Platelet Process Improvement Project

ISRCTN	ISRCTN49080246
DOI	https://doi.org/10.1186/ISRCTN49080246
Protocol serial number	CS06/2
Sponsor	National Blood Service (UK)
Funder	National Health Service Blood and Transplant (NHSBT) (UK)

Submission date: 07/02/2008
Registration date: 26/03/2008
Last edited: 20/05/2014

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

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=122

Contact information

Dr Sheila MacLennan
Scientific

Leeds Blood Centre
Bridle Path
Leeds
LS15 7TW
United Kingdom

Phone	+44 (0)7711 447412
Email	sheila.maclennan@nbs.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised, block, non-inferiority, matched pairs, cross-over design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PPIP
Study objectives	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(s)	Leeds (East) Research Ethics Committee on 18/05/2007 (ref: 07/Q1206/50)
Health condition(s) or problem(s) studied	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 A maximum of 16 transfusions will be evaluated per patient before they are withdrawn from the trial.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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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.
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leeds Blood Centre

Leeds
LS15 7TW
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?
Results article	results	01/08/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes