A prospective randomised controlled trial to determine the nature of the immunostimulants in autologous salvaged blood

ISRCTN	ISRCTN64731819
DOI	https://doi.org/10.1186/ISRCTN64731819
Secondary identifying numbers	N0234135785

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof B A Bradley
Scientific

Department of Transplantation Sciences
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Phone	+44 (0)117 959 5340

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	What component of autologous salvaged blood reverses the immunosuppression resulting from surgery and blood loss?
Ethics approval(s)	No ethics information provided at time of registration.
Health condition(s) or problem(s) studied	Surgery: Autologous salvage transfusion
Intervention	Randomised into three groups according to the type of postoperative autogous salvage transfusion.
Intervention type	Procedure/Surgery
Primary outcome measure	In vitro measures of immune status including changes in cytokine profiles and populations of certain lymphocyte subsets in whole blood.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2004
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	60 patients undergoing total knee arthroplasty at Avon Orthopaedic Centre randomised into three groups according to type of post-operative autologous salvage transfusion.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2004
Date of final enrolment	31/03/2005

Department of Transplantation Sciences

Bristol
BS10 5NB
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Hospital/treatment centre

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/03/2004		Yes	No