INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial

Trials

for the INTERACT4 investigators¹  Thompson Robinson²  Jie Yang³  Yapeng Lin³  Yijia Guo³  Else Charlotte Sandset⁴  Feifeng Liu⁵  Gang Li⁵  Gary A. Ford⁶  Chunfang Zhang⁷  Philip M. Bath⁸  Nikola Sprigg⁸  Chen Chen⁹  Craig S. Anderson⁹  Lili Song⁹  Laurent Billot^1,10  Hisatomi Arima^1,10  Lei Si^1,10  Xiaoying Chen^1,10  Qiang Li^1,10  Menglu Ouyang^1,10  Hueiming Liu^1,10  H. Bart van der Worp^1,11  Jeffrey L. Saver^1,12 

[1] ;College of Life Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester;Department of Neurology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College;Department of Neurology, Oslo University Hospital;Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University;Oxford University Hospitals NHS Foundation Trust and University of Oxford;Shanghai Pudong New Area Medical Emergency Center;Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham;The George Institute China, Peking University Health Science Center;The George Institute for Global Health, Faculty of Medicine, UNSW;University Medical Center;University of California;

关键词: Stroke;    Pre-hospital;    Blood pressure;    Ambulance;    Management;    Clinical trial;   

DOI  :  10.1186/s13063-021-05860-y

来源: DOAJ

【 摘 要 】

Abstract Background Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

【 授权许可】

Unknown