A randomised trial using Zero-Balanced Ultrafiltration in Cardiopulmonary bypass
| ISRCTN | ISRCTN42496709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42496709 |
| Protocol serial number | N0123138588 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr D Machin
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised trial using Zero-Balanced Ultrafiltration in Cardiopulmonary bypass |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular surgery |
| Intervention | Clinical Study|Human Physiology|Inpatient Admission|Multicentre Study: National|NHS Patients|Study of Non-Therapeutic Procedure |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
To establish the effects of Zero-balanced Ultrafiltration with patients in cardiopulmonary bypass |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Key inclusion criteria | 1. Less than 75 years of age 2. Left ventricular function less than 50% 3. Pre-operative haematocrit greater than 30%. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/04/2018: No publications found, study status unverified.
04/03/2016: No publications found, verifying study status with principal investigator.
