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 range18 Years – 90 Years
SexALL
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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
✕. 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
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
Timeframe: At weeks 4, 12, 38, and 64 following enrollment