Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard endoscopic evaluation, Conservative Medical Management.
- Who it may be relevant to
- Registry conditions: Obscure Gastrointestinal Bleeding, Iron-Deficiency Anemia, Antithrombotic Therapy. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
Overview
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.
Detailed description
Antithrombotic therapy plays a critical role in preventing thrombotic events in patients with atherosclerotic coronary artery disease and atrial fibrillation. However, these therapies are associated with an increased risk of gastrointestinal bleeding, including obscure gastrointestinal bleeding (OGIB), which is often recurrent and linked to high morbidity and mortality.
This single-center, prospective, randomized pilot study aims to assess the feasibility and safety of two different management strategies for patients on antithrombotic therapy presenting with OGIB. Approximately 20 participants will be randomized in a 1:1 ratio into two groups:
Group A will undergo repeated gastrointestinal evaluations (e.g., endoscopy, colonoscopy, capsule endoscopy) as clinically indicated, along with iron supplementation (oral or intravenous) or blood transfusions as needed.
Group B will receive a single round of gastrointestinal evaluation, iron supplementation or transfusions as needed, and regular laboratory monitoring (hemoglobin and ferritin levels).
The primary objective is to evaluate the feasibility of conducting a larger randomized controlled trial comparing conservative medical management to standard repeated endoscopic evaluation. The secondary objective is to compare the quality of life between the two groups.
This study will also assess recruitment strategies, measurement tools, and the safety of a "watchful waiting" approach. Ultimately, the findings will help determine whether endoscopic evaluation provides clinical benefit in patients with iron-deficiency anemia on antithrombotic therapy who have had negative initial endoscopic workups. Currently, there are no established guidelines for managing recurrent iron-deficiency anemia in this population.
Interventions
- Procedure Standard endoscopic evaluation
Examinations of the gastrointestinal (GI) tract (including the stomach, small intestine, and colon) will be performed to identify the source of bleeding. These examinations may be repeated based on the treating physician's assessment. Iron supplementation (ferrous sulfate) will be administered either orally (per os) or intravenously (IV), and blood transfusions will be provided if necessary. - Procedure Conservative Medical Management
The investigational intervention involves a conservative treatment approach guided by a decision-making algorithm based on iron deficiency anemia values. This algorithm, developed from guidelines by the British Society of Gastroenterology and the American Gastroenterological Association, determines whether patients receive oral or IV ferrous sulfate or a blood transfusion. Laboratory parameters (hemoglobin, ferritin) will be monitored at weeks 4, 12, 38, and 64. After iron therapy, hemoglobin re
Primary outcome measures
- Feasibility of Participant Enrollment [Time frame: 64 weeks]
- Hemoglobin level [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Hematocrit level [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Ferritin [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Reticulocyte count [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Serum iron [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Transferrin saturation [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Total number of blood transfusions [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Total number of dose of ferrous sulfate administered [Time frame: At weeks 4, 12, 38, and 64 following enrollment]
- Adverse Events Reporting [Time frame: Continuously monitored and recorded throughout the 12-month follow-up period]
Secondary outcome measures (2)
- Endoscopic Investigations and Diagnoses in the Standard Care Group [Time frame: Throughout the 12-month follow-up period]
- Quality of Life Assessment (GIQLI) [Time frame: At baseline and at week 64 (end of study)]
Eligibility criteria
Inclusion criteria
- 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
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre hospitalier affilié universitaire régional de Trois-Rivières — Trois-Rivières
Identifiers
NCT: NCT07089030 · 2023-708