LAVADOS GERMAIN, PABLO MANUEL
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LAVADOS GERMAIN, PABLO MANUEL
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p.lavados@udd.cl
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57188955599

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Significance of Hematoma Shape and Density in Intracerebral Hemorrhage The Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial Study

2016 , Candice Delcourt , Shihong Zhang , Hisatomi Arima , Shoichiro Sato , Rustam Al-Shahi Salman , Xia Wang , Leo Davies , Christian Stapf , Thompson Robinson , LAVADOS GERMAIN, PABLO MANUEL , John Chalmers , Emma Heeley , Ming Liu , Richard I. Lindley , Craig S. Anderson

Background and Purpose— In patients with acute intracerebral hemorrhage (ICH), the shape and density of the hematoma are associated with its subsequent growth, but the impact of these parameters on clinical outcome is uncertain. Methods— Baseline computed tomographic scans and clinical data were obtained in the Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial (INTERACT2). Three independent neurologists blind to clinical data assessed ICH for shape and density using a previously described scale. Shape was defined as irregular when the ICH had ≥2 extra lesions added to the ellipsoid-shaped ICH. Density was heterogeneous when there were ≥3 low-density lesions within the ICH. Outcome measures were death and major disability (modified Rankin scale score of 3–5), combined and separate at 90-day postrandomization. Multivariable logistic regression models were used to determine the significance of hematoma characteristics on outcome. Results— There were 2066 patient computed tomographic scans included in the analysis, with 46% and 38% having irregular and heterogeneous ICH, respectively. Irregular shape was independently associated with death/major disability (adjusted odds ratio, 1.60; 95% confidence interval [CI], 1.29–1.98) and major disability alone (adjusted odds ratio, 1.60; 95% CI, 1.31–1.95), but not with death alone (adjusted odds ratio, 0.97; 95% CI, 0.68–1.39). Heterogeneous density was not associated with clinical outcomes (adjusted odds ratio, 1.06; 95% CI, 0.85–1.33), 1.04 (95% CI, 0.73–1.48), and 1.14 (95% CI, 0.93–1.39), respectively, for death/major disability, death alone, and disability alone). Conclusions— Irregular shape, but not heterogeneous density, is independently associated with poor outcome after ICH. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00716079.

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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 , Yoichiro Hirakawa , Hisatomi Arima , Xia Wang , John Chalmers , Jiguang Wang , Richard Lindley , Emma Heeley , Candice Delcourt , Bruce Neal , Pablo Lavados , Stephen M Davis , Christophe Tzourio , Yining Huang , Christian Stapf , Mark Woodward , Peter M Rothwell , Thompson G Robinson , Craig S Anderson

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Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage

2016 , Shoichiro Sato , Candice Delcourt , Emma Heeley , Hisatomi Arima , Shihong Zhang , Rustam Al-Shahi Salman , Christian Stapf , Daniel Woo , Matthew L. Flaherty , Achala Vagal , Christopher Levi , Leo Davies , Jiguang Wang , Thompson Robinson , LAVADOS GERMAIN, PABLO MANUEL , Richard I. Lindley , John Chalmers , Craig S. Anderson

Background and Purpose— The significance of structural changes associated with cerebral small-vessel disease (SVD), including white matter lesions (WML), lacunes, and brain atrophy, to outcome from acute intracerebral hemorrhage is uncertain. We determined associations of computed tomographic radiological manifestations of cerebral SVD and outcomes, and in terms of any differential effect of early intensive blood pressure–lowering treatment, in the large-scale Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). Methods— We graded WML (van Swieten scale), the presence of lacunes, and brain atrophy (2 linear measurements and visual rating) for 2069 of 2839 patients with available baseline brain computed tomography (<6 hours of intracerebral hemorrhage onset) by 3 independent neurologists blind to clinical data. Results— WML grade and 2 linear measurements of brain atrophy were associated with death or major disability at 90 days: multivariable-adjusted odds ratios for WML (grade 3 and 4 versus 0), frontal ratio, and third ventricle Sylvian fissure distance (most versus least severe atrophy quartile) were 1.42 (95% confidence interval, 1.02–1.98), 1.47 (1.08–1.99), and 1.64 (1.21–2.22), respectively (all P for trend <0.05). There was no association between lacunes and outcomes. There were no significant differences in the effects of intensive blood pressure–lowering across subgroups of cerebral SVD. Conclusions— Preexisting cerebral SVD manifestations of WML and brain atrophy predict poor outcome in acute intracerebral hemorrhage. There is no apparent hazard of early intensive lowering of blood pressure according to the INTERACT2 protocol, in patients with underlying cerebral SVD. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00716079.

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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 , Mark Woodward , MUÑOZ VENTURELLI, PAULA ANDREA , LAVADOS GERMAIN, PABLO MANUEL , Christian Stapf , Thompson Robinson , Emma Heeley , Candice Delcourt , Richard I. Lindley , Mark Parsons , John Chalmers , Craig S. Anderson

Background and Purpose— 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). Methods— 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. Results— 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; P =0.30) and multivariable odds ratio of 0.87 (95% confidence interval, 0.71–1.07; P =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]; P 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. Conclusions— Mannitol seems safe but might not improve outcome in patients with acute intracerebral hemorrhage. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00716079.

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Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study

2016 , Danni Zheng , Hisatomi Arima , Shoichiro Sato , Antonio Gasparrini , Emma Heeley , Candice Delcourt , Serigne Lo , Yining Huang , Jiguang Wang , Christian Stapf , Thompson Robinson , Pablo Lavados , John Chalmers , Craig S. Anderson , Xiaoying Wang

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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 , Candice Delcourt , Richard Lindley , Thompson Robinson , LAVADOS GERMAIN, PABLO MANUEL , Bruce Neal , Jun Hata , Hisatomi Arima , Mark Parsons , Yuechun Li , Jinchao Wang , Stephane Heritier , Qiang Li , Mark Woodward , R. John Simes , Stephen M. Davis , John Chalmers

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Withdrawal of active treatment after intracerebral haemorrhage in the INTERACT2 study

2017 , MUÑOZ VENTURELLI, PAULA ANDREA , Xia Wang , Darin B. Zahuranec , LAVADOS GERMAIN, PABLO MANUEL , Christian Stapf , Richard Lindley , Candice Delcourt , John Chalmers , Craig S. Anderson , Thompson G. Robinson , Thompson G. Robinson

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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 , Christian Stapf , LAVADOS GERMAIN, PABLO MANUEL , Thompson Robinson , Yining Huang , Jiguang Wang , Candice Delcourt , Craig S. Anderson

Background and Purpose— 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. Methods— 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. Results— 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 P =0.82) in INTERACT1. Conclusions— 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. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00226096 and NCT00716079.

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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 , Richard Lindley , Bruce Neal , Yining Huang , Ji-Guang Wang , Mark Parsons , Christian Stapf , Tom Robinson , LAVADOS GERMAIN, PABLO MANUEL , Candice Delcourt , Stephen Davis , John Chalmers

The Statistical analysis plan (SAP) for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2).

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Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2

2020 , Else Charlotte Sandset , Xia Wang , Cheryl Carcel , Shoichiro Sato , Candice Delcourt , Hisatomi Arima , Christian Stapf , Thompson Robinson , LAVADOS GERMAIN, PABLO MANUEL , John Chalmers , Mark Woodward , Craig S Anderson

Introduction Reports vary on how sex influences the management and outcome from acute intracerebral haemorrhage. We aimed to quantify sex disparities in clinical characteristics, management, including response to blood pressure lowering treatment, and outcomes in patients with acute intracerebral haemorrhage, through interrogation of two large clinical trial databases. Patients and Methods Post-hoc pooled analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2, where patients with a hypertensive response (systolic, 150–220 mmHg) after spontaneous intracerebral haemorrhage (<6 h) were randomised to intensive (target <140 mmHg <1 h) or guideline-recommended (<180 mmHg) blood pressure lowering treatment. The interaction of sex on early haematoma growth (24 h), death or major disability (modified Rankin scale scores 3–6 at 90 days), and effect of randomised treatment were determined in multivariable logistic regression models adjusted for baseline confounding variables. Results In 3233 participants, 1191 (37%) were women who were significantly older, had higher baseline National Institutes of Health Stroke Scale scores and smaller haematoma volumes compared to men. Men had higher three-month mortality (odds ratio 1.48, 95% confidence interval 1.10–2.00); however, there was no difference between women and men in the combined endpoint of death or major disability. There were no significant sex differences on mean haematoma growth or effect of randomised blood pressure lowering treatment. Discussion Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had more comorbidities, larger baseline haematoma volumes and higher mortality after adjustment for age, as compared with women. Conclusion Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had a greater odds of dying after intracerebral haemorrhage than women, which could not be readily explained by differing casemix or patterns of blood pressure management. Clinical trial registration The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079).

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