Recruiting

Conservative Management & Endoscopy

Sponsor:

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

Code:

NCT07089030

Conditions

Obscure Gastrointestinal Bleeding

Iron-Deficiency Anemia

Antithrombotic Therapy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard endoscopic evaluation

Conservative Medical Management

Study Details

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.

Conditions

Obscure Gastrointestinal Bleeding

Iron-Deficiency Anemia

Antithrombotic Therapy

Study ID

NCT07089030

Start date

Jun 6, 2023

Status verified date

Jul, 2025

Completion date

Jun 6, 2026

Anticipated

Primary completion date

Jun 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Endoscopic Evaluation

Participants will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or IV) or blood transfusions as needed.

experimental: Conservative Medical Management

Participants will receive a single round of gastrointestinal evaluation, iron supplementation (oral or IV) or blood transfusions as needed, and regular lab monitoring (hemoglobin and ferritin levels).

Interventions

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.

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.

Primary outcome measure

  • Feasibility of Participant Enrollment [ Time Frame: 64 weeks ]
  • Hemoglobin level [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Hematocrit level [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Ferritin [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Reticulocyte count [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Serum iron [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Transferrin saturation [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Total number of blood transfusions [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Total number of dose of ferrous sulfate administered [ Time Frame: At weeks 4, 12, 38, and 64 following enrollment ]
  • Adverse Events Reporting [ Time Frame: Continuously monitored and recorded throughout the 12-month follow-up period ]

Central Contacts and Locations

Central contacts

Marie-Claude Lehoux, Master

819 697-3333marie-claude.lehoux@ssss.gouv.qc.ca

Éva Mathieu, PhD

819-697-3333eva.mathieu@ssss.gouv.qc.ca

Locations

Centre hospitalier affilié universitaire régional de Trois-Rivières

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Éva Mathieu, PhD

819-697-3333eva.mathieu@ssss.gouv.qc.ca

Principal Investigator:

Camille Abi-Raad, MD

More Information

Sponsor

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

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • Obscure Gastrointestinal Bleeding
  • Iron-Deficiency Anemia
  • Antithrombotic Therapy
  • Anticoagulants
  • Antiplatelet Agents
  • Endoscopy
  • Gastrointestinal Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec on 2025-07-28.