: At baseline and at week 64 (end of study)
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 28 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Éva Mathieu, PhD study director
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard endoscopic evaluation and Conservative Medical Management in people with Obscure Gastrointestinal Bleeding and Iron-Deficiency Anemia, run by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec at 1 site in Canada.
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 6 inclusion and 8 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 28 Jul 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 Canada. 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 Marie-Claude Lehoux, Master (819 697-3333 ext. 60753, marie-claude.lehoux@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Participant Enrollment (time frame: 64 weeks). The study lists 10 primary outcomes in all. 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 28 Jul 2025.