The clinical effect of length of pre-transfusion storage of blood

ISRCTN	ISRCTN06273643
DOI	https://doi.org/10.1186/ISRCTN06273643
Secondary identifying numbers	N0009094224

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 22/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Geoffrey P Summerfield
Scientific

Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Phone	+44 (0)191 482 0000
Email	geoffrey.summerfield@ghnt.nhs.uk

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	That the management of patients requiring regular blood transfusions for anaemia may be enhanced by using fresh blood rather than blood stored for prolonged periods. This may improve patients' quality of life, reduce the risks of infection and iron overload and conserve scare blood resources.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anaemia
Intervention	Stable patients requiring blood transfusions for anaemia more often than every 6 weeks will be recruited. They will be randomised to receive two transfusions of four units of "fresh" blood (less than 10 days old) or two transfusions of "old" blood (24-35 days old). There will then be a crossover in which patients receive two further transfusions of four units of the opposite type of blood. The following will be measured pre-transfusion and at completion of transfusion, 48 h post-transfusion and 14 days after transfusion: Full blood count (FBC), retics, 2,3-diphosphoglycerate (2-3-DPG), P50, haptoglobin. Pre-transfusion, serum ferritin will also be measured and QOL assessed. QOL assessment will be repeated at 14 days post transfusion.
Intervention type	Other
Primary outcome measure	48-hour post transfusion haemoglobin (Hb) increment.
Secondary outcome measures	1. Changes in red cell 2,3-DPG concentration and Hb-oxygen affinity (P50) 2. Subsequent changes in Hb at 14 days and before next transfusion 3. Changes in patients' quality of life (QOL) as measured by SF-36 health survey and a visual analogue scale
Overall study start date	31/08/2000
Completion date	31/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	20 patients from three centres (2 - 4 from QEH)
Key inclusion criteria	1. Patients 18 and over with a haematological disorder requiring regular red cell transfusion (eg myelodysplastic syndrome, aplastic anaemia, etc) 2. Able to give informed consent 3. Serum creatinine <200 umol/l within past 2 months
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/08/2000
Date of final enrolment	31/08/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Gateshead Health NHS Trust

Gateshead
NE9 6SX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Gateshead Health NHS Trust (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?
Abstract results	abstract page 1	01/04/2005		No	No