[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599787":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Endoscopic Evaluation","ACTIVE_COMPARATOR","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.",[13],"Procedure: Standard endoscopic evaluation",{"label":15,"type":16,"description":17,"interventionNames":18},"Conservative Medical Management","EXPERIMENTAL","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).",[19],"Procedure: Conservative Medical Management",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"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 response will be assessed at 4 weeks, and treatment will continue for \\~3 months post-normalization to ensure iron store repletion. Blood tests will be repeated every 6 months to detect recurrence.",[15],[31],{"name":32,"affiliation":5,"role":33},"Éva Mathieu, PhD","STUDY_DIRECTOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Marie-Claude Lehoux, Master","CONTACT","819 697-3333","60753","marie-claude.lehoux@ssss.gouv.qc.ca",{"name":32,"role":37,"phone":42,"phoneExt":43,"email":44},"819-697-3333","60756","eva.mathieu@ssss.gouv.qc.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Centre hospitalier affilié universitaire régional de Trois-Rivières","RECRUITING","Trois-Rivières","Quebec","G8Z 3R9","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-72.5477,46.34515,{"lat":58,"lon":57},[61,62],{"name":32,"role":37,"phone":42,"phoneExt":43,"email":44},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Camille Abi-Raad, MD","PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Marie-Claude Lehoux","Principal Investigator","100599787","endoscopic-evaluation-for-iron-deficiency-anemia-in-patients-on-antithrombotic-therapy-100599787",false,"NCT07089030","Endoscopic Evaluation for Iron Deficiency Anemia in Patients on Antithrombotic Therapy","A Pilot Study Evaluating the Benefit of Endoscopic Assessment for Iron Deficiency Anemia in Patients Receiving Antithrombotic Therapy","BEACON-IDA","Inclusion Criteria:\n\n1. Adult men and postmenopausal women with iron deficiency anemia, and premenopausal women with iron deficiency anemia and a negative gynecological evaluation;\n\n   a. Laboratory-confirmed iron deficiency anemia (hemoglobin \\\u003C 120 g\u002FL for women, \\\u003C 130 g\u002FL for men, and ferritin \\\u003C 30 ng\u002FL);\n2. Patients receiving anticoagulant or antiplatelet therapy\n3. Negative esophagogastroduodenoscopy (EGD), colonoscopy, and capsule endoscopy for gastrointestinal bleeding within six months prior to study enrollment\n4. Willing and able to provide written informed consent\n5. Able to read and understand French\n\nExclusion Criteria:\n\n1. Ongoing overt gastrointestinal bleeding\n2. Acute coronary syndrome, acute neurological event, sepsis, or respiratory failure within the past week\n3. Pregnant women\n4. Known gastrointestinal or hematological malignancy\n5. Contraindications to capsule endoscopy\n6. History of bariatric surgery, gastrectomy, or segmental resection of the small intestine\n7. Inability to take oral iron\n8. Other sources of blood loss (e.g., urinary, gynecological, hematoma, hemolysis)","ALL","18 Years","90 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"NA","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.",[87,88,89],"Obscure Gastrointestinal Bleeding","Iron-Deficiency Anemia","Antithrombotic Therapy",[87,88,89,91,92,93,94],"Anticoagulants","Antiplatelet Agents","Endoscopy","Gastrointestinal Hemorrhage","2025-07-25",{"date":97,"type":98},"2025-07-28","ACTUAL",{"date":100,"type":98},"2023-06-06",{"date":102,"type":81},"2026-06-06",{"name":5,"class":6},1]