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 |
| Protocol serial number | N0234135785 |
| Sponsor | Department of Health |
| Funder | North Bristol NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
In vitro measures of immune status including changes in cytokine profiles and populations of certain lymphocyte subsets in whole blood. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Transplantation Sciences
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
