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Novel use of TXA to reduce the need for nasal packing in epistaxis

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN34153772
Enrollment
450
Registered
2017-06-01
Start date
2017-05-05
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis Signs and Symptoms Epistaxis

Interventions

After written consent has been obtained and eligibility for the study is confirmed, participants will be randomised to receive up to two doses of either topical intranasal TXA or matched placebo. Rand

Sponsors

Royal Devon and Exeter NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 or over, any gender 2. Presenting to the ED with spontaneous, atraumatic epistaxis, unresolved with simple first aid and standard initial therapy

Exclusion criteria

Exclusion criteria: 1. Clinical evidence of shock, as determined by the treating clinician, or requirement for resuscitation (including but not limited to systolic BP< 90 mmHg). 2. Known allergy to TXA 3. Lacking capacity 4. Unwilling to give consent 5. No telephone or unwilling to be contacted by telephone 6. Known paranasal, nasopharyngeal or nasal cavity malignancy 7. Pregnancy 8. Sent to ED for specialist ENT treatment 9. Already undergone pre-hospital nasal packing 10. Prior participation in the study (i.e. received allocated treatment) 11. Prisoners 12. Epistaxis caused by trauma (excluding simple nose picking) 13. Known haemophilia

Design outcomes

Secondary

MeasureTime frame
The following outcomes will be obtained from the ED records, hospital records and at the 7 day follow-up phone call to the participant: 1. Hospital admission 2. Need for blood transfusion 3. Any further treatment for epistaxis during the index ED attendance 4. Recurrent epistaxis requiring hospital treatment, following trial intervention and within 7 days of the index ED attendance 5. Any thrombotic event requiring any hospital re-attendance within 7 days of the index ED attendance 6. Any further hospital treatments required for epistaxis within 7 days of the index ED attendance, including details of the type of hospital episode 7. Number and nature of any adverse events

Primary

MeasureTime frame
Use of anterior nasal packing (of any type) for treatment of epistaxis at any time during the ED attendance, as obtained from ED notes.

Countries

England, Scotland, United Kingdom

Contacts

Public ContactWendy Ingram
wendy.ingram@plymouth.ac.uk+44 1752 315252

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026