Plain English Summary
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=122
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sheila MacLennan
ORCID ID
Contact details
Leeds Blood Centre
Bridle Path
Leeds
LS15 7TW
United Kingdom
+44 (0)7711 447412
sheila.maclennan@nbs.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CS06/2
Study information
Scientific title
Comparison of platelets stored for 2 - 5 versus 6 - 7 days in preventing and treating haemorrhage in thrombocytopenic patients: a randomised controlled trial
Acronym
PPIP
Study hypothesis
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.
Ethics approval
Leeds (East) Research Ethics Committee on 18/05/2007 (ref: 07/Q1206/50)
Study design
Randomised, block, non-inferiority, matched pairs, cross-over design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Thrombocytopenia, haemorrhage
Intervention
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 A maximum of 16 transfusions will be evaluated per patient before they are withdrawn from the trial.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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/09/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
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
Recruitment start date
01/09/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Blood Centre
Leeds
LS15 7TW
United Kingdom
Sponsor information
Organisation
National Blood Service (UK)
Sponsor details
c/o Professor Marion Scott
National Blood Service
Southmead Road
Bristol
BS10 5ND
United Kingdom
+44 (0)1179 912000
marion.scott@nbs.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Health Service Blood and Transplant (NHSBT) (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
Basic results (scientific)
Publication list
2013 results in:
MacLennan S, Harding K, Llewelyn C, Choo L, Bakrania L, Massey E, Williamson LM. Comparison of platelets stored for 2-5 days vs 6-7 days in preventing and treating haemorrhage in thrombocytopenic patients a randomised controlled trial. Vox Sang 2013, 105 (Suppl 1), 3C-S21-04, p42.