Endoscopic versus conservative management of iron-deficiency anemia in patients on blood thinners
A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
This trial will test whether a conservative medical approach with limited testing works as well as repeated endoscopic exams for people on blood thinners who have recurrent iron-deficiency anemia from obscure gastrointestinal bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec Academic / other |
| Locations | 1 site (Trois-Rivières, Quebec) |
| Trial ID | NCT07089030 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults on anticoagulant or antiplatelet therapy with laboratory-confirmed iron-deficiency anemia, prior negative upper/lower endoscopy and capsule endoscopy within six months, who can read French and provide informed consent are ideal candidates.
Not a fit: Patients with ongoing overt gastrointestinal bleeding, recent acute cardiac or neurological events, pregnancy, known GI or hematologic malignancy, contraindications to capsule endoscopy, or prior major small-bowel surgery are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce the number of repeated invasive endoscopies and their risks for patients on antithrombotic therapy while maintaining clinical outcomes.
How similar studies have performed: There is limited randomized evidence directly comparing conservative monitoring to repeated endoscopic evaluation in this specific population, so this pilot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Trois-Rivières, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.