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Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

NCT07089030 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

  • Obscure Gastrointestinal Bleeding
  • Iron-Deficiency Anemia
  • Antithrombotic Therapy

Interventions

PROCEDURE

Standard 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.

PROCEDURE

Conservative 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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Éva Mathieu, PhD · Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2026-06-06
Completion
2026-06-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089030 on ClinicalTrials.gov