The effect of red cell washing on serum biochemistry in neonates and infants undergoing surgery for complex congenital heart disease with cardiopulmonary bypass
| ISRCTN | ISRCTN54081245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54081245 |
| Secondary identifying numbers | N0045158194 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Christine Swindell
Scientific
Scientific
Birmingham Children's Hospital
Main Theatre
Steelhouse Lane
Birmingham
Birmingham
B4 6NH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To determine whether pre-washing red cells affects the serum potassium and lactate levels in young children (<1 year old) who require an irradiated red cell transfusion as part of their open heart surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Congenital heart disease |
| Intervention | A prospective, open label study with each patient randomly assigned to a group. One group will receive unwashed irradiated red cells and the other will receive washed irradiated red cells in the cardiopulmonary bypass circuit prime. |
| Intervention type | Other |
| Primary outcome measure | Serum lactate and potassium levels. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2004 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Children <1 year of age with complex congenital heart defects limited to those undergoing elective or urgent cardiac surgery with cardiopulmonary bypass. |
| Key exclusion criteria | Children undergoing emergency surgery as it will not be possible to pre-wash the irradiated red cells. |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Birmingham Children's Hospital NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
