RecruitingNot ApplicableNCT07089030

Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy

Sponsor

Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Enrollment

20 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Obscure gastrointestinal bleeding Iron-Deficiency Anemia Antithrombotic Therapy

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

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);
Patients receiving anticoagulant or antiplatelet therapy
Negative esophagogastroduodenoscopy (EGD), colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to study enrollment
Willing and able to provide written informed consent
Able to read and understand French

Exclusion Criteria8

Ongoing overt gastrointestinal bleeding
Acute coronary syndrome, acute neurological event, sepsis, or respiratory failure within the past week
Pregnant women
Known gastrointestinal or hematological malignancy
Contraindications to capsule endoscopy
History of bariatric surgery, gastrectomy, or segmental resection of the small intestine
Inability to take oral iron
Other sources of blood loss (e.g., urinary, gynecological, hematoma, hemolysis)

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Interventions

PROCEDUREStandard 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.

PROCEDUREConservative 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.