The George Institute for Global Health today announced data from the phase III INTERACT3 study demonstrating that a new combination of treatments for stroke due to intracerebral haemorrhage (ICH) significantly improves the chances of surviving without major disability. Results were presented today at the European Stroke Organisation Conference in Munich, Germany, and simultaneously published in The Lancet.
The INTERACT3 study is the first-ever randomised controlled trial to show a clearly positive outcome for the treatment of ICH. Timely administration of the new treatment protocol – known as a Care Bundle – centred on the rapid control of high blood pressure, led to improved recovery, lower rates of death, and better overall quality of life in patients with this serious condition.
Professor Craig Anderson, Director of Global Brain Health at The George Institute and a senior author of the research said, “Despite the high rates of ICH and its severity, there are few proven options for treating it, but early control of high blood pressure is the most promising. Time is critical when treating this type of stroke, so we tested a combination of interventions to rapidly stabilise the condition of these patients to improve their outcomes. We estimate that if this protocol was universally adopted, it could save tens of thousands of lives each year around the world.”
Commonly referred to as a haemorrhagic stroke or brain bleed, ICH is the second most common type of stroke and also the most deadly, with 40% to 50% of patients dying within 30 days. It occurs when blood leaks out of a blood vessel into the brain tissue and represents over a quarter of all cases of stroke, affecting approximately 3.4 million people a year.
In the INTERACT3 study, over 7,000 patients were enrolled across 144 hospitals in 10 countries – nine middle-income countries and one high-income country.
The research team evaluated the effectiveness of the new Care Bundle, which included early intensive lowering of systolic blood pressure, strict glucose control, fever treatment, and rapid reversal of abnormal anticoagulation.
They found that using this new treatment protocol compared to usual care reduced the likelihood of a poor functional outcome, including death, after six months. This was estimated to prevent one additional death for every 35 patients treated.
Central to this was a rapid reduction in systolic blood pressure, where target levels were achieved, on average, in 2.3 hours [range 0.8 to 8.0hrs], compared to 4.0 hours [range 1.9 to 16.0hrs] in the control group. The interventional protocol resulted in a statistically significant reduction in mortality, number of serious adverse events, and time spent in hospital, as well as demonstrating an improvement in health-related quality of life.
The burden of ICH is greatest in low- and middle-income countries. In 2019, 30% of all stroke cases in LMICs were ICH, almost double the proportion seen in high-income countries (16%). This is in part due to high rates of hypertension and limited resources for primary prevention strategies, including identification and management of stroke risk factors by healthcare services.
Dr Lili Song, joint lead author and Head of the Stroke Program at The George Institute China, said, “A lack of proven treatments for ICH has led to a pessimistic view that not much can be done for these patients. However, with INTERACT3, we demonstrate on a large scale how readily available treatments can be used to improve outcomes in resource-limited settings. We hope this evidence will inform clinical practice guidelines across the globe and help save many lives.”
Method of Research
Randomized controlled/clinical trial
Subject of Research
The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial
Article Publication Date
LS reports funding from the Medical Research Council of the UK, Sichuan Credit Pharmaceutic, and Takeda China; and speaker fees from Takeda China. CSA has received grants from the National Health and Medical Research Council and Medical Research Futures Fund of Australia, the Medical Research Council of the UK, Penumbra, and Takeda China; is also the chair of the data and safety monitoring boards for several trials; is a board member of WHO; and is the Editor-in-Chief of Cerebrovascular Disease. CY has received funding from West China Hospital. All other authors declare no competing interests.