Condition category
Haematological Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/01/2009
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

Dr Geoffrey P Summerfield

ORCID ID

Contact details

Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
+44 (0)191 482 0000
geoffrey.summerfield@ghnt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0009094224

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

31/08/2000

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20 patients from three centres (2 - 4 from QEH)

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/08/2000

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gateshead Health NHS Trust
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Gateshead Health NHS Trust (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

Results presented in abstract in the BJH under the proceedings of the British Society of Haematology Annual Scientific Meeting in 2005:
BJHaem, 2005, vol 129, (suppl. 1), page 1. Wallis JP, Wells AW, Babb RG, Stainsby D, Hamilton PJ. Effect of storage age of transfused blood on 48hr hb increment and recovery of 2,3 DPG in haematology patients.

Publication citations

Additional files

Editorial Notes