Submission date
30/09/2004
Registration date
30/09/2004
Last edited
20/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Mr Dominic Martin-Hirsch

ORCID ID

Contact details

Surgery and Anaesthetics
Calderdale and Huddersfield NHS Trust
Calderdale Royal Hospital
Salterhebble
Halifax
HX3 0PW
United Kingdom
-
abc@email.com

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N0083126301

Study information

Scientific title

A Pilot comparative study of the efficacy and patient acceptability of the Rapid Rhino tamponade balloon and Merocel nasal tampon in acute epistaxis

Acronym

Study hypothesis

There is no difference between the rapid rhino tamponade balloon and the merocel nasal tampon in preventing bleeding from the nose.

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Treatment

Patient information sheet

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

Condition

Signs and Symptoms: Acute epistaxis

Intervention

Rapid rhino tamponade balloon vs merocel nasal tampon

Intervention type

Device

Pharmaceutical study type(s)

Phase

Drug/device/biological/vaccine name(s)

Primary outcome measure

1. Time to cessation of bleeding
2. Patient comfort

Secondary outcome measures

Not provided at time of registration

Overall study start date

13/03/2003

Overall study end date

12/09/2003

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

126 patients

Participant type(s)

Patient

Age group

Not Specified

Sex

Not Specified

Target number of participants

126

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

13/03/2003

Recruitment end date

12/09/2003

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

Calderdale and Huddersfield NHS Trust
Halifax
HX3 0PW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Calderdale and Huddersfield NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes