Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof B A Bradley

ORCID ID

Contact details

Department of Transplantation Sciences
North Bristol NHS Trust
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)117 959 5340

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234135785

Study information

Scientific title

Acronym

Study hypothesis

What component of autologous salvaged blood reverses the immunosuppression resulting from surgery and blood loss?

Ethics approval

No ethics information 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

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgery: Autologous salvage transfusion

Intervention

Randomised into three groups according to the type of postoperative autogous salvage transfusion.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

In vitro measures of immune status including changes in cytokine profiles and populations of certain lymphocyte subsets in whole blood.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2004

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

60 patients undergoing total knee arthroplasty at Avon Orthopaedic Centre randomised into three groups according to type of post-operative autologous salvage transfusion.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2004

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Transplantation Sciences
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

North Bristol 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

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15051282

Publication citations

  1. Results

    Gharehbaghian A, Haque KM, Truman C, Evans R, Morse R, Newman J, Bannister G, Rogers C, Bradley BA, Effect of autologous salvaged blood on postoperative natural killer cell precursor frequency., Lancet, 2004, 363, 9414, 1025-1030, doi: 10.1016/S0140-6736(04)15837-6.

Additional files

Editorial Notes