EUCTR2016-001530-10-GB
Active, not recruiting
Phase 1
A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis. - Novel use of TXA to reduce the need for nasal packing in epistaxis
ConditionsAtraumatic 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]
DrugsTranexamic Acid
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atraumatic epistaxis
- Sponsor
- Royal Devon & Exeter NHS Foundation Trust
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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