Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy (NCT07089030) | Clinical Trial Compass
RecruitingNot Applicable
Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy
Canada20 participantsStarted 2023-06-06
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult men and postmenopausal women with iron deficiency anemia, and premenopausal women with iron deficiency anemia and a negative gynecological evaluation;
. 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
Exclusion criteria
. Ongoing overt gastrointestinal bleeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Participant Enrollment
Timeframe: 64 weeks
2
Hemoglobin level
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
3
Hematocrit level
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
4
Ferritin
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
5
Reticulocyte count
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
6
Serum iron
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
7
Transferrin saturation
Timeframe: At weeks 4, 12, 38, and 64 following enrollment
8
Total number of blood transfusions
Trial details
NCT IDNCT07089030
SponsorCentre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec