A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of Participant Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Feasibility of Participant Enrollment
时间窗: 64 weeks
This will be evaluated by the : - Proportion of eligible participants who consent and receive the allocated intervention; - Proportion of treated participants who complete both laboratory tests and the quality-of-life questionnaire twice during the study period.
Hemoglobin level
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hemoglobin
Hematocrit level
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hematocrit
Ferritin
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of ferritin
Reticulocyte count
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of Reticulocyte count
Serum iron
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of serum level
Transferrin saturation
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of transferrin saturation
Total number of blood transfusions
时间窗: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of all blood transfusion events administered to a participant during the study period.
Total number of dose of ferrous sulfate administered
时间窗: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of individual doses of ferrous sulfate given to a participant during the study period
Adverse Events Reporting
时间窗: Continuously monitored and recorded throughout the 12-month follow-up period
Adverse events will be documented in the case report form (CRF). Events will be classified as serious or non-serious. A serious adverse event is defined as any event resulting in hospitalization, including death from any cause, cardiovascular events related to anemia, or the occurrence of active bleeding. The need to discontinue antithrombotic therapy due to persistent anemia will also be recorded.
Feasibility of Participant Enrollment
时间窗: 64 weeks
This will be evaluated by the : - Proportion of eligible participants who consent and receive the allocated intervention; - Proportion of treated participants who complete both laboratory tests and the quality-of-life questionnaire twice during the study period.
Hemoglobin level
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hemoglobin
Hematocrit level
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of hematocrit
Ferritin
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of ferritin
Reticulocyte count
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of Reticulocyte count
Serum iron
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of serum level
Transferrin saturation
时间窗: At weeks 4, 12, 38, and 64 following enrollment
Relative change of transferrin saturation
Total number of blood transfusions
时间窗: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of all blood transfusion events administered to a participant during the study period.
Total number of dose of ferrous sulfate administered
时间窗: At weeks 4, 12, 38, and 64 following enrollment
The cumulative count of individual doses of ferrous sulfate given to a participant during the study period
Adverse Events Reporting
时间窗: Continuously monitored and recorded throughout the 12-month follow-up period
Adverse events will be documented in the case report form (CRF). Events will be classified as serious or non-serious. A serious adverse event is defined as any event resulting in hospitalization, including death from any cause, cardiovascular events related to anemia, or the occurrence of active bleeding. The need to discontinue antithrombotic therapy due to persistent anemia will also be recorded.
次要结局
- Endoscopic Investigations and Diagnoses in the Standard Care Group(Throughout the 12-month follow-up period)
- Quality of Life Assessment (GIQLI)(At baseline and at week 64 (end of study))
- Endoscopic Investigations and Diagnoses in the Standard Care Group(Throughout the 12-month follow-up period)
- Quality of Life Assessment (GIQLI)(At baseline and at week 64 (end of study))
研究者
Marie-Claude Lehoux
Principal Investigator
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec