Fibrin sealant to reduce blood loss after hip replacement

ISRCTN	ISRCTN10862406
DOI	https://doi.org/10.1186/ISRCTN10862406
Secondary identifying numbers	N0234117607

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr DKA Smart
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Fibrin sealant to reduce blood loss after hip replacement
Study objectives	Does fibrin sealant reduce blood loss after primary and revision hip replacement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Hip replacement
Intervention	Two groups: Revision total hip replacement and Primary total hip replacement.
Intervention type	Procedure/Surgery
Primary outcome measure	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 study start date	01/08/2002
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	90
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2002
Date of final enrolment	31/07/2003

North Bristol NHS Trust

Bristol
BS10 5NB
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

North Bristol NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan