NCT07089030 Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy
| NCT ID | NCT07089030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec |
| Condition | Obscure Gastrointestinal Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2026-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-06-06 with a primary completion date of 2026-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Éva Mathieu, PhD
STUDY DIRECTOR
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Frequently Asked Questions
Who can join the NCT07089030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Obscure Gastrointestinal Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07089030 currently recruiting?
Yes, NCT07089030 is actively recruiting participants. Contact the research team at marie-claude.lehoux@ssss.gouv.qc.ca for enrollment information.
Where is the NCT07089030 trial being conducted?
This trial is being conducted at Trois-Rivières, Canada.
Who is sponsoring the NCT07089030 clinical trial?
NCT07089030 is sponsored by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec. The principal investigator is Éva Mathieu, PhD at Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec. The trial plans to enroll 20 participants.