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
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