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 |
| Secondary identifying numbers | PO1003 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study hypothesis | 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. |
| Condition | 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 | The proportion of patients exposed to allogeneic blood. All outcomes measured at 30 days post surgery. |
| Secondary outcome measures | 1. The number of units of allogeneic red blood cells transfused during first-time cardiac surgery 2. The use of blood products such as fresh frozen plasma and platelet concentrates 3. Adverse events 4. Resource use and cost savings of using CATS in this specific group of patients All outcomes measured at 30 days post surgery. |
| Overall study start date | 01/05/2005 |
| Overall study end date | 21/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 206 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 01/05/2005 |
| Recruitment end date | 21/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Papworth Hospital NHS Trust
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Sponsor information
Papworth Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom
"ROR" |
https://ror.org/01qbebb31 |
|---|
Funders
Funder type
Industry
Devices and consumables are being provided free of charge by Fresenius Hemocare (UK). No other source of funding secured to date.
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 | 01/11/2008 | Yes | No |
