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

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dc.contributor.authorSong, Lili
dc.contributor.authorHu, Xin
dc.contributor.authorMa, Lu
dc.contributor.authorChen, Xiaoying
dc.contributor.authorOuyang, Menglu
dc.contributor.authorBillot, Laurent
dc.contributor.authorLi, Qiang
dc.contributor.authorMuñoz Venturelli, Paula
dc.contributor.authorAbanto, Carlos
dc.contributor.authorPontes-Neto, Octavio M.
dc.contributor.authorArauz, Antonio
dc.contributor.authorWasay, Mohammad
dc.contributor.authorSilva, Asita de
dc.contributor.authorNguyen, Huy Thang
dc.contributor.authorPandian, Jeyaraj Durai
dc.contributor.authorWahab, Kolawole Wasiu
dc.contributor.authorYou, Chao
dc.contributor.authorAnderson, Craig S.
dc.contributor.authorINTERACT3 investigators
dc.date.accessioned2021-12-21T19:24:48Z
dc.date.available2021-12-21T19:24:48Z
dc.date.issued2021
dc.description.abstractBackground: 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), clusterrandomized 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 NCT03es
dc.identifier.citationSong, L., Hu, X., Ma, L. et al. 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 22, 943 (2021). https://doi.org/10.1186/s13063-021-05881-7es
dc.identifier.urihttps://doi.org/10.1186/s13063-021-05881-7es
dc.identifier.urihttp://hdl.handle.net/11447/5262
dc.language.isoenes
dc.subjectStepped-wedge cluster-randomized triales
dc.subjectClinical triales
dc.subjectCare bundlees
dc.subjectManagementes
dc.subjectIntracerebral hemorrhagees
dc.subjectStrokees
dc.titleINTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge clusterrandomized controlled triales
dc.typeArticlees
dcterms.sourceTrialses

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