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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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dc.contributor.author Song, L.
dc.contributor.author Hu, X.
dc.contributor.author Ma, L.
dc.contributor.author Chen, X.
dc.contributor.author Ouyang, M.
dc.contributor.author Billot, L.
dc.contributor.author Li, Q.
dc.contributor.author Muñoz-Venturelli, P.
dc.contributor.author Abanto, C.
dc.contributor.author Pontes-Neto, O.M.
dc.contributor.author Antonio, A.
dc.contributor.author Wasay, M.
dc.contributor.author de Silva, A.
dc.contributor.author Thang, N.H.
dc.contributor.author Pandian, J.D.
dc.contributor.author Wahab, K.W.
dc.contributor.author You, C.
dc.contributor.author Anderson, C.S.
dc.date.accessioned 2022-01-13T06:07:25Z
dc.date.available 2022-01-13T06:07:25Z
dc.date.issued 2021
dc.identifier.citation Trials.2021;22(1):943. en_US
dc.identifier.issn 1745-6215
dc.identifier.uri http://repository.kln.ac.lk/handle/123456789/24336
dc.description Indexed in MEDLINE en
dc.description.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. en_US
dc.language.iso en en_US
dc.publisher BioMed Central, London en_US
dc.subject Care bundle en_US
dc.subject Clinical trial en_US
dc.subject Intracerebral hemorrhage en_US
dc.title INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial en_US
dc.type Article en_US


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