Condition category
Circulatory System
Date applied
04/02/2015
Date assigned
13/02/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 September 2016

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adrian Parry-Jones

ORCID ID

Contact details

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
0161 206 4458
adrian.parry-jones@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1; 9/2/15

Study information

Scientific title

Identification of novel biomarkers to predict early haematoma expansion after intracerebral haemorrhage

Acronym

PRIME-ICH

Study hypothesis

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

North West - Haydock Research Ethics Committee, 28/05/2016, ref: 15/NW/0387

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2015

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/05/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Room 3.53 Simon Building
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
0161 275 8795
fmhsethics@manchester.ac.uk

Sponsor type

University/education

Website

FMHS Research Governance Website

Funders

Funder type

Hospital/treatment centre

Funder name

Salford Royal NHS Foundation Trust Hyperacute Research fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.