Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr DKA Smart

ORCID ID

Contact details

Department of Orthopaedics (AOC)
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234117607

Study information

Scientific title

Fibrin sealant to reduce blood loss after hip replacement

Acronym

Study hypothesis

Does fibrin sealant reduce blood loss after primary and revision hip replacement?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Hip replacement

Intervention

Two groups: Revision total hip replacement and Primary total hip replacement.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Quantitative estimate of per-operative blood loss, measurement of post-operative blood loss volume via drains, post-operative haemaglobin level, number of patients requiring blood transfusion.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Primary hip replacement: 60 patients not on anticoagulant medications, without blood autoantibodies and with pre-operation Hb level >12.5 will be randomised into treatment and control groups.
Revision hip replacement: 30 consecutive patients in treatment group not randomized. Control group will be historical, with information regarding blood loss gained from a retrospective review of notes.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

North Bristol 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes