Condition category
Circulatory System
Date applied
10/04/2017
Date assigned
01/06/2017
Last edited
06/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Nosebleeds are a very common condition. In most cases nosebleeds stop with simple first aid measures, but some cases are more serious, leading to hospital admission or even death. Patients with serious nosebleed attending the emergency department (ED) are initially treated with vasoconstrictors (applying a solution to the inside of the nostril that causes blood vessels to contract) or cauterisation (briefly burning the blood vessel to seal it). If bleeding cannot be stopped with these measures, patients usually undergo nasal packing. Nasal packing involves stuffing the nasal passage tightly with a dressing to apply pressure to the source of the bleeding, which can be an extremely uncomfortable and painful experience. The nasal pack is left in place for about 48 hours and patients are kept in hospital for monitoring during this time. In other conditions where bleeding is a problem, tranexamic acid (TXA) has been shown to help the normal blood clotting process, making clots less likely to break down. TXA has the potential to safely stop serious nosebleeds, and reduce the need for patients to undergo nasal packing and an in-patient hospital stay. The aim of this study is to evaluate the effectiveness of TXA in the treatment of serious nosebleeds.

Who can participate?
Patients with a serious nosebleed that fails to stop after first aid and initial treatment in the emergency department.

What does the study involve?
Participants agree to take part while having simple, empergency treatment to for their nosebleed which usually, at least temporarily, controls bleeding. In their nose continues to bleed after the initial treatment, participants continue in the study. These participants are randomly allocated into one of two groups. For those in the first group, a cotton wool roll soaked in TXA is gently inserted into the bleeding nostril and held in place with a nose-clip for about 10 minutes. This can be repeated once more if the bleeding continues. Those in the second group receive the same treatment except the cotton wool roll is soaked in water. Participants in both groups then go on to receive usual care. One week later, participants are contacted by telephone in order to find out about recovery, and medical notes are reviewed.

What are the possible benefits and risks of participating?
TXA may help to stop nose bleeds, so those allocated to receive TXA treatment may benefit from having their nose bleed stop without need for further hospital treatment. There are no notable risks involved with participating.

Where is the study run from?
Royal Devon & Exeter Hospital (lead centre) and 13 other NHS hospitals in England and Scotland (UK)

When is the study starting and how long is it expected to run for?
August 2016 to January 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Wendy Ingram
wendy.ingram@plymouth.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Wendy Ingram

ORCID ID

Contact details

Peninsula Clinical Trials Unit
N16
ITTC Building 1
Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
+44 1752 315252
wendy.ingram@plymouth.ac.uk

Additional identifiers

EudraCT number

2016-001530-10

ClinicalTrials.gov number

Protocol/serial number

33607

Study information

Scientific title

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

Acronym

NoPac

Study hypothesis

The aim of this study is to investigate the safety and efficacy of TXA in stopping serious nosebleeds, reducing the need for patients to undergo nasal packing and an in-patient hospital stay.

Ethics approval

South West - Central Bristol Research Ethics Committee, 03/02/2017, ref: 17/SW/0010

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Injuries and emergencies, Primary sub-specialty: Pre-hospital and Emergency Department Care; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the head

Intervention

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. Randomisation will be achieved by means of selection of the next available treatment pack, obtained from a designated, locked cupboard (or other suitable secure location) within the ED at each site. Randomisation packs will be prepared and supplied in advance to participating hospital pharmacy departments by Stockport Pharmaceuticals. Packs will be labelled with a unique number generated by Stockport Pharmaceuticals in conjunction with an independent statistician, using random permuted blocks of variable size to achieve treatment allocation in a 1:1 ratio. Randomisation will be stratified by site. Participants and research staff are blinded to treatment allocation. The trial treatment and comparator will be presented identically.

Intervention group: Participants receive TXA intra-nasally (topically).The dose of TXA is 2ml (200mg) soaked on a dental roll and inserted into the bleeding nostril for 10 minutes. If this does not control the bleeding, then a second dose of 2ml will be given over 10 minutes (400 mg in total). The trial treatment will be prescribed by a clinician who has been approved to undertake this task on the study delegation log.

Control group: Participants receive a placebo intra-nasally (topically). The placebo is 2ml water for injection (for topical use).

In both groups, the treatment will be given in the Emergency Department (ED) during the ED attendance only. No further treatment will be given after discharge or transfer from the ED. The duration of treatment is likely to be around 30 minutes in total (10 mins per dose, plus time to reassess in between doses).

The research nurse will complete data collection up to the time of discharge or transfer from the ED. She will complete follow-up data collection by examination of the participant’s ED and hospital records up to one week from the ED admission. One follow-up phone call will be made to the participant 7 days after admission to collect adverse event and outcome data. There will be no further follow-up after one week.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/08/2016

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 450; UK Sample Size: 450

Participant 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

Recruitment start date

05/05/2017

Recruitment end date

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Derriford Hospital
Derriford Road
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Gloucester Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Trial participating centre

Cheltenham General Hospital
College Road
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

North Devon District Hospital
Raleigh Park
Barnstaple
EX31 4JB
United Kingdom

Trial participating centre

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Royal Derby Hospital
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

Royal Cornwall Hospital
2 Penventinnie Lane Treliske
Truro
TR1 3LQ
United Kingdom

Sponsor information

Organisation

Royal Devon and Exeter NHS Foundation Trust

Sponsor details

Royal Devon & Exeter Hospital
Barrack Road
Exeter
EX2 5DW
United Kingdom
+44 1392 403017
Christopher.gardner@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol will be published in an open access clinical journal approximately one year after the recruitment start date. On completion of analyses, a final study report will be prepared for the funder. End of study reports will also be sent to REC and MHRA within 12 months of the end of the study.
The study results will be submitted for publication in international, high impact, peer reviewed journals primarily relating to emergency medicine but also to ENT and primary care specialties. The CI will draw up a publication policy for the study to outline publication plans and specify how authorship on publications will be determined. Drafts of all papers intended for publication will be sent to the funding body (NIHR RfPB) for review prior to publication and the funding body will be acknowledged within all publications. Members of the TMG, TSC and DMC will also have prior access to the unblinded trial results and embargoed press release(s), subject to suitable confidentiality arrangements. The study findings will be presented at regional, national and international meetings as appropriate.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/01/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.