Condition category
Haematological Disorders
Date applied
05/01/2017
Date assigned
10/01/2017
Last edited
09/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Platelets are the component of blood which helps the blood to clot. A low platelet count can cause bleeding and bruising which can sometimes be serious. There are many different causes and treatments depend on the cause. It is not always easy for doctors to diagnose the cause and often many investigations are needed including uncomfortable bone marrow biopsy tests. In addition, even when the cause is known, different treatments may be tried before finding one that works. Some of the treatments used may have side effects and it would be helpful to develop blood tests that would predict which medicines will make which patients better. This would help treatment to be individualised, speeding up the time to get better and avoiding side effects of treatments that don't work. This study aims to develop new laboratory test to help with the diagnosis, identification of how the disease is working and prediction of treatment response in patients with low platelet counts.

Who can participate?
Patients aged 16 years and over who have a low platelet count and are in need of treatment.

What does the study involve?
During routine hospital appointments, patients with low platelet counts are asked if they are happy to provide an extra sample of blood when having routine blood tests. The blood samples are then sent to different laboratory studies so that new tests can be developed to help with the diagnosis, identification of how the disease is working and prediction of treatment response in patients with low platelet counts.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.

Where is the study run from?
Bristol Haematology and Oncology Centre (UK)

When is the study starting and how long is it expected to run for?
January 2015 to March 2018

Who is funding the study?
Above and Beyond (UK)

Who is the main contact?
Dr Charlotte Bradbury
c.bradbury@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Bradbury

ORCID ID

http://orcid.org/0000-0001-5248-8165

Contact details

Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS28ED
United Kingdom
+44 117 342 1113
c.bradbury@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

The development of laboratory assays for patients with low platelet counts to help predict treatment responses

Acronym

Study hypothesis

The aim of this study is to develop new laboratory tests to assist with diagnosis, identification of disease mechanism and prediction of treatment response in patients with low circulating platelet counts.

Ethics approval

South East Coast - Brighton and Sussex NRES Committee, 30/11/2015, ref: 15/LO/2088

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Thrombocytopenia

Intervention

There will be no additional hospital appointments or venepunctures done specifically for this research. During a routine hospital appointment, each participant will be given patient information and the opportunity to ask questions. They will then be asked to given written consent. Following consent, when they are having other bloods done we will take extra blood samples for research (maximum of 50ml). The consent procedure is estimated to take 30 mins and is done by the Consultant in charge of their haematology condition. The samples will be anonymised and sent to different laboratory’s in Bristol for different assays: NHS BT Filton for antibody assays, North Bristol haematology laboratory for lymphocyte subsets, UH Bristol haematology laboratory for platelet counting and ROTEM if done and University of Bristol research laboratory’s for short term lymphocyte culture experiments. DNA may also be stored in a secure -70 freezer on level 8 BRI.

Patients may be asked to give further samples (maximum of 3 times per year).

Patients will receive standard treatments according to their condition and treatment responses (bleeding episodes, platelet count data, side effects) will be anonymised and recorded on a secure database. The results of laboratory assays will be correlated with clinical data over a minimum of 12 months.

Intervention type

Phase

Drug names

Primary outcome measure

Candidate biomarkers of clinical response are assessed by evaluating the correlation of laboratory assay results to clinical response data (bleeding and platelet count data over at least 12 months, the latter will be collected from routine blood tests done on patients according to clinical need).

Secondary outcome measures

Positive and negative predictive value of some assays to specific causes of low platelet count and discrepancy of results from different types of assay used to measure low platelet counts.

Overall trial start date

07/03/2016

Overall trial end date

05/01/2026

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age range >16 years old
2. Male and female
3. Low platelet count AND need for treatment
4. Hb>100g/l

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Hb<100g/L
2. Patients unable to consent (e.g. due to mental incapacity)

Recruitment start date

07/03/2016

Recruitment end date

05/01/2025

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Haematology and Oncology Centre
University Hospital Bristol Horfield Road
Bristol
BS2 8ED
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Tyndall Avenue
Bristol
BS81TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Above and Beyond

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned presentation of the research findings at international meetings and publish them in high-impact peer reviewed journals. It is expected that some interim results be ready within 3 years by 2020. In addition, a plain English summary of the research findings will be published in “the platelet” a monthly magazine from the ITP support association (a patient and public group).

IPD Sharing plan:
This study will generate numerous sets of complex data for different elements of this study. The remit of the study is broad, and aims to generate pilot data to be validated prospectively in future clinical trials. Due to the complexity of the data generated, at present we cannot guarantee we will be able to make available participant level data but we do plan to generate a plain English summary of the main research findings when available. The anonymised data will be stored securely.

Intention to publish date

05/01/2027

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes