INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial

Trials

Asita de Silva¹  Mohammad Wasay²  Kolawole Wasiu Wahab³  Octavio Marques Pontes-Neto⁴  Lu Ma⁵  Xin Hu⁵  Chao You⁵  Arauz Antonio⁶  Jeyaraj Durai Pandian⁷  Nguyen Huy Thang⁸  Carlos Abanto⁹  Lili Song^1,10  Menglu Ouyang^1,10  Craig S. Anderson^1,11  Laurent Billot^1,12  Xiaoying Chen^1,12  Qiang Li^1,12  Paula Muñoz-Venturelli^1,13 

[1] Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Colombo, Sri Lanka;Department of Medicine, The Aga Khan University, Karachi, Pakistan;Department of Medicine, University of Ilorin & University of Ilorin Teaching Hospital, Ilorin, Nigeria;Department of Neurology, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil;Department of Neurosurgery, West China Hospital, Sichuan University, NO.43, St. Guoxuexiang, Chengdu, China;Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez, Mexico City, Mexico;Neurology, Christian Medical College and Hospital, Ludhiana, India;Stroke Unit, 115 Hospital, Ho Chi Minh city, Vietnam;The Cerebrovascular Disease Research Center, National Institute of Neurological Sciences, Cercado de Lima, Peru;The George Institute China, Peking University Health Science Center, Room 011, Unit 2, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, China;The George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, King Street, 2042, Newtown, NSW, Australia;The George Institute China, Peking University Health Science Center, Room 011, Unit 2, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, China;The George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, King Street, 2042, Newtown, NSW, Australia;Department of Neurosurgery, West China Hospital, Sichuan University, NO.43, St. Guoxuexiang, Chengdu, China;Sydney Medical School, University of Sydney, Sydney, Australia;Department of Neurology, Royal Prince Alfred Hospital, Sydney, Australia;The George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, King Street, 2042, Newtown, NSW, Australia;The George Institute for Global Health, Faculty of Medicine, UNSW, Level 5, King Street, 2042, Newtown, NSW, Australia;Clinical Research Center, Faculty of Medicine, Clinica Alemana Universidad del Desarrollo, Santiago, Chile;

关键词: Stepped-wedge cluster-randomized trial;    Clinical trial;    Care bundle;    management;    Intracerebral hemorrhage;    Stroke;   

DOI  :  10.1186/s13063-021-05881-7

来源: Springer

【 摘 要 】

BackgroundEarly intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH.MethodsINTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions.DiscussionAs the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.Trial registrationClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017

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