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 |
| Protocol serial number | N0045158194 |
| Sponsor | Department of Health |
| Funders | Birmingham Children's Hospital NHS Trust (UK), NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Serum lactate and potassium levels. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2007 | Yes | No |
