Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0045158194
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Serum lactate and potassium levels.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2004
Overall trial end date
31/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children <1 year of age with complex congenital heart defects limited to those undergoing elective or urgent cardiac surgery with cardiopulmonary bypass.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
40
Participant exclusion criteria
Children undergoing emergency surgery as it will not be possible to pre-wash the irradiated red cells.
Recruitment start date
01/11/2004
Recruitment end date
31/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Children's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17291775
Publication citations
-
Results
Swindell CG, Barker TA, McGuirk SP, Jones TJ, Barron DJ, Brawn WJ, Horsburgh A, Willetts RG, Washing of irradiated red blood cells prevents hyperkalaemia during cardiopulmonary bypass in neonates and infants undergoing surgery for complex congenital heart disease., Eur J Cardiothorac Surg, 2007, 31, 4, 659-664, doi: 10.1016/j.ejcts.2007.01.014.