Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/03/2016
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 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

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

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

Publication citations

Additional files

Editorial Notes

04/03/2016: No publications found, verifying study status with principal investigator.