The low platelet blood study
| ISRCTN | ISRCTN95606674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95606674 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 05/01/2017
- Registration date
- 10/01/2017
- Last edited
- 09/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Haematological Disorders
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
Contact information
Scientific
Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS28ED
United Kingdom
 ORCID ID |
0000-0001-5248-8165 |
|---|---|
| Phone | +44 117 342 1113 |
| c.bradbury@bristol.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | The development of laboratory assays for patients with low platelet counts to help predict treatment responses |
| 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(s) | South East Coast - Brighton and Sussex NRES Committee, 30/11/2015, ref: 15/LO/2088 |
| 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 | |
| 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 study start date | 07/03/2016 |
| Overall study end date | 05/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 100 |
| 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 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
- England
- United Kingdom
Study participating centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Sponsor information
University/education
Tyndall Avenue
Bristol
BS81TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 05/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
