Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lorna Williamson
ORCID ID
Contact details
NHS Blood and Transplant (NHSBT)
Department of Haematology
National Blood Service Centre
Long Road
Cambridge
CB2 2PT
United Kingdom
-
lorna.williamson@nhsbt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11139
Study information
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.
Acronym
PROmPT
Study hypothesis
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
Hertfordshire Research Ethics Committee, 20 July 2011 ref: 11/EE/0227
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
03/10/2011
Overall trial end date
03/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 130; Description: 100 Trial units and 30 control units.
Participant 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
Recruitment start date
03/10/2011
Recruitment end date
03/10/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NHS Blood and Transplant (NHSBT)
Cambridge
CB2 2PT
United Kingdom
Sponsor information
Organisation
NHS Blood and Transplant [NHSBT] (UK)
Sponsor details
Research & Development
National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
NHS 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