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.
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
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
Parallel
Standard endoscopic evaluation
Procedure/SurgeryExaminations 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 Management
Procedure/SurgeryThe 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.
Hemoglobin level
Relative change of hemoglobin
Hematocrit level
Relative change of hematocrit
Ferritin
Relative change of ferritin
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.
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.
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