Endoscopic Evaluation for Iron-Deficiency Anemia
(BEACON-IDA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to manage iron-deficiency anemia in individuals on blood thinners with unexplained gastrointestinal bleeding. Participants will either undergo repeated endoscopies (a procedure to examine the digestive tract) or follow a more conservative medical management approach with fewer tests and regular lab checks. The goal is to determine if less frequent testing can still ensure good health outcomes and quality of life. This trial may suit adults with iron-deficiency anemia who have a history of negative tests for gastrointestinal bleeding and are currently taking blood thinners. As an unphased study, this trial offers a unique opportunity to contribute to research that may enhance anemia management strategies.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, since it involves patients on antithrombotic therapy, you may be required to continue those medications.
What prior data suggests that these management strategies are safe for patients with OGIB?
Research has shown that intravenous iron therapy, a key component of conservative medical care, is generally safe. A review of studies found that patients receiving intravenous iron experienced positive safety outcomes, even when considering the risk of death over a year, indicating that the treatment is often well-tolerated.
This conservative approach also includes regular lab tests and iron supplements, administered orally or through an IV as needed. These methods are commonly used and generally safe. However, like any treatment, some individuals might experience side effects. Most patients do well with the regular monitoring and adjustments integral to this management strategy.12345Why are researchers excited about this trial?
Researchers are excited about the endoscopic evaluation protocol for iron-deficiency anemia because it streamlines the diagnostic process. Unlike the standard approach, which involves repeated endoscopic evaluations over time, this trial explores the impact of a single comprehensive evaluation paired with conservative management strategies. This method potentially reduces the number of invasive procedures patients undergo, focusing instead on regular lab monitoring and timely interventions like iron supplementation or blood transfusions. By simplifying the evaluation process, this approach could enhance patient comfort and improve adherence to treatment plans.
What evidence suggests that this trial's management strategies could be effective for iron-deficiency anemia?
This trial will compare two approaches for managing iron-deficiency anemia: Standard Endoscopic Evaluation and Conservative Medical Management. Studies have shown that intravenous iron, which participants in both arms may receive as part of their treatment, effectively treats iron-deficiency anemia, especially when oral iron proves insufficient. Research indicates that intravenous iron improves hemoglobin levels, increasing red blood cells more effectively and reducing the need for blood transfusions. Most patients respond well to iron treatments, with many experiencing improvements in iron levels. However, one study noted that some patients may take longer to fully resolve their iron deficiency. Overall, intravenous iron is a strong option for addressing iron-deficiency anemia.34678
Who Is on the Research Team?
Éva Mathieu, PhD
Principal Investigator
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Are You a Good Fit for This Trial?
This trial is for adults with iron deficiency anemia who are on blood thinners, have had negative scopes for GI bleeding in the past 6 months, and can understand French. Premenopausal women must also have a negative gynecological evaluation. Those unable to consent or follow study procedures are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either repeated endoscopic evaluations or a conservative medical approach with limited testing, including iron supplementation or transfusions as needed.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and quality of life assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Conservative Medical Management
- Standard endoscopic evaluation
Trial Overview
The study compares two approaches for patients with obscure GI bleeding on antithrombotic therapy: repeated endoscopic exams versus conservative medical management. It aims to see if less invasive treatment leads to similar health outcomes as standard procedures.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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).
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec
Lead Sponsor
Citations
Management of Iron Deficiency Anemia - PMC - PubMed Central
Intravenous Iron. Intravenous iron is very effective in the treatment of iron deficiency anemia68-74 and should be considered when oral iron is ineffective.
Iron deficiency resolution and time to ...
In a statewide cohort, time to resolution of iron deficiency was 1.9 years, and 58% of patients did not achieve resolution within 3 years.
Active Prevention and Treatment of Post–Critical Illness ...
Second, virtually all patients were classed as iron responsive according to the prespecified definition, and 98.0% received the full predefined ...
Iron Supplementation, Response in Iron-Deficiency Anemia
Intravenous iron is more effective than oral iron in pro- ducing sustained hemoglobin responses and reducing the need for blood transfusions.30 Newer ...
Systematic review and meta-analysis of intravenous iron ...
We performed an updated systematic review and meta-analysis to estimate the effect of iv iron on key clinical outcomes in patients with HF and iron deficiency ...
Diagnostic work-up of anemia and associated health ...
Conclusions. One in three patients with HF experienced anemia, which was associated with adverse health outcomes. Testing for iron stores and ...
NCT07089030 | Endoscopic Evaluation for Iron Deficiency ...
The study aims to assess whether conservative management yields similar clinical outcomes and quality of life compared to standard repeated endoscopic ...
8.
medicine.yale.edu
medicine.yale.edu/news-article/why-screen-for-iron-deficiency-its-common-consequential-and-curable/Why Screen for Iron Deficiency? It's Common, Consequential ...
Pregnant women with anemia face greater risk of preeclampsia, preterm birth, and post-partum hemorrhage. Raising the bar for ferritin. The ...
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