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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Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke

2017 , Craig S. Anderson , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Laurent Billot , Maree L. Hackett , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , MUÑOZ VENTURELLI, PAULA ANDREA , BRUNSER RABOVICH, ALEJANDRO MICHEL , Bin Peng , Liying Cui , Lily Song , Kris Rogers , Sandy Middleton , Joyce Y. Lim , Denise Forshaw , C. Elizabeth Lightbody , Mark Woodward , Octavio Pontes-Neto , H. Asita De Silva , Ruey-Tay Lin , Tsong-Hai Lee , Jeyaraj D. Pandian , Gillian E. Mead , Thompson Robinson , Caroline Watkins

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Prognostic significance of early urinary catheterization after acute stroke: Secondary analyses of the international HeadPoST trial

2020 , Menglu Ouyang , Laurent Billot , Lili Song , Xia Wang , Christine Roffe , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Maree L Hackett , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , MUÑOZ VENTURELLI, PAULA ANDREA , Sandy Middleton , Octavio M Pontes-Neto , Tsong-Hai Lee , Caroline L Watkins , Thompson G Robinson , Craig S Anderson

Background An indwelling urinary catheter (IUC) is often inserted to manage bladder dysfunction, but its impact on prognosis is uncertain. We aimed to determine the association of IUC use on clinical outcomes after acute stroke in the international, multi-center, cluster crossover, Head Positioning in Acute Stroke Trial (HeadPoST). Methods Data were analyzed on HeadPoST participants (n = 11,093) randomly allocated to the lying-flat or sitting-up head position. Binomial, logistic regression, hierarchical mixed models were used to determine associations of early insertion of IUC within seven days post-randomization and outcomes of death or disability (defined as “poor outcome,” scores 3–6 on the modified Rankin scale) and any urinary tract infection at 90 days with adjustment of baseline and post-randomization management covariates. Results Overall, 1167 (12%) patients had an IUC, but the frequency and duration of use varied widely across patients in different regions. IUC use was more frequent in older patients, and those with vascular comorbidity, greater initial neurological impairment (on the National Institutes of Health Stroke Scale), and intracerebral hemorrhage as the underlying stroke type. IUC use was independently associated with poor outcome (adjusted odds ratio (aOR): 1.40, 95% confidence interval (CI): 1.13–1.74), but not with urinary tract infection after adjustment for antibiotic treatment and stroke severity at hospital separation (aOR: 1.13, 95% CI: 0.59–2.18). The number exposed to IUC for poor outcome was 13. Conclusions IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC.

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Head position and cerebral blood flow in acute ischemic stroke patients: Protocol for the pilot phase, cluster randomized, Head Position in Acute Ischemic Stroke Trial (HeadPoST pilot)

2016 , BRUNSER, ALEJANDRO , MUÑOZ VENTURELLI, PAULA ANDREA , LAVADOS GERMAIN, PABLO MANUEL , Javier Gaete , Sheila Martins , Hisatomi Arima , Craig S Anderson , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA

Rationale Few proven interventions exist for acute ischemic stroke (AIS), and most are expensive and restricted in applicability. Lying flat ‘head down’ positioning of AIS patients has been shown to increase by as much as 20%, mean cerebral blood flow velocities (CBFV) measured by transcranial Doppler (TCD) but whether this translates into clinical improvement is uncertain. Aim To determine if the lying flat position increases mean CBFV in the affected territory as compared to the sitting up position in AIS patients. Methods and design Head Position in Acute Ischemic Stroke Trial (HeadPoST pilot) is a cluster randomized (clusters being months), assessor-blinded end-point, phase IIb trial, where consecutive adults with anterior circulation AIS within 12 h of symptom onset are positioned to a randomized position for 48 h with TCD performed serially. Study outcomes Primary outcome is mean CBFV on TCD at 1 and 24 h after positioning. Secondary outcomes include: serious adverse events, neurological impairment at seven days, and death and disability at 90 days. Sample size estimates Assuming an increase of 8.3 (SD 11.4) cm/s in average of mean CBFV when tilted from 30° to 0°, 46 clusters are required (92 patients in total) to detect a 20% increase of mean CBFV with 90% power and 5% level of significance. Conclusion HeadPoST pilot is a cluster randomized multicenter clinical trial investigating the effect of head positioning on mean CBFV in anterior circulation AIS.

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Practice Patterns for Neurosurgical Utilization and Outcome in Acute Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials 1 and 2 Studies

2017 , Rui Guo , David J. Blacker , Xia Wang , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Richard I. Lindley , John Chalmers , Craig S. Anderson , Thompson Robinson

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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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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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Frequency, determinants, and effects of early seizures after thrombolysis for acute ischemic stroke: The ENCHANTED trial

2017 , Ying Xu , Maree L. Hackett , John Chalmers , Richard I. Lindley , Xia Wang , Qiang Li , Thompson Robinson , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Craig S. Anderson

AbstractBackground:Seizures after ischemic stroke have not been well-studied. We aim to determine the frequency, determinants, and significance of early seizures after thrombolysis for acute ischemic stroke.Methods:Data are from the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED), an international, multicenter, randomized controlled trial where patients with acute ischemic stroke were randomized to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) IV alteplase. The protocol prespecified prospective data collection on in-hospital seizures over 7 days postrandomization. Logistic regression models were used to determine variables associated with seizures and their significance on poor outcomes of death or disability (modified Rankin scale scores 3–6), symptomatic intracerebral hemorrhage (sICH), and European Quality of Life 5-Dimensions questionnaire [EQ-5D] over 90 days.Results:Data were available for 3,139 acute ischemic stroke participants, of whom 42 (1.3%) had seizures at a median 22.7 hours after the onset of symptoms. Baseline variables associated with seizures were male sex (odds ratio [OR] 2.19, 95% confidence interval [CI] 1.07–4.50), severe neurologic impairment (NIH Stroke Scale score ≥10; OR 2.16, 95% CI 1.06–4.40), and fever (OR 4.55, 95% CI 2.37–8.71). Seizures independently predicted poor recovery: death or major disability (OR 2.88, 95% CI 1.28–6.47), unfavorable ordinal shift of mRS scores (OR 1.94, 95% CI 1.10–3.39), and lower than median EQ-5D health utility index score (OR 3.50, 95% CI 1.37–8.91). There was no association of seizures with sICH in adjusted analysis.Conclusions:In thrombolysis-treated patients with acute ischemic stroke, seizures are uncommon, occur early, and predict poor recovery.Clinicaltrials.gov identifier:NCT01422616.

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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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Low blood pressure and adverse outcomes in acute stroke: HeadPoST study explanations

2020 , Menglu Ouyang , MUÑOZ VENTURELLI, PAULA ANDREA , Laurent Billot , Xia Wang , Lili Song , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Maree L. Hackett , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , BRUNSER, ALEJANDRO , Sandy Middleton , Octavio M. Pontes-Neto , Tsong-Hai Lee , Caroline L. Watkins , Thompson Robinson , Craig S. Anderson

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Regional variation in acute stroke care organisation

2016 , MUÑOZ VENTURELLI, PAULA ANDREA , Thompson Robinson , LAVADOS GERMAIN, PABLO MANUEL , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , Hisatomi Arima , Laurent Billot , Maree L. Hackett , Joyce Y. Lim , Sandy Middleton , Octavio Pontes-Neto , Bin Peng , Liying Cui , Lily Song , Gillian Mead , Caroline Watkins , Ruey-Tay Lin , Tsong-Hai Lee , Jeyaraj Pandian , H. Asita de Silva , Craig S. Anderson

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