Endoscopic versus conservative management of iron-deficiency anemia in patients on blood thinners

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized pilot assigns about 20 adults on anticoagulant or antiplatelet therapy with obscure GI bleeding to either repeated endoscopic evaluations as needed or a conservative approach with a single evaluation and regular lab monitoring. Participants in both arms receive iron supplementation or transfusions as clinically required. The primary goal is to determine feasibility and safety to inform a larger randomized trial, and a secondary goal is to compare quality of life between the approaches. The study requires prior negative EGD, colonoscopy, and capsule endoscopy within six months and French language ability for consent and follow-up.

Why it matters

Who can join: the full rules

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)

Where it's running

• Centre hospitalier affilié universitaire régional de Trois-Rivières
  Trois-Rivières, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Marie-Claude Lehoux, Master
• Email: marie-claude.lehoux@ssss.gouv.qc.ca
• Phone: 819 697-3333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.