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Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage
(2013)
Craig S. Anderson
;
Emma Heeley
;
Yining Huang
;
Jiguang Wang
;
Christian Stapf
Scopus© Citations 1333 1
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Statistical analysis plan for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): a large-scale investigation to solve longstanding controversy over the most appropriate management of elevated blood pressure in the hyperacute phase of intracerebral hemorrhage
(2013)
Craig Anderson
;
Emma Heeley
;
Stephane Heritier
;
Hisatomi Arima
;
Mark Woodward
The Statistical analysis plan (SAP) for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2).
2Scopus© Citations 10
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Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial
(2014)
Lisa Manning
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Yoichiro Hirakawa
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Hisatomi Arima
;
Xia Wang
;
John Chalmers
2Scopus© Citations 261
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Clinical Prediction Algorithm (BRAIN) to Determine Risk of Hematoma Growth in Acute Intracerebral Hemorrhage
(2015)
Xia Wang
;
Hisatomi Arima
;
Rustam Al-Shahi Salman
;
Mark Woodward
;
Emma Heeley
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage (ICH) to better inform clinicians and researchers in their efforts to improve outcomes for patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1 and 2, respectively). The study group was divided into a derivation cohort (INTERACT2, n=964) and a validation cohort (INTERACT1, n=346). Multivariable logistic regression was used to identify factors associated with clinically significant (≥6 mL) increase in hematoma volume at 24 hours after symptom onset. A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> A 24-point BRAIN score was derived from INTERACT2 (C-statistic, 0.73) based on baseline ICH volume (mL per score, ≤10=0, 10–20=5, >20=7), recurrent ICH (yes=4), anticoagulation with warfarin at symptom onset (yes=6), intraventricular extension (yes=2), and number of hours to baseline computed tomography from symptom onset (≤1=5, 1–2=4, 2–3=3, 3–4=2, 4–5=1, >5=0) predicted the probability of ICH growth (ranging from 3.4% for 0 point to 85.8% for 24 points) with good discrimination (C-statistic, 0.73) and calibration (Hosmer–Lemeshow <jats:italic>P</jats:italic> =0.82) in INTERACT1. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>The simple BRAIN score predicts the probability of hematoma growth in ICH. This could be used to improve risk stratification for research and clinical practice.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00226096 and NCT00716079. </jats:p> </jats:sec>
3Scopus© Citations 117
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Head Position in Stroke Trial (HeadPoST) - sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial
(2015)
MUÑOZ VENTURELLI, PAULA ANDREA
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Hisatomi Arima
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LAVADOS GERMAIN, PABLO MANUEL
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BRUNSER, ALEJANDRO
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Bin Peng
17Scopus© Citations 29
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Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study
(2016)
Danni Zheng
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Hisatomi Arima
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Shoichiro Sato
;
Antonio Gasparrini
;
Emma Heeley
1 1Scopus© Citations 24
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Mannitol and Outcome in Intracerebral Hemorrhage Propensity Score and Multivariable Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 2 Results
(2015)
Xia Wang
;
Hisatomi Arima
;
Jie Yang
;
Shihong Zhang
;
Guojun Wu
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Mannitol is often used to reduce cerebral edema in acute intracerebral hemorrhage but without strong supporting evidence of benefit. We aimed to determine the impact of mannitol on outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>INTERACT2 was an international, open, blinded end point, randomized controlled trial of 2839 patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated systolic blood pressure allocated to intensive (target systolic blood pressure, <140 mm Hg within 1 hour) or guideline-recommended (target systolic blood pressure, <180 mm Hg) blood pressure–lowering treatment. Propensity score and multivariable analyses were performed to investigate the relationship between mannitol treatment (within 7 days) and poor outcome, defined by death or major disability on the modified Rankin Scale score (3–6) at 90 days.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> There was no significant difference in poor outcome between mannitol (n=1533) and nonmannitol (n=993) groups: propensity score–matched odds ratio of 0.90 (95% confidence interval, 0.75–1.09; <jats:italic>P</jats:italic> =0.30) and multivariable odds ratio of 0.87 (95% confidence interval, 0.71–1.07; <jats:italic>P</jats:italic> =0.18). Although a better outcome was suggested in patients with larger (≥15 mL) than those with smaller (<15 mL) baseline hematomas who received mannitol (odds ratio, 0.52 [95% confidence interval, 0.35–0.78] versus odds ratio, 0.91 [95% confidence interval, 0.72–1.15]; <jats:italic>P</jats:italic> homogeneity <0.03 in propensity score analyses), the association was not consistent in analyses across other cutoff points (≥10 and ≥20 mL) and for differing grades of neurological severity. Mannitol was not associated with excess serious adverse events. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Mannitol seems safe but might not improve outcome in patients with acute intracerebral hemorrhage.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
6Scopus© Citations 53
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Poor utility of grading scales in acute intracerebral hemorrhage: results from the INTERACT2 trial
(2015)
Emma Heeley
;
Craig S. Anderson
;
Mark Woodward
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Hisatomi Arima
;
Thompson Robinson
<jats:sec><jats:title>Background</jats:title><jats:p> Several simple clinical grading scores have been developed for intracerebral hemorrhage, primarily to predict 30-day mortality. </jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p> We aimed to determine the accuracy of three popular scores (original intracerebral hemorrhage, modified intracerebral hemorrhage, and intracerebral hemorrhage grading scale) on 30-day mortality and 90-day death or major disability, and whether the magnitude of benefit varies according to prognosis graded by the three predictive scores. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Data from the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial which included 2839 intracerebral hemorrhage patients (<6 hours) and elevated systolic blood pressure (150–220 mmHg), randomized to intensive (target systolic blood pressure <140 mmHg) or guideline-based (<180 mmHg) blood pressure management. Discrimination of scales for predicting death and poor outcome (modified Rankin scale 3–6) was evaluated in area under receiver operator characteristic curves. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Among 2556 (90%) participants with available data, the modified intracerebral hemorrhage had the highest discrimination (receiver operator characteristic 0·75) for 90-day poor outcome compared with the original intracerebral hemorrhage (receiver operator characteristic 0·68) and intracerebral hemorrhage grading scale (receiver operator characteristic 0·69). All scores had good positive predictive value (approximately 80–90%) for poor outcome but poor sensitivity and positive predictive value for death. The scores do not clearly discriminate a patient group most likely to benefit from blood pressure lowering. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Intracerebral hemorrhage prognostic scores are not useful in defining patients at high probability of early death, but they are reliable for predicting poor outcome, defined by death or major disability. Potential benefits of early intensive blood pressure lowering are broadly applicable across grades of severity defined by such scores. </jats:p></jats:sec>
7Scopus© Citations 23
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Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage The INTERACT2 Study
(2016)
Anubhav Saxena
;
Craig S. Anderson
;
Xia Wang
;
Shoichiro Sato
;
Hisatomi Arima
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>We aimed to determine associations of baseline blood glucose and diabetes mellitus with clinical outcomes in participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>INTERACT2 was an international prospective, open, blinded end point, randomized controlled trial of 2839 patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated systolic blood pressure randomly assigned to intensive (target systolic blood pressure <140 mm Hg) or guideline-based (systolic blood pressure <180 mm Hg) BP management. Associations of hyperglycemia at presentation (>6.5 mmol/L) and combined and separate poor outcomes of death and major disability (scores of 3–6, 3–5, and 6, respectively, on the modified Rankin scale) at 90 days were determined in logistic regression models.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> In 2653 patients with available data, there were 1348 (61%) with hyperglycemia and 292 (11%) with diabetes mellitus. Associations of baseline blood glucose and poor outcome were strong and near continuous. After adjustment for baseline variables, the highest fourth (7.9–25.0 mmol/L) of blood glucose was significantly associated with combined poor outcome (adjusted odds ratio 1.35, 95% confidence interval 1.01–1.80; <jats:italic>P</jats:italic> trend 0.015). Diabetes mellitus also predicted poor outcome (adjusted odds ratio 1.46, 95% confidence interval 1.05–2.02; <jats:italic>P</jats:italic> =0.023), though more important for residual disability than death on separate analysis. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Hyperglycemia and diabetes mellitus are independent predictors of poor outcome in patients with predominantly mild to moderate severity of intracerebral hemorrhage. These data support guideline recommendations for good glycemic control in patients with intracerebral hemorrhage.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
5Scopus© Citations 118
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Prognostic Significance of Hyponatremia in Acute Intracerebral Hemorrhage: Pooled Analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies
(2016)
Cheryl Carcel
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Shoichiro Sato
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Danni Zheng
;
Emma Heeley
;
Hisatomi Arima
8Scopus© Citations 41

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