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ISRCTN
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ISRCTN17615029
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ClinicalTrials.gov identifier
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Public title
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Does routine peri-operative continuous cell salvage in cardiac surgery reduce exposure to allogeneic blood? A randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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PO1003
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Study hypothesis
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Widespread use of new cell salvage technology will reduce the numbers of patients receiving red cells as well as the total units used.
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Lay summary
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Ethics approval
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Ethics approval received from Peterborough and Fenland Local Research Ethics Committee on the 22nd April 2005.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Blood transfusion following cardiac surgery
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2005
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Anticipated end date
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21/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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206
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Interventions
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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.
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Primary outcome measure(s)
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The proportion of patients exposed to allogeneic blood. All outcomes measured at 30 days post surgery.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Devices and consumables are being provided free of charge by Fresenius Hemocare (UK). No other source of funding secured to date.
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18931203
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Contact name
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Dr
Andrew
Klein
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Address
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Papworth Hospital NHS Trust
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Sponsor
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Papworth Hospital NHS Trust (UK)
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Address
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Papworth Hospital
Papworth Everard
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City/town
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Cambridge
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Zip/Postcode
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CB3 8RE
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Country
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United Kingdom
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Date applied
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20/04/2005
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Last edited
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22/10/2008
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Date ISRCTN assigned
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24/05/2005
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