ISRCTN ISRCTN57101575
DOI https://doi.org/10.1186/ISRCTN57101575
Secondary identifying numbers N0205123739
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
14/06/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Alex Shipolini
Scientific

Consultant Cardiothoracic Surgeon
Department of Cardiothoracic Surgery
The London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom

Phone +44 (0)20 8983 2322
Email alex.shipolini@bartsandthelondon.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePost-operative use of cell savers
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Homologous transfusion
InterventionNot provided at time of registration
Intervention typeProcedure/Surgery
Primary outcome measure1. Reduction in requirement for homologous blood transfusion
2. Reduction in flammatory mediators and activated leucocytes in the washed, salvaged autologous red cells
Secondary outcome measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date01/08/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaBarts and the London NHS Trust patients
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/05/2003
Date of final enrolment01/08/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The London Chest Hospital
London
E2 9JX
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Barts and The London NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

14/06/2017: No publications found in PubMed, verifying study status with principal investigator