Pilot Study Comparing Endoscopic Versus Medical Management for Iron Deficiency Anemia in Patients on Antithrombotic Therapy

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.

Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy