Platelet Responsiveness and Outcome from Platelet Transfusion (PROmPT)

ISRCTN	ISRCTN56366401
DOI	https://doi.org/10.1186/ISRCTN56366401
Secondary identifying numbers	11139

Submission date: 19/11/2012
Registration date: 19/11/2012
Last edited: 22/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-differences-in-platelets-and-how-well-they-work-prompt

Contact information

Dr Lorna Williamson
Scientific

NHS Blood and Transplant (NHSBT)
Department of Haematology
National Blood Service Centre
Long Road
Cambridge
CB2 2PT
United Kingdom

Email	lorna.williamson@nhsbt.nhs.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Platelet Responsiveness and Outcome from Platelet Transfusion - does inherent variation in donor platelet function affect the clinical efficacy of apheresis platelets? A randomised double blind single centre trial.
Study acronym	PROmPT
Study objectives	The PROMPT study is a randomised double blind controlled trial. We want to determine whether the activity/responsiveness of platelets (as defined by in vitro responsiveness to agonists) given to stable patients with thrombocytopenia (low platelet numbers), affects patients platelet counts following transfusion. We are also interested in investigating whether there is any change in the patients bleeding in the days after the platelet transfusion has been given. We will do this by randomising patients to receive a single platelet transfusion of either high or low responsiveness and monitoring the outcomes. We will also collect some non-randomised ( but still blinded) data on trial units. In addition we will collect the outcome data from some enrolled patients who are given a non-study transfusion of platelets so that we can compare the results to the study transfusions. Platelets are vitally important cells for blood clotting and, as with many human characteristics (such as height, weight etc), there is a normal range of their functional activity as demonstrated by their responsiveness to agonists. Agonists are biological molecules which switch on platelets. This means that the majority of the population have platelets of medium responsiveness; however there is a small percentage of normal individuals who have very active (high responsiveness) or very inactive (low responsiveness) platelets. It is not fully understood what effect differences in platelet activity levels would have for a patient when they are given a platelet transfusion. It is possible that following transfusion very active platelets are more rapidly removed from the circulation. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=11139
Ethics approval(s)	Hertfordshire Research Ethics Committee, 20 July 2011 ref: 11/EE/0227
Health condition(s) or problem(s) studied	National Cancer Research Network, Blood
Intervention	Patients will be randomised to a single unit from either a low or high responding donor. The responsiveness of the donor's platelets in vitro to agonists ( molecules which "switch on" platelets) has been previously determined and has been shown to be reproducible. In addition up to 30 patients will also be monitored for a non-trial (control) transfusion to determine usual outcome for this patient group. Duration of follow-up is 5 days or until the next platelet transfusion (whichever is sooner).
Intervention type	Other
Primary outcome measure	Count increment at 1 hour; measured as difference between pre and 1 hour post transfusion count. Corrected for dose and BSA.
Secondary outcome measures	1. 24 hour count increment measured as difference between pre and 24 hour count 2. Bleeding Score - both patient and clinician assessed 3. Red cell transfusion measured as number of red cell units transfused 4. Time to next platelet transfusion measured as number of days to next transfusion
Overall study start date	03/10/2011
Completion date	03/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	UK Sample Size: 130; Description: 100 Trial units and 30 control units.
Key inclusion criteria	1. Age 16 years or older 2. Stable Haematology/Oncology Patients at Addenbrookes Hospital 3. Thrombocytopenia secondary to bone marrow failure, requiring platelet transfusions according to local and British Committee for Standards in Haematology (BCSH) Guidelines 4. Patients who, if peripheral venous access for blood sampling is required, have adequate access and will consent to their blood being taken in this way 5. Patients able to give written informed consent 6. Male or female
Key exclusion criteria	1. Inherited or acquired clotting disorders 2. Inherited or acquired platelet function disorders 3. Current Acute Promyelocytic Leukaemia 4. Previously documented WHO Grade 4 bleeding (debilitating blood loss) 5. Palpable Splenomegaly 6. Immunological refractoriness to platelet transfusion 7. Require HLA or HPA matched platelets 8. Pregnant or lactating women 9. Other active malignancy in past 5 years
Date of first enrolment	03/10/2011
Date of final enrolment	03/10/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

NHS Blood and Transplant (NHSBT)

Cambridge
CB2 2PT
United Kingdom

Sponsor information

NHS Blood and Transplant [NHSBT] (UK)
Hospital/treatment centre

Research & Development
National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
England
United Kingdom

Website	http://www.nhsbt.nhs.uk/
"ROR"	https://ror.org/0227qpa16

Funders

Funder type

Hospital/treatment centre

NHS Blood and Transplant [NHSBT] (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

22/06/2016: No publications found, verifying study status with principal investigator