Australia’s unique, ultra-early surgery trial to minimise stroke damage caused by bleeding in the brain
Jenni trained in stroke research after her dad had a stroke caused by bleeding in the brain. She is Associate Investigator and consumer adviser on a trial designed to reduce loss of function in survivors of this kind of stroke.
Bleeding in the brain causes 55% of stroke-related lost life years
A stroke caused by bleeding into the brain is an intracerebral haemorrhage (ICH). ICH causes just 30% of strokes. But ICH damage causes 55% of stroke-related lost life years. ICH also leads to 35% of stroke fatalities in 28 days after the stroke occurs.
Nurse Consultant Jenni Cranefield, Royal Adelaide Hospital, saw her dad struggle to regain functions after his stroke. ‘ICH is one of the few areas in stroke where we haven’t made big jumps in treatment improvement,’ Jenni learned.
Professor Bruce Campbell from Royal Melbourne Hospital and University of Melbourne agrees. ‘ICH is a huge unmet need. We have no effective treatments other than stroke unit care, which we give to all stroke patients.’
Ultra-early surgery could improve outcomes
Ultra-early, minimally invasive surgery could improve ICH outcomes, Bruce says.
Previous surgery trials for ICH were not successful but potential reasons for this can be addressed. Bruce says ultra-early, minimally invasive intervention is critical.
‘Bleeding in the brain is caused by a ruptured artery. It’s a leaking pipe and the sooner you seal the pipe, the less blood leaks. We want to get in there early and fix the plumbing problem.
‘Hopefully we can reduce bleeding and growth in the blood clot it forms. That is what damages the brain and causes loss of function,’ Bruce explains.
To meet this need, Bruce and a team including Royal Adelaide Hospital neurologist Professor Tim Kleinig, and neurosurgeons Associate Professor Amal Abou-Hamden and Associate Professor John Laidlaw lead the EVACUATE randomised controlled trial of ultra-early, minimally invasive surgery for ICH.
Consumers want to reduce loss of function
The EVACUATE team worked with consumers on the trial design. Consumers emphasised that reducing deaths from ICH was not enough.
They want better treatments to reduce loss of function, giving stroke survivors a better quality of life.
The EVACUATE trial will test if stroke patients randomly assigned to receive ultra-early surgery have better outcomes than patients who receive the standard treatment.
Minimally invasive surgical technique
The trial uses a minimally invasive surgical technique to drill a small ‘burr hole’ in the patient’s skull. The surgeon inserts a SurgiScope probe via this burr-hole into the brain.
Guided by stereotactic navigation, registered to reference points from cross-section images of the brain, the surgeon locates the area of bleeding. The probe is used to remove the blood clot and stop vessels from continuing to bleed.
The biggest challenge is getting ICH patients to surgery fast enough
The blood clot grows in the first few hours after the stroke occurs, so it is critical to prioritise new ICH patients for immediate surgery.
Hospitals participating in the trial must change their admission systems to do this.
‘It’s a major effort,’ admits Bruce. ‘Unless you have proof that the technique works it’s hard to change the system. But you have to change the system a bit to get that proof.’
Jenni is changing the system at her hospital
Jenni is the link between the EVACUATE research team and the system at the Royal Adelaide Hospital.
‘I reviewed the trial protocol to ensure that it would be feasible from a nurse’s perspective.
'This involved mapping out how we could move acute stroke patients through the system and capture the data needed by the trial.’
Jenni is also the trial’s ‘blinded assessor’. She assesses patients 6 and 12 months after their stroke. Being a ‘blinded’ assessor means Jenni does not know if the patient received surgery or standard treatment.
Jenni contacts the patients to assess their functional quality of life. Her depth of experience as a carer for her dad after his stroke and a stroke researcher helps her know what to ask.
‘You might get somebody who says, “I don't play golf anymore because I just don't feel like going out with the girls.” But if you dig deeper you find out they don't play golf because they’ve lost function on their left side.’
Supporting Australia’s global leaders in stroke surgery
The EVACUATE trial team are global leaders in stroke surgery. Bruce previously led a team that proved surgery gives better results for treating the more common ischemic stroke. This is when a blood clot blocks the flow of blood to the brain. Bruce showed that surgery to remove the blood clot, thrombectomy, is more than twice as effective as clot-dissolving drugs used alone. For every 3 stroke patients who receive surgery an extra patient recovers their independence.
‘When we published that research in 2015 it revolutionised the way we treat ischemic stroke,’ Bruce remembers.
EVACUATE could revolutionise ICH stroke treatment
‘The EVACUATE trial is likely to make a huge change to ICH survivor outcomes around the globe,’ Jenni says.
‘Having lived this journey as a family member of the survivor of ICH stroke, I see its value. The excitement and anticipation of where this study could go is just huge!’
The Medical Research Future Fund supports the EVACUATE trial with funding of $2.1 million.