Effects of anticoagulant interruption and left atrial occlusion in patients with bleeding from radiation cystitis and atrial fibrillation
Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding
This study looks at patients who have bleeding from radiation cystitis while on blood thinners for atrial fibrillation to see how these factors affect their treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT04701749 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a data registry for patients suffering from hematuria due to radiation cystitis who are also undergoing anticoagulation treatment for non-valvular atrial fibrillation. Patients will be recruited after experiencing at least one episode of hematuria while on anticoagulants. The study will involve collecting retrospective data and assessing the potential need for percutaneous left atrial occlusion based on cardiological advice. The goal is to better understand the relationship between anticoagulation, hematuria, and treatment outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with hematuric radiation cystitis who are also receiving anticoagulation for non-valvular atrial fibrillation.
Not a fit: Patients with hematuria from causes other than radiation cystitis or those using antiplatelet agents for reasons unrelated to atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients experiencing hematuria due to radiation cystitis while on anticoagulant therapy.
How similar studies have performed: While there is limited research specifically addressing this combination of conditions, similar studies on anticoagulation management in patients with bleeding complications have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years old benefiting a social security sheme. * Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation. Exclusion Criteria: * All the other hematuria's reasons * Other reason of anti platelet agent using than atrial fibrillation
Where this trial is running
Clermont-Ferrand
- Chu Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Laurent GUY — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.