Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

NCT07089030 | Recruiting

• 1 other identifier: 2023-708
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Feasibility of Participant Enrollment

  This will be evaluated by the : \- Proportion of eligible participants who consent and receive the allocated intervention; - Proportion of treated participants who complete both laboratory tests and the quality-of-life questionnaire twice during the study period.

  64 weeks

• Hemoglobin level

  Relative change of hemoglobin

  At weeks 4, 12, 38, and 64 following enrollment

• Hematocrit level

  Relative change of hematocrit

  At weeks 4, 12, 38, and 64 following enrollment

• Ferritin

  Relative change of ferritin

  At weeks 4, 12, 38, and 64 following enrollment

• Reticulocyte count

  Relative change of Reticulocyte count

  At weeks 4, 12, 38, and 64 following enrollment

• Serum iron

  Relative change of serum level

  At weeks 4, 12, 38, and 64 following enrollment

• Transferrin saturation

  Relative change of transferrin saturation

  At weeks 4, 12, 38, and 64 following enrollment

• Total number of blood transfusions

  The cumulative count of all blood transfusion events administered to a participant during the study period.

  At weeks 4, 12, 38, and 64 following enrollment

• Total number of dose of ferrous sulfate administered

  The cumulative count of individual doses of ferrous sulfate given to a participant during the study period

  At weeks 4, 12, 38, and 64 following enrollment

• Adverse Events Reporting

  Adverse events will be documented in the case report form (CRF). Events will be classified as serious or non-serious. A serious adverse event is defined as any event resulting in hospitalization, including death from any cause, cardiovascular events related to anemia, or the occurrence of active bleeding. The need to discontinue antithrombotic therapy due to persistent anemia will also be recorded.

  Continuously monitored and recorded throughout the 12-month follow-up period

Secondary Outcomes (2)

• Endoscopic Investigations and Diagnoses in the Standard Care Group

  Throughout the 12-month follow-up period

• Quality of Life Assessment (GIQLI)

  At baseline and at week 64 (end of study)

Study Arms (2)

Standard Endoscopic Evaluation

ACTIVE COMPARATOR

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.

Procedure: Standard endoscopic evaluation

Conservative Medical Management

EXPERIMENTAL

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).

Procedure: Conservative Medical Management

Interventions

Standard endoscopic evaluation PROCEDURE

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.

Standard Endoscopic Evaluation

Conservative Medical Management PROCEDURE

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.

Conservative Medical Management

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Centre hospitalier affilié universitaire régional de Trois-Rivières

Trois-Rivières, Quebec, G8Z 3R9, Canada

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Éva Mathieu, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Marie-Claude Lehoux, Master

CONTACT

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

Éva Mathieu, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 28, 2025
• Study Start: June 6, 2023
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)