The NoPac study: Investigating a new treatment to help control nose bleeds
- Conditions
- Atraumatic epistaxisMedDRA version: 20.0Level: PTClassification code 10015090Term: EpistaxisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2016-001530-10-GB
- Lead Sponsor
- Royal Devon & Exeter NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Potential participants must satisfy the following criteria to be enrolled in the study:
• Aged 18 or over
• Presenting to the ED with spontaneous, atraumatic epistaxis, unresolved with simple first aid and standard initial therapy.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250
Potential participants meeting any of the following criteria will be excluded from study participation:
• Clinical evidence of shock, as determined by the treating clinician, or requirement for resuscitation (including but not limited to systolic BP< 90 mmHg).
• Known allergy to TXA
• Lacking capacity
• Unwilling to give consent
• No telephone or unwilling to be contacted by telephone
• Known paranasal, nasopharyngeal or nasal cavity malignancy
• Pregnancy
• Sent to ED for specialist ENT treatment
• Already undergone pre-hospital nasal packing
• Prior participation in the study (i.e. received allocated treatment)
• Prisoners
• Epistaxis caused by trauma (excluding simple nose picking)
• Known haemophilia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method