Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
18/08/2015
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

Mr Moninder Bhabra

ORCID ID

Contact details

Cardiothoracic Unit
3rd floor
UHCW NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0295142271

Study information

Scientific title

Not provided at time of registration.

Acronym

Study hypothesis

To compare outcomes in patients undergoing coronary artery bypass grafting using either standard non-coated cardiopulmonary circuits or circuits in which all components have been coated with PMEA.

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

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

Condition

Surgery: Cardiopulmonary bypass

Intervention

Prospective randomised controlled trial

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Post-operative blood loss and transfusion requirements, pulmonary, renal, neurological, cardiac and infective complications during hospitalisation, duration of ICU and hospital stay and thirty day mortality. The magnitude of the inflammatory response will be assessed by measuring plasma levels of inflammatory mediators. Platelet function and coagulation will be assessed by flow cytometry and thromboelastography.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/04/2004

Overall trial end date

30/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing first-time, isolated, elective coronary artery bypass grafting at UHCW, who have not taken any anti-platelet medication for five days previous to the operation, will be eligible for the study. We aim to recruit 40 patients.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

1. Patients undergoing repeated surgery
2. Patients undergoing emergency surgery
3. Patients taking antiplatelet medication

Recruitment start date

19/04/2004

Recruitment end date

30/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Unit, 3rd floor
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals Coventry and Warwickshire NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes