Actively Recruiting
A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
Led by Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec · Updated on 2025-07-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two different management strategies for patients on antithrombotic therapy who experience obscure gastrointestinal bleeding (OGIB) and iron-deficiency anemia. The study focuses on comparing repeated endoscopic evaluations to a conservative medical approach with limited testing. This pilot, randomized study seeks to understand the feasibility and safety of these approaches and to inform future larger trials due to the current lack of guidelines for managing recurrent iron-deficiency anemia in this population. Participants will be randomly assigned to one of two groups. One group will receive repeated gastrointestinal examinations, such as endoscopy, colonoscopy, and capsule endoscopy, alongside iron supplementation either orally or intravenously and blood transfusions if needed. The other group will undergo a single gastrointestinal evaluation combined with iron supplementation or transfusions as required and regular blood tests to monitor hemoglobin and ferritin levels over time. Treatment decisions in the conservative group follow a specific algorithm based on anemia values. During the 12-month study period, participants will have assessments including blood tests at weeks 4, 12, 38, and 64 to measure hemoglobin, hematocrit, ferritin, reticulocyte count, serum iron, and transferrin saturation. Researchers will track the number of blood transfusions and iron doses given, monitor adverse events continuously, and evaluate quality of life at the start and end of the study. The study also reviews the safety of watchful waiting and measures clinical outcomes to compare the two management strategies.
CONDITIONS
Brief Title
Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and postmenopausal women with iron deficiency anemia
- Premenopausal women with iron deficiency anemia and a negative gynecological evaluation
- 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, colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to enrollment
- Willing and able to provide written informed consent
- Able to read and understand French
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 64 weeks
Participants receive either repeated gastrointestinal evaluations and iron supplementation or a single gastrointestinal evaluation with regular laboratory monitoring and iron supplementation, depending on their assigned group.
Visits at weeks 4, 12, 38, and 64 for laboratory monitoring and assessments; additional visits for repeated endoscopic evaluations as clinically indicated in the standard care group
Duration - 12 months
Participants are monitored for adverse events and quality of life assessments throughout the 12-month follow-up period after treatment initiation.
Continuous monitoring with quality of life assessments at baseline and week 64
Trial Site Locations
Total: 1 location
1
Centre hospitalier affilié universitaire régional de Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
Research Team
M
Marie-Claude Lehoux, Master
É
Éva Mathieu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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