The clinical effect of length of pre-transfusion storage of blood
| ISRCTN | ISRCTN06273643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06273643 |
| Protocol serial number | N0009094224 |
| Sponsor | Department of Health (UK) |
| Funder | Gateshead Health NHS Trust (UK) |
- 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
Scientific
Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
| Phone | +44 (0)191 482 0000 |
|---|---|
| geoffrey.summerfield@ghnt.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
48-hour post transfusion haemoglobin (Hb) increment. |
| Key secondary outcome measure(s) |
1. Changes in red cell 2,3-DPG concentration and Hb-oxygen affinity (P50) |
| Completion date | 31/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| 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
- United Kingdom
- England
Study participating centre
Gateshead Health NHS Trust
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
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? |
|---|---|---|---|---|---|
| Abstract results | abstract page 1 | 01/04/2005 | No | No |
