Meeting the need for speed in stroke research
It was Hippocrates, the ‘father of modern medicine’, who first identified stroke some 2,400 years ago. It was then called apoplexy, a Greek word meaning ‘struck down by violence’. Fast forward through the ages and for the 1.2 million stroke survivors in the UK today, this striking description is one they will likely recognise. Stroke is the fourth biggest killer and a leading cause of disability in the UK. This is why stroke research matters.
Enter INTERACT 2, an international study, supported by the National Institute for Health Research (NIHR) and focusing on the least treatable form of stroke: acute intracerebral haemorrhage. This is when blood suddenly bursts into brain tissue, causing damage to the brain. Often what then follows, is a significant rise in blood pressure, leading to greater chance of disability and death. Professor Tom Robinson, the National Specialty Lead for Stroke for the NIHR Clinical Research Network and the study’s UK Chief Investigator explains more: “One of the reasons that people do badly in haemorrhage is that they re-bleed, and if they re-bleed they tend to do that very early. It’s felt that one of the causes of re-bleeding is sustained high blood pressure.”
The aim of INTERACT 2 was to determine the safety and effectiveness of intensive lowering of blood pressure in patients with intracerebral haemorrhage, and whether this would improve patient outcomes. The NIHR delivered the study across 20 sites in England and met its recruitment target of 70 participants within the allocated time. While the study did not result in a significant reduction in the rate of death or major disability, it did lead to a change in guidelines in the United States, Europe and the UK. Now, anybody that presents to hospital within six hours of haemorrhagic stroke should be treated to bring their blood pressure down (<140mmHg) as soon as possible, within an hour, and to maintain it there for at least 24 hours.
But what does this mean for patients? “Overall they will have a better outcome. Historically in stroke trials, the outcome reported has been split between dead and dependent versus independent. Of course, doctors and more importantly patients, are more interested in not just being alive but being alive with a better quality of life, explains Professor Robinson.
“Being dependent covers from 24-hour nursing care, through daily help with washing and dressing to weekly help, perhaps to shop; and so considering the whole range is important to determining overall quality of life.
“Therefore, whilst INTERACT 2 did not show a significant change in death and major disability, overall there was a change to less dependency, reflected in the change to guidelines.”
The NIHR is clearly a crucial link in the chain of improving patient care and quality of life but the benefits don’t end there. Studies such as INTERACT 2 could also put a significant dent in the NHS and social care bill, which for stroke currently stands at £1.7 billion a year in England.
“If people are less disabled they have shorter lengths of stay and are likely to need less nursing and social care when they leave hospital. If people are better after their stroke, the long term cost to society, and importantly patients and their families, is less,” says Professor Robinson.
When it came to getting people to take part in INTERACT 2, the NIHR recruited more participants than the vast majority of European countries, this despite coming late to the study. Something Professor Robinson believes is testament to the NIHR infrastructure.
“We have stroke centres who admit high volumes of stroke patients, who have dedicated research staff, who are there to recruit to well designed, randomised, control trials and studies. This study showed that we could contribute to large, international academic studies in a very timely fashion. It just put us on the map’.
Indeed, off the back of INTERACT 2 a string of further successful international stroke studies followed. “Having that infrastructure in place made a definite difference,’ says Professor Robinson, ‘It has helped make the UK a ‘go-to’ country for hyperacute stroke studies.”
But it’s not all plain sailing when there is a need for speed. “Questions need answering quickly,” says Professor Robinson.
“There remain challenges with getting people into studies, a lot of which we can’t control: patients and families recognising stroke, ambulance staff transferring patients to hospital quickly, patients being assessed and scanned speedily on arrival to hospital, and then patients and relatives being spoken to about consent into the trial; all as soon as possible, and preferably within a six-hour window.”
Professor Robinson is keen to highlight the contribution of patients, carers and the public, who he says “have been instrumental in getting involved in regulating and undertaking research so they understand the need to give enough information in the information sheet, without overwhelming people when their relatives are critically ill.” In short, a more patient friendly summary of the study has proved to be a huge time saver.
While recent years have seen huge improvements in the clinical management of people with stroke, with early assessment, use of thrombolysis (clot-busting treatment) and better organisation of services into acute stroke, Professor Robinson is clear: “The only way that we move forward is to research. It’s not a process that should ever stop.”
Right now people being cared for in the NHS are benefiting from past research, and will continue to benefit from research that’s currently being carried out. So those for who choose to take part in research today, it is this gift to future generations that is one of the big attractions. “You can’t promise benefit to the patient and the family involved because you are testing something,” says Professor Robinson.
“However, we now have many patients affected by stroke, who have taken part in research and now are the greatest ambassadors for research, helping set new priorities, review research proposals, support the design and management of studies, and importantly help communicate the results of these studies to participants.”