Standard endoscopic evaluationConservative Medical Management
Standard endoscopic evaluation: 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 Management: 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 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). 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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);
2. Patients receiving anticoagulant or antiplatelet therapy
3. Negative esophagogastroduodenoscopy (EGD), colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to study enrollment
4. Willing and able to provide written informed consent
5. Able to read and understand French
Exclusion Criteria:
1. Ongoing overt gastrointestinal bleeding
2. Acute coronary syndrome, acute neurological event, sepsis, or respiratory failure within the past week
3. Pregnant women
4. Known gastrointestinal or hematological malignancy
5. Contraindications to capsule endoscopy
6. History of bariatric surgery, gastrectomy, or segmental resection of the small intestine
7. Inability to take oral iron
8. Other sources of blood loss (e.g., urinary, gynecological, hematoma, hemolysis)
Primary outcome measure(s)
Feasibility of Participant Enrollment — 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 — At weeks 4, 12, 38, and 64 following enrollment Relative change of hemoglobin
Hematocrit level — At weeks 4, 12, 38, and 64 following enrollment Relative change of hematocrit
Ferritin — At weeks 4, 12, 38, and 64 following enrollment Relative change of ferritin
Reticulocyte count — At weeks 4, 12, 38, and 64 following enrollment Relative change of Reticulocyte count
Serum iron — At weeks 4, 12, 38, and 64 following enrollment Relative change of serum level
Transferrin saturation — At weeks 4, 12, 38, and 64 following enrollment Relative change of transferrin saturation
Total number of blood transfusions — 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 — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Centre hospitalier affilié universitaire régional de Trois-Rivières
Trois-Rivières
Quebec
Recruiting
More Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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