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A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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);

• 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

Locations
Other Locations
Canada
Centre hospitalier affilié universitaire régional de Trois-Rivières
RECRUITING
Trois-rivières
Contact Information
Primary
Marie-Claude Lehoux, Master
marie-claude.lehoux@ssss.gouv.qc.ca
819 697-3333
Backup
Éva Mathieu, PhD
eva.mathieu@ssss.gouv.qc.ca
819-697-3333
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2026-06-06
Participants
Target number of participants: 20
Treatments
Active_comparator: Standard Endoscopic Evaluation
Participants will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or IV) or blood transfusions as needed.
Experimental: Conservative Medical Management
Participants will receive a single round of gastrointestinal evaluation, iron supplementation (oral or IV) or blood transfusions as needed, and regular lab monitoring (hemoglobin and ferritin levels).
Related Therapeutic Areas
Sponsors
Leads: Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

This content was sourced from clinicaltrials.gov