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. 2021 Dec 20;22(1):943.
doi: 10.1186/s13063-021-05881-7.

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

Lili Song #  1   2 , Xin Hu #  3 , Lu Ma #  3 , Xiaoying Chen  2 , Menglu Ouyang  1   2 , Laurent Billot  2 , Qiang Li  2 , Paula Muñoz-Venturelli  2   4 , Carlos Abanto  5 , Octavio Marques Pontes-Neto  6 , Arauz Antonio  7 , Mohammad Wasay  8 , Asita de Silva  9 , Nguyen Huy Thang  10 , Jeyaraj Durai Pandian  11 , Kolawole Wasiu Wahab  12 , Chao You  13 , Craig S Anderson  14   15   16   17   18 ; INTERACT3 investigators
Affiliations

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

Lili Song et al. Trials. .

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017.

Keywords: Care bundle; Clinical trial; Intracerebral hemorrhage; Stepped-wedge cluster-randomized trial; Stroke; management.

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Conflict of interest statement

CSA and LS declare that they received speaker fees and travel reimbursement from Takeda. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Stepped-wedge design
Fig. 2
Fig. 2
Study schema
See this image and copyright information in PMC

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