Condition category
Surgery
Date applied
20/04/2005
Date assigned
24/05/2005
Last edited
22/10/2008
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

Dr Andrew Klein

ORCID ID

Contact details

Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PO1003

Study information

Scientific title

Acronym

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

Ethics approval received from Peterborough and Fenland Local Research Ethics Committee on the 22nd April 2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2005

Overall trial end date

21/05/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

206

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

United Kingdom

Trial participating centre

Papworth Hospital NHS Trust
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Trust (UK)

Sponsor details

Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Devices and consumables are being provided free of charge by Fresenius Hemocare (UK). No other source of funding secured to date.

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18931203

Publication citations

  1. Results

    Klein AA, Nashef SA, Sharples L, Bottrill F, Dyer M, Armstrong J, Vuylsteke A, A randomized controlled trial of cell salvage in routine cardiac surgery., Anesth. Analg., 2008, 107, 5, 1487-1495, doi: 10.1213/ane.0b013e3181831e54.

Additional files

Editorial Notes