Contact information
Type
Scientific
Primary contact
Mr D Machin
ORCID ID
Contact details
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123138588
Study information
Scientific title
A randomised trial using Zero-Balanced Ultrafiltration in Cardiopulmonary bypass
Acronym
Study hypothesis
To show whether a modified method of ultrafiltration, known as Zero-balance ultrafiltration (ZBUF) is effective in reducing free-radical production during cardiac surgery in adults. A reduction in free radical generation will help protect cell membranes
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
Condition
Cardiovascular surgery
Intervention
Clinical Study|Human Physiology|Inpatient Admission|Multicentre Study: National|NHS Patients|Study of Non-Therapeutic Procedure
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To establish the effects of Zero-balanced Ultrafiltration with patients in cardiopulmonary bypass
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2003
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Less than 75 years of age
2. Left ventricular function less than 50%
3. Pre-operative haematocrit greater than 30%.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/08/2003
Recruitment end date
01/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals of Leicester 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