An interventional study of Standard endoscopic evaluation and Conservative Medical Management in Obscure Gastrointestinal Bleeding, Iron-Deficiency Anemia and Antithrombotic Therapy, sponsored by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec · Not applicable, Interventional, and Treatment
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.
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult men and postmenopausal women with iron deficiency anemia, and premenopausal women with iron deficiency anemia and a negative gynecological evaluation;
a. Laboratory-confirmed iron deficiency anemia (hemoglobin \< 120 g/L for women, \< 130 g/L for men, and ferritin \< 30 ng/L);
Exclusion Criteria:
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.
Procedure: Standard endoscopic evaluation
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).
Procedure: Conservative Medical Management
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.
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.
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.
Time frame: 64 weeks
Hemoglobin level
Relative change of hemoglobin
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Hematocrit level
Relative change of hematocrit
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Ferritin
Relative change of ferritin
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Reticulocyte count
Relative change of Reticulocyte count
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Serum iron
Relative change of serum level
Time frame: At weeks 4, 12, 38, and 64 following enrollment
Transferrin saturation
Relative change of transferrin saturation
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Continuously monitored and recorded throughout the 12-month follow-up period
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.
Time frame: 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.
Time frame: At baseline and at week 64 (end of study)
Plan to share: No
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Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec