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 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof B A Bradley
Scientific
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 information
| 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 |
Eligibility
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Transplantation Sciences
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
North Bristol NHS Trust (UK)
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/03/2004 | Yes | No |
