Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234135785
Study information
Scientific title
Acronym
Study hypothesis
What component of autologous salvaged blood reverses the immunosuppression resulting from surgery and blood loss?
Ethics approval
No ethics information 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
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Autologous salvage transfusion
Intervention
Randomised into three groups according to the type of postoperative autogous salvage transfusion.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
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 trial start date
01/04/2004
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2004
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Transplantation Sciences
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
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
Basic results (scientific)
Publication list
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15051282
Publication citations
-
Results
Gharehbaghian A, Haque KM, Truman C, Evans R, Morse R, Newman J, Bannister G, Rogers C, Bradley BA, Effect of autologous salvaged blood on postoperative natural killer cell precursor frequency., Lancet, 2004, 363, 9414, 1025-1030, doi: 10.1016/S0140-6736(04)15837-6.