ISRCTN ISRCTN49080246
DOI https://doi.org/10.1186/ISRCTN49080246
Secondary identifying numbers CS06/2
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

Study designRandomised, block, non-inferiority, matched pairs, cross-over design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison of platelets stored for 2 - 5 versus 6 - 7 days in preventing and treating haemorrhage in thrombocytopenic patients: a randomised controlled trial
Study acronymPPIP
Study objectivesTo 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) studiedThrombocytopenia, haemorrhage
InterventionPatients 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 A maximum of 16 transfusions will be evaluated per patient before they are withdrawn from the trial.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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date01/09/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteriaAdult (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 criteria1. 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 enrolment01/09/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds Blood Centre
Leeds
LS15 7TW
United Kingdom

Sponsor information

National Blood Service (UK)
Government

c/o Professor Marion Scott
National Blood Service
Southmead Road
Bristol
BS10 5ND
United Kingdom

Phone +44 (0)1179 912000
Email marion.scott@nbs.nhs.uk
Website http://www.blood.co.uk
ROR logo "ROR" https://ror.org/0227qpa16

Funders

Funder type

Government

National Health Service Blood and Transplant (NHSBT) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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