Contact information
Type
Scientific
Primary contact
Mr Alex Shipolini
ORCID ID
Contact details
Consultant Cardiothoracic Surgeon
Department of Cardiothoracic Surgery
The London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom
+44 (0)20 8983 2322
alex.shipolini@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205123739
Study information
Scientific title
Post-operative use of cell savers
Acronym
Study hypothesis
To investigate whether the dedeco-electra cell saver reduces homologous transfusion requirements in the post-operative phase and whether in conjunction with leucocyte filtration may reduce inflammation as measured by IL-6, IL8A, IL-10 release a leucocyte activation CD69 and CD11 a (flow cytometry) in the retransfused salvaged blood.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Homologous transfusion
Intervention
Not provided at time of registration
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Reduction in requirement for homologous blood transfusion
2. Reduction in flammatory mediators and activated leucocytes in the washed, salvaged autologous red cells
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/05/2003
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Barts and the London NHS Trust patients
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2003
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The London Chest Hospital
London
E2 9JX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Barts and The London NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary