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ISRCTN
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ISRCTN49080246
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ClinicalTrials.gov identifier
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Public title
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Platelet Process Improvement Project
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Scientific title
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Comparison of platelets stored for 2 - 5 versus 6 - 7 days in preventing and treating haemorrhage in thrombocytopenic patients: a randomised controlled trial
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Acronym
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PPIP
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Serial number at source
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CS06/2
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Study hypothesis
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To test the null hypothesis that extension of the allowable storage period for platelet components to 7 days from the current standard of 5 days does not lead to any clinically significant reduction in their efficacy for preventing and treating bleeding in patients whose platelet count is low. Both platelets suspended in plasma and platelets suspended in an additive solution/plasma mixture will be studied.
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Ethics approval
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Ethics approval received from the Leeds (East) Research Ethics Committee on the 18th May 2007 (ref: 07/Q1206/50)
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Study design
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Randomised, block, non-inferiority, matched pairs, cross-over design
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Thrombocytopenia, haemorrhage
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Participants - inclusion criteria
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Adult (aged 16 or above) haemato-oncology patients who are thrombocytopenic because of bone marrow failure in Manchester Royal Infirmary and Bristol Royal Infirmary requiring platelet transfusion according to local and British Committee for Standards in Haematology (BCSH) guidelines.
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Participants - exclusion criteria
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1. Inherited or acquired clotting disorders
2. Inherited or acquired platelet function disorders
3. Acute promyelocytic leukaemia
4. Previously documented World Health Organization (WHO) grade 4 bleeding (debilitating blood loss)
5. Pregnant females
6. Splenomegaly
7. Immunological refractoriness to platelet transfusion
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Anticipated start date
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01/09/2007
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Patients will be randomised to receive a sequence of transfusions in blocks of two, so that within each block there will be one allocation for standard 2 - 5 day old platelets, and one allocation for 6 - 7 day platelets, in random order. A maximum of 16 transfusions will be evaluated per patient before they are withdrawn from the trial. The duration of interventions depends upon the length of each in-patient stay as only transfusions received as an in-patient will provide the researchers with a post transfusion platelet count to enable calculation of a platelet increment.
Participants will be assessed for bleeding daily using a structured assessment form, either by medical or self-assessment. Routine blood tests will allow calculation of an 18 - 24 hour platelet increment following platelet transfusion.
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Primary outcome measure(s)
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The proportion of successful transfusions, of either 2 - 5 or 6 - 7 days, as measured by 18 - 24 hour Corrected Count Increment (CCI), within the first block. Platelet increment is defined as the post -transfusion platelet count minus pre-transfusion platelet count (x 10^9/L). The CCI is calculated from the platelet increment (PI), body surface area (BSA) in metres squared, and dose of platelets (PD) transfused (x 10^11).
CCI = PI x BSA x PD-1
A successful transfusion is defined as a CCI greater than 4.5 x 10^9/L.
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Secondary outcome measure(s)
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1. Proportion of successful transfusions in all blocks
2. Mean 18 - 24 hour CCI following transfusions in the first block only
3. Mean 18 - 24 hour CCI following transfusions in all blocks
4. Proportion of days a patient has a bleeding score WHO grade 2 or more during the first and subsequent intervals between transfusions. Bleeding will be assessed and monitored daily using a structured assessment form. Assignment of bleeding grades to a modification of the WHO bleeding score will be performed by a computerised algorithm.
4. Interval (number of days) to the second and subsequent platelet transfusions
5. Incidence of acute reactions to each platlet transfusion
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Sources of funding
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National Health Service Blood and Transplant (NHSBT) (UK)
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Trial website
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Publications
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Contact name
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Dr
Sheila
MacLennan
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Address
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Leeds Blood Centre
Bridle Path
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City/town
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Leeds
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Zip/Postcode
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LS15 7TW
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Country
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United Kingdom
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Tel
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+44 (0)7711 447412
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Fax
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+44 (0)1132 148696
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Email
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sheila.maclennan@nbs.nhs.uk
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Sponsor
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National Blood Service (UK)
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Address
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c/o Professor Marion Scott
National Blood Service
Southmead Road
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City/town
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Bristol
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Zip/Postcode
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BS10 5ND
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Country
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United Kingdom
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Tel
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+44 (0)1179 912000
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Email
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marion.scott@nbs.nhs.uk
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Sponsor website:
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http://www.blood.co.uk
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Date applied
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07/02/2008
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Last edited
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02/09/2008
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Date ISRCTN assigned
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26/03/2008
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