INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial.
INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial.
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DOI：
10.1186/s13063-021-05881-7
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发表时间：
2021-12-20
期刊：
影响因子：
2.5
通讯作者：
INTERACT3 investigators
中科院分区：
文献类型：
--
作者：
Song L;Hu X;Ma L;Chen X;Ouyang M;Billot L;Li Q;Muñoz-Venturelli P;Abanto C;Pontes-Neto OM;Antonio A;Wasay M;Silva A;Thang NH;Pandian JD;Wahab KW;You C;Anderson CS;INTERACT3 investigators
早期强化降压仍然是治疗急性脑出血(ICH)最有前景的治疗方法，尽管临床试验和控制血压的方法的治疗效果的潜在差异之间的结果并不一致。作为关于这一主题的一系列临床试验的第三项，急性脑出血重症监护捆绑降压试验(INTERACT3)旨在确定目标导向的护理捆绑方案在急性脑出血早期生理控制(强化降压、血糖控制和发热治疗)和抗凝逆转方面的有效性。INTERACT3是一项务实、国际化、多中心、阶梯式(4个阶段/3个步骤)的整群随机对照试验，旨在确定多方面护理包在急性脑出血(<；≥6 h发病)成人(年龄18 )患者(目标8360)中的有效性。该试验从中低收入国家的110家医院招募(平均每阶段19名连续患者)。控制阶段结束后，各医院实施干预措施(强化降压、目标收缩压及 140mmHg；血糖控制，无糖尿病组和有糖尿病组分别为6.1~7.8 /L和7.8~10.0 /L；退热治疗至目标体温≤37.5 °C；1 h内抗凝逆转、目标国际标准化比值及1.5)。将获得有关人口统计学和基线临床特征、医院管理和7天结果的信息。中央培训的盲人评估员将在6个 月时进行电话采访，以评估身体功能和与健康相关的生活质量。主要结果是用有序Logistic回归分析6个 月时的改良兰金量表(MRS)。在不同的假设下，8360名受试者的样本量提供了90%的力量(α=0.05)来检测干预的主要结果相对于对照标准护理的5.6%的绝对改善(转变)。作为急性脑出血最大的临床试验，INTERACT3正在按计划对一个广泛适用的目标导向的护理捆绑包的有效性进行评估，以应对尚未建立明显证明的治疗方法的严重情况。临床试验.gov NCT03209258。注册日期为2017年7月1日。中国审判登记处CHCTR-IOC-17011787。在线版本于2017年6月28日登记，载有补充材料，可在10.1186/s13063-021-05881-7查阅。
Early 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. INTERACT3 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. As 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. ClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017 The online version contains supplementary material available at 10.1186/s13063-021-05881-7.
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DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J
DOI：
10.1056/nejmoa1603460
发表时间：
2016-09-15
期刊：
The New England journal of medicine
影响因子：
--
作者：
Qureshi AI;Palesch YY;Barsan WG;Hanley DF;Hsu CY;Martin RL;Moy CS;Silbergleit R;Steiner T;Suarez JI;Toyoda K;Wang Y;Yamamoto H;Yoon BW;ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
通讯作者：
ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
影响因子：
8.2
作者：
An SJ;Kim TJ;Yoon BW
通讯作者：
Yoon BW
DOI：
10.1016/s1474-4422(18)30253-9
发表时间：
2018-10
期刊：
The Lancet. Neurology
影响因子：
--
作者：
Al-Shahi Salman R;Frantzias J;Lee RJ;Lyden PD;Battey TWK;Ayres AM;Goldstein JN;Mayer SA;Steiner T;Wang X;Arima H;Hasegawa H;Oishi M;Godoy DA;Masotti L;Dowlatshahi D;Rodriguez-Luna D;Molina CA;Jang DK;Davalos A;Castillo J;Yao X;Claassen J;Volbers B;Kazui S;Okada Y;Fujimoto S;Toyoda K;Li Q;Khoury J;Delgado P;Sabín JÁ;Hernández-Guillamon M;Prats-Sánchez L;Cai C;Kate MP;McCourt R;Venkatasubramanian C;Diringer MN;Ikeda Y;Worthmann H;Ziai WC;d'Esterre CD;Aviv RI;Raab P;Murai Y;Zazulia AR;Butcher KS;Seyedsaadat SM;Grotta JC;Martí-Fàbregas J;Montaner J;Broderick J;Yamamoto H;Staykov D;Connolly ES;Selim M;Leira R;Moon BH;Demchuk AM;Di Napoli M;Fujii Y;Anderson CS;Rosand J;VISTA-ICH Collaboration;ICH Growth Individual Patient Data Meta-analysis Collaborators
通讯作者：
ICH Growth Individual Patient Data Meta-analysis Collaborators
影响因子：
11
作者：
Song, Lili;Sandset, Else Charlotte;Anderson, Craig S.
通讯作者：
Anderson, Craig S.