The 1st National Investigator Meeting of the INTERACT4 study held online
On 27 May 2021, the first National Investigator Meeting of the "Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial 4" (INTERACT4) was held online, co-organised by the George Institute for Global Health (China), Shanghai East Hospital of Tongji University and the First Affiliated Hospital of Chengdu Medical College. Participants included all co-Principal Investigators (PI) of the project: Professors Craig Anderson (the George Institute for Global Health China), Li Gang (Shanghai Oriental Hospital), and Yang Jie (The First Affiliated Hospital of Chengdu Medical College), together with other key members of the Steering Committee: Director Zhang Chunfang from Shanghai Pudong Medical Emergency Centre, Vice-President Wu Xiangjun from Guanghan People's Hospital, Director Xu Ping from Zigong the Fourth People's Hospital, and Head of INTERACT4 Coordination Centre Ms Yang Zhao (Stroke Section of The George Institute China), as well as site PIs and key research staff cross China.
The meeting began with a briefing on the progress on the project. According to Yang Zhao, INTERACT4 has now expanded to 82 sites nationwide since March 2020. Of these, 50 have received ethical approval and 33 are officially launched and implemented. The number of patients who have been screened to date has reached 1,636, with 458 of them enrolled; this represents an enrolment rate of 28%. The Data Safety and Monitoring Board (DSMB) has recommended that the study continue as planned, and the Academic Steering Committee (SC) and international advisory board have endorsed the study design based on the positive feasibility data.
To achieve faster and better blood pressure control from the intervention, Dr Guo Yijia from the First Affiliated Hospital of Chengdu Medical College, and Dr Chen Chen from Shanghai East Hospital, provided training guidance on how patients can have their blood pressure managed in the ambulance and for effective transfer of care over to hospital staff. Dr Guo Yijia explained that the traditional emergency model is to scramble to transport patients as quickly as possible to hospital, whereas such pre-hospital research is about incorporating some additional procedures and interventions as efficiently as possible within a short time window. This makes it important for emergency vehicle staff to be appropriately trained and feel confident in procedures and managing participants, and for there to be a smooth handover of care from emergency vehicles to the hospital. Guo Yijia emphasised that “through the nearly one year of conducting the study, we have confirmed that pre-hospital research can be done well and is feasible in China.”
The experience of the INTERACT4 Research Centres of Excellence proved this to be true. At the conference, Director Zhang Chunfang from Shanghai Pudong New Area Medical Emergency Centre, Professor Li Gang from Shanghai East Hospital, Vice President Wu Xiangjun from Guanghan People's Hospital and Director Xu Ping from Zigong the Fourth People's Hospital, all shared their experiences of managing the respective centres.
The Shanghai Pudong New Area Medical Emergency Centre is known for its orderly management and abundant number of enrolments. Director Zhang Chunfang emphasised that rapid response, accurate judgement, standardised treatment, timely transfer are the core elements. Repeated training, supervision and management, the use of the WeChat platform for patient handover management and the electronic information collection system to collect pre-hospital data are the “secrets” of the centre's success in conducting the study.
The Shanghai East Hospital was ranked the first, both in the numbers of enrolment and the quality of the study. Professor Li Gang's team shared their experience by introducing the methods of in-hospital quality control. One of the first steps of good in-hospital quality control is to notify the emergency physicians about the enrolment at the first time. This is followed by a dedicated person, a reasonable division of labour according to where the patient is going, and a detailed blood pressure management process.
The Guanghan People's Hospital was selected as "dark horse" for enrolment, from the initial "zero cases" to the "excellent group centre". President Wu Xiangjun believes that multidisciplinary collaboration and repeated training are key. He also emphasised that a clinician’s time schedule is a valuable resource. It is crucial to optimise the process to save the time of emergency physicians, but also to ensure the quality of the study and to control the relevant aspects.
The Zigong Fourth People's Hospital has the best blood pressure management and the Emergency Department is also the lead department of the INTERACT4 study. In his presentation, Director Xu Ping emphasized that the centre's complete emergency system and that a well-supported emergency centre as key to the success of any hospital. Furthermore, the design of INTERACT4 was very reasonable, from patient enrolment to patient blood pressure interventions, as well as the teamwork which together ensures the hospital's success.
Introducing the study design, Professor Li Gang said, "The original concept of INTERACT4 is inseparable from the construction of our stroke emergency system. This study is not characterised by drug treatment, but by blood pressure control, and is purely scientific research, during which it has been difficult to go through the COVID-19 pandemic. I thank everyone for your persistence and contribution. "
Professor Yang Jie particularly thanked the sub-centres for their support: "We thank the top ten centres in terms of the number of patients enrolled, who have made a lot of exploration and fruitful work. I hope that we can build on this and go further."
Professor Craig Anderson likens the research to an exciting adventure: "We need to have a good map, which is a protocol; a good team for support, and good resources to ensure that we achieve our goal at the end of this adventure. INTERACT4 is like that. There are very few randomized controlled trials that have been conducted in the ambulance pre-hospital setting and we're trying to determine whether early intensive blood pressure lowering will benefit patients. Not just in China, but across the world.”