Condition category
Haematological Disorders
Date applied
07/02/2008
Date assigned
26/03/2008
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 A maximum of 16 transfusions will be evaluated per patient before they are withdrawn from the trial.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 measures

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

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

http://www.blood.co.uk

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes