Does routine peri-operative continuous cell salvage in cardiac surgery reduce exposure to allogeneic blood? A randomised controlled trial
| ISRCTN | ISRCTN17615029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17615029 |
| Protocol serial number | PO1003 |
| Sponsor | Papworth Hospital NHS Trust (UK) |
| Funder | Devices and consumables are being provided free of charge by Fresenius Hemocare (UK). No other source of funding secured to date. |
- Submission date
- 20/04/2005
- Registration date
- 24/05/2005
- Last edited
- 22/10/2008
- 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
Dr Andrew Klein
Scientific
Scientific
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Widespread use of new cell salvage technology will reduce the numbers of patients receiving red cells as well as the total units used. |
| Ethics approval(s) | Ethics approval received from Peterborough and Fenland Local Research Ethics Committee on the 22nd April 2005. |
| Health condition(s) or problem(s) studied | Blood transfusion following cardiac surgery |
| Intervention | Patients will be randomised to either the cell saver or control group. A Continuous Auto-Transfusion System (CATS, Fresenius Hemocare) cell saver will be used intra- and post-operatively with the aim of using all processed blood prior to the use of donor blood. Patients in the control group will be managed according to the Papworth hospital protocol. Please note that as of 06/11/2007 the anticipated end date of this trial was changed from 31st December 2007 to 21st May 2007. This trial has now finished recruiting. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The proportion of patients exposed to allogeneic blood. All outcomes measured at 30 days post surgery. |
| Key secondary outcome measure(s) |
1. The number of units of allogeneic red blood cells transfused during first-time cardiac surgery |
| Completion date | 21/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 206 |
| Key inclusion criteria | Patients for non-emergency first-time Coronary Artery Bypass Grafting (CABG) with planned use of cardiopulmonary bypass, and patients for valve repair or replacement, or combined CABG and valve procedure. |
| Key exclusion criteria | 1. Refusal to receive blood or blood products 2. Previous cardiac or thoracic surgery 3. Having an unacceptable risk, as per investigator judgement 4. Known serious coagulation disorders 5. Known blood disorder (thalassemia, chronic anaemia, lymphoproliferative disorder etc.) 6. Any contra-indication to antifibrinolytics 7. The receipt of any investigational drug or participation in a device trial during the course of this trial 8. Where a specific request for cell salvage has been made by the surgeon |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 21/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Papworth Hospital NHS Trust
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
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 | 01/11/2008 | Yes | No |
