OLAVARRIA IANISZEWSKY, VERONICA VIVIANA
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OLAVARRIA IANISZEWSKY, VERONICA VIVIANA
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OLAVARRIA IANISZEWSKY, VERONICA VIVIANA
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v.olavarria@udd.cl
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57204794060

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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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Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study

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

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Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience

2021 , Xia Wang , Tom J. Moullaali , Menglu Ouyang , Laurent Billot , Else Charlotte Sandset , Lili Song , Candice Delcourt , Maree L. Hackett , Caroline L. Watkins , Thompson G. Robinson , Jie Yang , LAVADOS GERMAIN, PABLO MANUEL , BRUNSER, ALEJANDRO , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , MUÑOZ VENTURELLI, PAULA ANDREA , Hisatomi Arima , Sandy Middleton , Octávio M. Pontes-Neto , Jeyaraj Durai Pandian , Kris Rogers , Craig S. Anderson

<b><i>Background:</i></b> Patients with premorbid functional impairment are generally excluded from acute stroke trials. We aimed to determine the impact of including such patients in the Head Positioning in acute Stroke Trial (HeadPoST) and early additional impairment on outcomes. <b><i>Methods:</i></b> Post hoc analyses of HeadPoST, an international, cluster-randomized crossover trial of lying-flat versus sitting-up head positioning in acute stroke. Associations of early additional impairment, defined as change in modified Rankin scale (mRS) scores from premorbid levels (estimated at baseline) to Day 7 (“early ΔmRS”), and poor outcome (mRS score 3–6) at Day 90 were determined with generalized linear mixed model. Heterogeneity of the trial treatment effect was tested according to premorbid mRS scores 0–1 versus 2–5. <b><i>Results:</i></b> Of 8,285 patients (38.9% female, mean age 68 ± 13 years) with complete data, there were 1,984 (23.9%) with premorbid functional impairment (mRS 2–5). A significant linear association was evident for early ∆mRS and poor outcome (per 1-point increase in ΔmRS, adjusted odds ratio 1.20, 95% confidence interval 1.14–1.27; <i>p</i> &#x3c; 0.0001). Patients with greater premorbid functional impairment were less likely to develop additional impairment, but their risk of poor 90-day outcome significantly increased with increasing (worse) premorbid mRS scores (linear trend <i>p</i> &#x3c; 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. <b><i>Conclusions:</i></b> Early poststroke functional impairment that exceeded premorbid levels was associated with worse 90-day outcome, and this association increased with greater premorbid functional impairment. Yet, including premorbid impaired patients in the HeadPoST did not materially affect the subsequent treatment effect. <b><i>Clinical Trial Registration:</i></b> HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017).

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Low-Dose versus Standard-Dose Intravenous Alteplase in Acute Ischemic Stroke

2016 , Craig S. Anderson , Thompson Robinson , Richard I. Lindley , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , Tsong-Hai Lee , Joseph P. Broderick , Xiaoying Chen , Guofang Chen , Vijay K. Sharma , Jong S. Kim , Nguyen H. Thang , Yongjun Cao , Mark W. Parsons , Christopher Levi , Yining Huang , Verónica V. Olavarría , Andrew M. Demchuk , Philip M. Bath , Geoffrey A. Donnan , Sheila Martins , Octavio M. Pontes-Neto , Federico Silva , Stefano Ricci , Christine Roffe , Jeyaraj Pandian , Laurent Billot , Mark Woodward , Qiang Li , Xia Wang , Jiguang Wang , John Chalmers

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No benefit of flat head positioning in early moderate–severe acute ischaemic stroke: a HeadPoST study subgroup analysis

2020 , BRUNSER, ALEJANDRO , Menglu Ouyang , Hisatomi Arima , Pablo M Lavados , Thompson Robinson , MUÑOZ VENTURELLI, PAULA ANDREA , Verónica V Olavarría , Laurent Billot , Marre L Hackett , Lili Song , Sandy Middleton , Octavio Pontes-Neto , Tsong-Hai Lee , Caroline Watkins , Craig S Anderson

BackgroundAlthough the Head Positioning in acute Stroke Trial (HeadPoST) showed no effect of the flat head position (FP; vs sitting up head position (SUP)) on functional outcome, we hypothesised that it could still offer benefits if commenced early in those with acute ischaemic stroke (AIS) of at least moderate severity.MethodsSubgroup analysis of HeadPoST in participants with National Institutes of Health Stroke Scale (NIHSS) scores ≥7, ≥10 and ≥14, randomised to FP or SUP <4.5 hours of AIS onset on functional outcomes defined by a shift in scores on the modified Rankin scale (mRS) and death/disability (mRS scores 3–6), and any cardiovascular serious adverse event. Logistic regression analyses were undertaken adjusted for study design and baseline risk factors.ResultsThere was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3–6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04); NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19); NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14).ConclusionsEarly FP had no significant effect in patients with moderate–severe AIS.Trial registration numberNCT02162017.

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Impact of Evidence‐Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study

2019 , MUÑOZ VENTURELLI, PAULA ANDREA , Xian Li , Sandy Middleton , Caroline Watkins , LAVADOS GERMAIN, PABLO MANUEL , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , BRUNSER, ALEJANDRO , Octavio Pontes‐Neto , Taiza E. G. Santos , Hisatomi Arima , Laurent Billot , Maree L. Hackett , Lily Song , Thompson Robinson , Craig S. Anderson , Gillian Mead , H. Asita De Silva , Jeyaraj D. Pandian , Ruey‐Tay Lin , Tsong‐Hai Lee , Liying Cui , Bin Peng , Stephane Heritier , Richard Lindley , Stephen Jan , Elizabeth Boaden , Christopher P. L. H. Chen , Anne Forster , Laurent Billot , Mark Woodward , Kris Rogers , Anish Scaria , Joyce Y. Lim , Natalie Espinosa , Lucy McEvoy , Lee Blackburn , Sarah S. Richtering , Shoujiang You , Simon Ladwig , Gabrielle P. Merritt , Bryce Thomsen , Kerry Jenson , Penelope Gordon , Dennis Ryan Nguyen , Wei Wei Quan , Tessa Pei‐Yi Lo , Jonathan Lim , Selena Goh , Leibo Liu , Mirza Ahmad Baig , Ravider Singh , Paul Donnelly , Manuela Armenis , Marna Van Zyl , Helen Monaghan , Phillipa Smith , Parisa Glass , Fanli Zhou , Yun Shen , Li Lei , Di Li , Ting Zhang , Xiaoyan Zhang , Yun Peng , Lingling Feng , Zhiping Ye , Philip Gregory , Jeyaraj D. Pandain , Deepti Arora , Pablo M. Lavados , GONZALEZ, FRANCISCA , Bernardita Portales , Octavio Pontes‐Neto , Taiza Santos‐Pontelli , Brunna Rimoli , Monica Braga , Carolina Vidal , Dafna Benadof , Rodrigo J. Rivas , Laura Carvallo , Pamela Carvallo , Rubia Miranda , Brunna Pileggi , H. Asita de Silva , Shalomi Weerawardena , Thanushanthan Jeevarajah , Devaki Dharmawardena , Dumindi Ranasinghe , Matheesha Dharshana , Nilesh Nandadeva , Savithri Nawarathna , Ruey‐Tay Lin , Tsong‐Hai Lee , Jiu‐Haw Yin , Shoou‐Jeng Yeh , Ruei‐Jen Ma , Caroline L. Watkins , Gemma Whiteley , Denise Forshaw , Catherine Elizabeth Lightbody , Joanna Cox , Jane Fitzgerald , John F. Heney , Helen Byfield , Simone Finley , Hayley E. Tyrer , Carole Bruce , Alison Gibbon , Brett Jones , Emma Siracusa , Koushik Gowda , Shahla Cowans , Briana Forman , Sherin Jacob , Kristine Caprecho , Roshan Khatri , Po Yi Wan , Maria Lopez , Sifiso Vanika , Wilhelmina Bleeker , Marinka Ireland , Sheila Jala , Susan Day , Eric Ha , Martin Krause , Melissa Passer , Sarah Giaccari , Nadia Burkolter , Michael Braithwaite , Kylie Tastula , Darshan Ghia , Tapuwa Musuka , Anthony Alvaro , Gillian Edmonds , Nicole O'Loughin , Rebecca Phair , Joanne Kaoutal , David J. Blacker , Belinda L Saint , Kim Parrey , Michelle Coad , Matthew Kinchington , Nishantha Senanayake , Johanna Alaban , Irma Kuehne , Taiza Santos‐Pontelli , Monica Braga , Brunna Rimoli , Millene Camilo , Milena Libardi , Sheila Martins , Batista Carlos , Magda Martins , Leonardo Carbonera , Andrea Almeida , Martin Kelin , Carla Pauli , Mariana Lunardi , Luciane Silveira , Olga Chagas , Daily Souza , Gabriel Braga , Priscila Ribeiro , Gustavo Luvizutto , Marcia Polin , Fernanda Winckler , Jinfeng Liu , Zhenjiang Wang , Huibing Wang , Suying Lin , Jing Dong , Junshan Zhou , Suping Qin , Hui Zhan , Yongquan Xue , Dong Tian , Dan Yang , Yan Yin , He Li , Changming Geng , Jieyi Liu , Xiaolin Jiang , Yujun Wu , Wei Sun , Bingqi Yu , Yanmei Guan , Qin Wang , Bo Wei , Huirong Wang , Yan Wang , Liwen Tai , Wenchao Zhang , Weili Zhao , Xueying Wang , Guoli Li , Zhiming Ni , Fudong Guo , Lan Cen , Jun Lu , Zheng Chen , Guoming Yin , Yingchun Wang , Jiping Zheng , Zhimin Zhou , Hongquan Wang , Renlin Zou , Bin Xue , Airu Li , Jing Guo , Ying Guo , Xingguo Jiang , Xiuge Tan , Chunpeng Zhang , Bei Shao , Xiaoting Niu , Chunfeng Liu , Dongqin Chen , Ping Liang , Xia Zhang , Chunqing Zhang , Wenjie Gong , Zhichao Huang , Huihui Liu , Shoujiang You , Junying Huang , Rongfang Shi , Cuilan Wang , Ying Liu , Jinchao Wang , Guojun Wu , Zhihong Gao , Qunli Lin , Cong Xu , Huile Zheng , Xinghai Ye , Xiaoqiong Jin , Junyan Liu , Xiaoyun Cao , Yan Zhang , Jinyang Wang , Yuzhu Xu , Yan Li , Xin Ma , Qi Kong , Yanlei Hao , Baojun Qiao , Hui Yan , Zhiyong Huang , Baoqiang Chang , Jinjin Yan , Pinjun Liao , Wei Zhang , Ling Liu , Tingting Zhu , Xuehui Liu , Yongping Li , Ruifang Dong , Miao Chen , Xiaoli Ge , Hairong Wang , Lihua Dai , Jiafu Liu , Shixia Wang , Jihui Du , Aixiu Song , Yunhai Li , Jie Feng , Cheng Yu , Honglin Feng , Xiaojia Sun , Ruihong Sun , Weisong Liu , Jianfeng Liu , Xuesheng Lu , Enzhuo Chen , Wei Gao , Hui Liu , Heping Wang , Yanxia Wang , Juan Song , Dongqi Liu , Wenhui Du , Guixia Li , Cuiling Li , Yanling Liang , Xuekun Cai , Jinli Zhang , Xiaowei Tao , Pingshun An , Ranran Tang , Xu Qin , Yingling Wang , Wenjun Zhang , Rong Ma , Xiaoqiong Huang , Yonglin Liu , Yazhi Wang , Ping Fan , Hailan Yang , Lianyuan Feng , Jianxia Zhi , Jiewen Zhang , Yao Zhou , Danhong Wu , Haiyan He , Xiaohong Chen , Yongge Hou , Xiaohui Su , Liying Cui , Bin Peng , Siyuan Fan , Luis Suárez , Juan de Dios Polanco , Patricio Sotomayor , Ricardo Urzúa , Daniela Urrutia , Nathalie Conejan , Arturo Escobar , Monica Gonzalez , Danisa Vargas , Angel Constante , Erika Vásquez , Elizabeth Godoy , Christian Figueroa , Vanesa San Martin , Nataly Vidal , Madeleyn Muñoz , María Spencer , BRUNSER, ALEJANDRO , ALMEIDA TORO, JUAN MANUEL , Ignacio Acosta , Rodrigo Guerrero , Prudencio Lozano , Camila Aguayo , Jimena Pizarro , Alvaro Soto , Flor Bonilla , Pía García , Carolina Del Castillo , Marcela Grandjean , Alexis Von Johnn , Ignacio Gutierrez , Francisca Rivero , Ignacio López , Federico Silva , Marlen Pachón , José Mendoza , Alexander Pabón , Mahesh Kate , Naushad Akhtar , Gibbsdeep S. Narang , Ashish Deepak , Vikram Huded , Romnesh De Sowza , Alben Sigamani , Karthikeyan Rajendran , Anisha Vishwanath , Anusha K , Somasundaram Kumaravelu , Syed Rahamath , Sandeep Kannneganti , Dheeraj Khurana , Cheena Katoch , Taranpreet Kaur , Ummer Karadan , Anu Kuriakose , Jaison John , Mumthaz Basheer , Harsha Hemal Gunasekara , Gamlath Chandima Udeni De Silva , Peetagam Harshi Lakmali Ubeywickrama , Kavisha Chathumali Silva , Eshani Anuradha De Silva , Udaya Ranawaka , Chamila Mettananda , Yamuna Nanayakkara , Tharini Mendis , Gayathri Fernando , Ahamed Imthikab , Kandula Pieris , Saman B. Gunatilake , Pamuditha M. W. Madanayake , Shiran A. Paranavitane , Bimsara Senanayake , Vaidhehi Vishwanathan , Maathury Sivapalan , Ruwangi U. Murage , Uthpala Chandradeva , Ruey‐Tay Lin , Yao‐Hua Liu , Chih‐Lung Lin , Hsiu‐Fen Lin , Kuan‐Ting Liu , Chien‐Fu Chen , Meng‐Ni Wu , Su‐Hua Tsai , Chi‐Ching Chen , Lan‐Yi Chen , Tsong‐Hai Lee , Chien‐Hung Chang , Yeu‐Jhy Chang , Kuo‐Lun Huang , Ting‐Yu Chang , Chi‐Hung Liu , Chen‐June Seak , Yu‐Li Lin , Jia‐Yi Luo , Hsiao‐Ying Yang , Ching‐Yi Wang , Lung Chan , Chaur‐Jong Hu , Nai‐Fang Chi , Dean Wu , Yao‐Hsien Huang , Yi‐Chun Kuan , Chien‐Tai Hong , Yi‐Chun Chen , Yu Sun , Cheng‐Huai Lin , Chien‐Jung Lu , Hai‐Jui Chu , Yi‐Chia Lo , Wen‐Hui Chang , Wan‐Jung Lin , Hui‐Chen Su , Tien‐Yu Lin , Chi‐Hsuan Cho , Shu‐Lan Lu , Ya‐Fang Hsueh , Ching‐Yi Lai , David Jarrett , Claire James , Stacey Valentine , Clare Whistler , Rebecca Butler , Simone Browning , Caroline Watchurst , Renuka Erande , Emma Elliott , Krishna Patel , Maria Brezitski , Caroline Hogan , Asra Banaras , Lucinda Crook , Rashidat Ahmed , Lindsay Potter , Rosie Laird , Natasha Clarke , Alison Loosemore , J. Godber , Sara Gawned , K. A. Hamilton , Rachael Jones , Paul Guyler , Sharon Tysoe , Raji Prabakaran , Sweni Shah , Joanne Calver , Laszlo K. Sztriha , Maria Fitzpatrick , Stephanie Drysdale , John Aeron‐Thomas , Emma McKenzie , Belinda Chitando , Paul Willcoxson , Elizabeth Iveson , Peter Wanklyn , Natasha Dyer , Michael Keeling , Romina Rodriguez , Kerry Elliott , Mia Porteous , Mark O'Neill , Sheridan Orme , Carla Richardson , Janet Tomlinson , Suzanne Hawkins , Delia Bester , Carol Jeffs , Joanne Howard , Pauline Brown , Deborah Ward , Jennifer Turfrey , Leanne Raybould , Allison Bates , Sue O'Connell , Margaret O'Connor , Samantha Williams , Hedley C. A. Emsley , Alison McLoughlin , Sonia Raj , Bindu Gregary , Donna Doyle , G. M. Courtauld , C. Schofield , L. Lucas , A. Lydon , A. James , Kari Saastamoinen , Laura Howaniec , Premchand Daboo , Ali N. Ali , Emma Richards , Joanne Howe , Christine Kamara , Kathy Stocks , Ralf Lindert , Diana J. Day , Sarah Finlay , Joanne McGee , Jennifer Mitchell , Elaine Amis , Rosemary Macey , Suzanne Tauro , Lauren Henry , Sarah Cuddy , Andrew Steele , Kerry Mullen , Sarah Kirker , Murudappa Bhattad , Michael Carpenter , Prabal Datta , Ann Needle , Linda Jackson , Julie Ball , Rosie Beckitt , Nicola Chivers , Angela Bowring , Sara Eddy , Kevin Thorpe , Samantha Keenan , Alison Griffin , Stuart Maguire , Chris Patterson , Hawraman Ramadan , Ruth Bellfield , Michaela Hooley , Kelvin Stewart , Lucy Williams , Cara Gurney , Deborah Oliver , Maria Gardiner , Sarah Grayland , Mohit Bhandari , David M. Collas , Tolu Adesina , Saul Sundayi , Ruth Harvey , Emma Pope , Audrey Lam , Elaine Walker , Colin Merrill , Soma Banerjee , Kirsten Hannah Harvey , Sheila Mashate , Peter Wilding , Linda Johnson , Robert Namushi , Patricia Jacob , Sreeman Andole , Karen Dunne , Naveen Gadapa , Sam King , Sonata Siliuzaite , Sharon Dealing , Karen Attwood , Annette Woods , Banher Sandhu , Maam Mamun , Afzal Mahmood , June Jones , Abimbola Ojo , Denise Carter‐Evans , Royal Liverpool , Aravind Manoj , Glyn Fletcher , Paula Lopez , Jill Greig , Matthew Robinson , Sarah Jones , Lorinda Jones , Claire West , Helen Tench , Rachel Gascoyne , Amanda Whileman , Emily Hall , Stephanie Wright , Julie Toms , Janet Tomlinson , Duke Phiri , Sakthivel Sethuraman , Niaz Mohammed , Frances Justin , Margaret Louise Tate , Meena Chauhan , Syed I. Haider , Arumugam Nallasivan , Tim Webster , Sandra Leason , Samantha Seagrave , Peterborough City Hospital , Peter Owksu‐Agyei , Natalie Temple , Nicola Butterworth‐Cowin , Frederick Magezi , Leicester Royal Infirmary , Shagufta Khan , Claire Stephens , Amit Mistri , Aidan Murphy , Manda Lam , Paul Underwood , Catherine Thompson , Clare Buckley , Diane Wood , Sarah Board , Linda Howard , Ashraf Ahmed , Bethany Oates , Sara Leonard , Royal Bournemouth Hospital , Royal Bournemouth , Kamy Thavanesan , Michelle Dharmasiri , Sathyabama Logianathan , Catherine Ovington , Gail Hann , Chantel Cox , Craigavon Area Hospital , Southern Health , Social Care Trust , Catherine Douglas , Michael Goggin , Patricia Fearon , Sara Gilpin , Margaret O'Hagan , Pilgrim Hospital , Anne Hardwick , Kimberley Netherton , Judith Quinn , Tulu Bozkaplan , Josin Jose

Background The uptake of proven stroke treatments varies widely. We aimed to determine the association of evidence‐based processes of care for acute ischemic stroke ( AIS ) and clinical outcome of patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial), a multicenter cluster crossover trial of lying flat versus sitting up, head positioning in acute stroke. Methods and Results Use of 8 AIS processes of care were considered: reperfusion therapy in eligible patients; acute stroke unit care; antihypertensive, antiplatelet, statin, and anticoagulation for atrial fibrillation; dysphagia assessment; and physiotherapist review. Hierarchical, mixed, logistic regression models were performed to determine associations with good outcome (modified Rankin Scale scores 0–2) at 90 days, adjusted for patient and hospital variables. Among 9485 patients with AIS, implementation of all processes of care in eligible patients, or “defect‐free” care, was associated with improved outcome (odds ratio, 1.40; 95% CI, 1.18–1.65) and better survival (odds ratio, 2.23; 95% CI , 1.62–3.09). Defect‐free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0–1) (odds ratio, 1.22; 95% CI , 1.04–1.43). No hospital characteristic was independently predictive of outcome. Only 1445 (15%) of eligible patients with AIS received all processes of care, with significant regional variations in overall and individual rates. Conclusions Use of evidence‐based care is associated with improved clinical outcome in AIS . Strategies are required to address regional variation in the use of proven AIS treatments. Clinical Trial Registration URL : https://www.clinicaltrials.gov . Unique Identifier: NCT 02162017.

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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 , Hisatomi Arima , LAVADOS GERMAIN, PABLO MANUEL , BRUNSER, ALEJANDRO , Bin Peng , Liying Cui , Lily Song , Laurent Billot , Elizabeth Boaden , Maree L. Hackett , Stephane Heritier , Stephen Jan , Sandy Middleton , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , Joyce Y. Lim , Richard I. Lindley , Emma Heeley , Thompson Robinson , Octavio Pontes-Neto , Lkhamtsoo Natsagdorj , Ruey-Tay Lin , Caroline Watkins , 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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Flat-head positioning increases cerebral blood flow in anterior circulation acute ischemic stroke. A cluster randomized phase IIb trial

2018 , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , LAVADOS GERMAIN, PABLO MANUEL , MUÑOZ VENTURELLI, PAULA ANDREA , RECULE GONZALEZ, FRANCISCA , Javier Gaete , Sheila Martins , Hisatomi Arima , Craig S Anderson , BRUNSER, ALEJANDRO

Background Whether lying-flat improves blood flow in patients with acute ischemic stroke is unknown. Our aim was to investigate if lying-flat “changes” cerebral blood flow velocities assessed by transcranial Doppler in acute ischemic stroke patients. Methods In a multicenter cluster clinical trial, we randomly assigned patients within 12 h from onset of a neurological deficit due to cerebral ischemia of the anterior circulation to lying-flat or upright head positioning. The primary outcome was a change of 8 cm/s or more in mean cerebral blood flow velocities on transcranial Doppler to the middle cerebral artery at 1 and 24 h post-randomization, adjusted for imbalance in baseline variables. Secondary outcomes included serious adverse events and physical functioning at 90 days. Results Ninety-four of 304 patients screened were recruited. The primary outcome occurred in 11 (26%) of 43 patients in the lying-flat group and in 6 (12%) of 51 in the upright group at 1 h (adjusted odds ratio, 3.81; 95% CI, 1.07 to 13.54), and in 23 (53%) and 18 (36%) patients in these respective groups at 24 h (adjusted odds ratio, 3.04; 95% CI, 1.08 to 8.53). There were no between-group differences in serious adverse events, including pneumonia, heart failure or mortality, nor in functional outcome at 3 months (adjusted common odds ratio, 1.38; 95% CI 0.64 to 3.00). Conclusion The lying-flat head position was associated with a significant increase in cerebral blood flow velocities at one and 24 h within the ipsilateral hemisphere of anterior circulation acute ischemic stroke, without serious safety concerns. Clinical trial registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01706094.

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Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial

2017 , Laurent Billot , Mark Woodward , Hisatomi Arima , Maree L Hackett , MUÑOZ VENTURELLI, PAULA ANDREA , LAVADOS GERMAIN, PABLO MANUEL , BRUNSER, ALEJANDRO , Bin Peng , Liying Cui , Lily Song , Stephane Heritier , Stephen Jan , Sandy Middleton , OLAVARRIA IANISZEWSKY, VERONICA VIVIANA , Joyce Lim , Thompson Robinson , Octavio Pontes-Neto , Caroline Watkins , Craig S Anderson

Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. Objective To outline in detail the predetermined statistical analysis plan for the study. Methods All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. Results A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. Conclusions We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651

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