Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

Not Applicable

Recruiting

• Conditions: Obscure Gastrointestinal Bleeding; Iron-Deficiency Anemia; Antithrombotic Therapy

• Registration Number: NCT07089030
• Lead Sponsor: Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

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.

Detailed Description

Antithrombotic therapy plays a critical role in preventing thrombotic events in patients with atherosclerotic coronary artery disease and atrial fibrillation. However, these therapies are associated with an increased risk of gastrointestinal bleeding, including obscure gastrointestinal bleeding (OGIB), which is often recurrent and linked to high morbidity and mortality.

This single-center, prospective, randomized pilot study aims to assess the feasibility and safety of two different management strategies for patients on antithrombotic therapy presenting with OGIB. Approximately 20 participants will be randomized in a 1:1 ratio into two groups:

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

Group B will receive a single round of gastrointestinal evaluation, iron supplementation or transfusions as needed, and regular laboratory monitoring (hemoglobin and ferritin levels).

The primary objective is to evaluate the feasibility of conducting a larger randomized controlled trial comparing conservative medical management to standard repeated endoscopic evaluation. The secondary objective is to compare the quality of life between the two groups.

This study will also assess recruitment strategies, measurement tools, and the safety of a "watchful waiting" approach. Ultimately, the findings will help determine whether endoscopic evaluation provides clinical benefit in patients with iron-deficiency anemia on antithrombotic therapy who have had negative initial endoscopic workups. Currently, there are no established guidelines for managing recurrent iron-deficiency anemia in this population.

Study Timeline

• Study Start: 2023-06-06
• Status Verified: 2025-07
• Study First Submitted: 2025-07-18
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2026-06-06
• Study Completion: 2026-06-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of Participant Enrollment	64 weeks	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.
Hemoglobin level	At weeks 4, 12, 38, and 64 following enrollment	Relative change of hemoglobin
Hematocrit level	At weeks 4, 12, 38, and 64 following enrollment	Relative change of hematocrit
Ferritin	At weeks 4, 12, 38, and 64 following enrollment	Relative change of ferritin
Reticulocyte count	At weeks 4, 12, 38, and 64 following enrollment	Relative change of Reticulocyte count
Serum iron	At weeks 4, 12, 38, and 64 following enrollment	Relative change of serum level
Transferrin saturation	At weeks 4, 12, 38, and 64 following enrollment	Relative change of transferrin saturation
Total number of blood transfusions	At weeks 4, 12, 38, and 64 following enrollment	The cumulative count of all blood transfusion events administered to a participant during the study period.
Total number of dose of ferrous sulfate administered	At weeks 4, 12, 38, and 64 following enrollment	The cumulative count of individual doses of ferrous sulfate given to a participant during the study period
Adverse Events Reporting	Continuously monitored and recorded throughout the 12-month follow-up period	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.

Secondary Outcome Measures

Name	Time	Method
Endoscopic Investigations and Diagnoses in the Standard Care Group	Throughout the 12-month follow-up period	For participants in the standard care group, all endoscopic procedures performed (e.g., upper endoscopy, colonoscopy, capsule endoscopy) and any resulting diagnoses will be recorded. This information will be used to characterize the diagnostic yield and clinical management in the standard intervention arm.
Quality of Life Assessment (GIQLI)	At baseline and at week 64 (end of study)	Quality of life will be assessed using the Gastrointestinal Quality of Life Index (GIQLI), a validated 36-item questionnaire developed in Germany. It includes five subscales: gastrointestinal symptoms, emotional well-being, physical function, social function, and medical treatment. Each item is scored from 0 to 4, with a total score ranging from 0 to 144. Higher scores indicate better quality of life. The validated French version of the GIQLI (Slim et al., 1999) will be used in this study. Completion time is approximately 20 minutes.

Trial Locations

Locations (1)

Centre hospitalier affilié universitaire régional de Trois-Rivières; 🇨🇦 Trois-Rivières, Quebec, Canada