Evaluating treatment options for severe nosebleeds
Medico-economic Evaluation of Management Strategies for Severe Epistaxis
This study tests two different ways to treat severe nosebleeds to see which one is better for patients and costs less.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05281952 on ClinicalTrials.gov |
What this trial studies
This study compares two management strategies for severe epistaxis: endoscopic ligation and supra-selective embolization. It aims to determine which method is more cost-effective while also improving patient quality of life. The research will assess factors such as recurrence rates, hospital stay lengths, and postoperative care costs. By randomizing patients who have not responded to initial treatments, the study seeks to provide clearer guidelines for managing severe nosebleeds.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe epistaxis that has not improved after 48 hours of double tamponade treatment.
Not a fit: Patients with epistaxis due to trauma, malignancies, or those who have previously undergone ligation or embolization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and economical treatment options for patients suffering from severe epistaxis.
How similar studies have performed: While there is limited data on the economic evaluation of these specific techniques, similar studies in other areas of surgical management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with severe epistaxis who failed treatment with double tamponade for more than 48 hours. * Patient over 18 years old * Affiliated patient or beneficiary of a social security scheme. * Patient accepting the principle of randomization * Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patient with epistaxis secondary to facial and/or surgical trauma. * Patient with epistaxis related to a malignant tumor cause * Patient with a history of ligation or embolization * Patient under legal protection and/or curatorship and/or guardianship. * Impossibility of giving the person informed information and ensuring the subject's compliance due to impaired physical and/or psychological health. * Patient participating in another research including an exclusion period still in progress * Pregnant or breastfeeding patient For non randomized patient * Patient with a contraindication to general anesthesia: severe and/or decompensated cardiac/hepatic/renal insufficiency, ASA score 4 * Severe hemostasis disorders that cannot benefit from correction. * History of transient and/or definitive stroke of the ischemic type * Atheromatous overload
Where this trial is running
Toulouse
- University Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Guillaume DE BONNECAZE, MD — University Hospital, Toulouse
- Study coordinator: Guillaume DE BONNECAZE, MD
- Email: debonnecaze.g@chu-toulouse.fr
- Phone: 0567771641
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.