Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/04/2011
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

Miss Christine Swindell

ORCID ID

Contact details

Birmingham Children's Hospital
Main Theatre
Steelhouse Lane
Birmingham
Birmingham
B4 6NH
United Kingdom

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 measures

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

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

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

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17291775

Publication citations

  1. 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.

Additional files

Editorial Notes