Identifying a blood test to predict risk of deterioration of brain haemorrhage
| ISRCTN | ISRCTN90048218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90048218 |
| Secondary identifying numbers | V1; 9/2/15 |
- Submission date
- 04/02/2015
- Registration date
- 13/02/2015
- Last edited
- 04/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is a serious, life-threatening medical condition that usually happens when a blood clot or haemorrhage cuts of the blood supply to an area of the brain. One in 5 strokes, is caused by a haemorrhage (intracerebral haemorrhage (ICH)) . A high number of patients who have a ICH die within the first few hours and more than half of those who do survive are left with a long term disability. In around a third of cases the brain tissue becomes swollen and inflamed around the blood clot (haematoma)in the hours after the initial bleed into the brain. This is known as haematoma expansion and means it has grown in size. As the space within the skull is already tight, any swelling puts huge pressure of the brain itself, squashing it and causing brain damage. A patient who initially appeared to be quite well can suddenly deteriorate and lose consciousness, often requiring emergency surgery to relieve the pressure within the brain. Finding a treatment to prevent haematoma expansion has proven difficult as by the time the symptoms present, it may be too late to show any real benefit. Whilst it is important to establish which patients are most at risk of haematoma expansion, current tests using signs on brain imaging have proved less than reliable, so this remains a target for researchers. The aim of this study is to identify a blood test that will detect novel biomarkers (which can be defined as “medical signs” that can help predict a disease or outcome of a disease) that predict early haematoma expansion after intracerebral haemorrhage.
Who can participate?
Adults that have had a ICH, are likely to survive beyond the next 24 hours and from which a blood sample can be taken within 3 hours of the ICH.
What does the study involve?
Blood samples are taken from each participant within 3 hours of onset of symptoms of intracerebral haemorrhage for proteomic (protein) analysis of novel biomarkers. They also have a CT scan (brain imaging) 24-36 hours after their ICH to look for signs of a haematoma expansion. Plasma biomarkers of patients with and without haematoma expansion are compared.
What are the possible benefits and risks of participating?
There are no benefits to study participation as this is an observational study. Risks are associated with blood sampling (bruising) and exposure to radiation when undergoing CT scan (equivalent to half the yearly background radiation).
Where is the study run from?
Salford Royal NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2015 to December 2018
Who is funding the study?
Salford Royal NHS Foundation Trust Hyperacute Research fund (UK)
Who is the main contact?
Dr Adrian Parry-Jones
adrian.parry-jones@manchester.ac.uk
Contact information
Scientific
Vascular and Stroke Centre
Institute of Cardiovascular Sciences
University of Manchester
Salford Royal NHS Foundation Trust
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
United Kingdom
| Phone | 0161 206 4458 |
|---|---|
| adrian.parry-jones@manchester.ac.uk |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Identification of novel biomarkers to predict early haematoma expansion after intracerebral haemorrhage |
| Study acronym | PRIME-ICH |
| Study objectives | The aim of this study is to identify a blood test that will detect novel biomarkers that predict early haematoma expansion after intracerebral haemorrhage. |
| Ethics approval(s) | North West - Haydock Research Ethics Committee, 28/05/2016, ref: 15/NW/0387 |
| Health condition(s) or problem(s) studied | Intracerebral haemorrhage (haemorrhagic stroke) |
| Intervention | Blood sampling within 3 hours of onset of symptoms of intracerebral haemorrhage for proteomic analysis of novel biomarkers. Research brain imaging (CT scan) at 24-36 hour from symptoms onset for signs of haematoma expansion. Plasma biomarkers of patients with and without haematoma expansion will be compared. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Identification of novel biomarkers for risk of early haematoma expansion after ICH and identification of a proteomic profile of plasma in hyperacute ICH patients who progress to haematoma expansion. This will be measured by analysis inflammatory biomarkers and proteomic profile of the baseline blood sample (taken within 3 hours of symptom onset). |
| Secondary outcome measures | N/A |
| Overall study start date | 01/04/2015 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Diagnosis of primary ICH confirmed by CT brain scan 2. Ability to collect research blood sample within 3 h of symptom onset 3. Likely to survive beyond 24 h (e.g. GCS > 5) 4. ICH not felt to be secondary to an underling structural abnormality (vascular malformation, aneurysm, tumour) or trauma. |
| Key exclusion criteria | 1. Under 18 2. End of life (not expected to survive passed 24 h 3. Other concomitant condition 4. Participation in a CTIMP 5. Pregnancy |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Salford
M6 8HD
United Kingdom
Sponsor information
University/education
Room 3.53 Simon Building
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | 0161 275 8795 |
|---|---|
| fmhsethics@manchester.ac.uk | |
| Website | FMHS Research Governance Website |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/09/2017: Recruitment end date has been updated from 30/09/2016 to 31/12/2017. The overall trial end date has been updated from 30/09/2016 to 31/12/2018.
24/03/2016: Ethics approval information added.
