Status:
RECRUITING
Medico-economic Evaluation of Management Strategies for Severe Epistaxis
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Epistaxis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Current recommendations consider surgical ligation and supra-selective embolization as equivalent in terms of efficacy and there is no clear consensus to choose between one and the other technique. In...
Detailed Description
The hypothesis is that early ligation of the sphenopalatine arteries would reduce the costs of care for the community while improving the quality of life of patients compared to supra-elective emboliz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05281952
Start Date
May 1 2023
End Date
December 1 2026
Last Update
August 29 2023
Active Locations (1)
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1
University Hospital
Toulouse, France