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Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

RecruitingNAAges 18 Years - 90 YearsAllCentre intégré universitaire de santé et de servi…
NCT07089030 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Standard endoscopic evaluation
  • Conservative Medical Management
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Where

1 site
Centre hospitalier affilié universitaire régional de Trois-Rivières
Trois-Rivières, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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