PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. A randomised, open, phase III, clinical trial with blinded outcome assessment

niversity Medical Center Utrecht0 个研究点目标入组 1,493 人开始时间: 2015年9月22日最近更新: 2024年1月8日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30246150 protocol 2022 Abstract results in https://doi.org/10.1177/23969873221094907 (added 10/10/2023) 2017 Abstract results in https://doi.org/10.1177/2396987317706897 (added 10/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38074444/ (added 11/12/2023)

•1. Clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage (confirmed with CT or MRI scan)
•2. Score on the National Institutes of Health Stroke Scale58 (NIHSS) =6, indicating moderately severe to severe stroke
•3. Aged 66 years or older
•4. Possibility to start trial treatment within 12 h of symptom onset

•All participants:
•1. Active infection requiring antibiotic treatment, as judged by the treating physician;
•2. Pre-stroke score on the modified Rankin Scale =4
•3. Death appearing imminent at the time of assessment.
•For the ceftriaxone arm:
•1. Known hypersensitivity to beta-lactam antibiotics
•For the paracetamol arm:
•1. Known hypersensitivity to paracetamol or any of the excipients
•2. Known severe hepatic insufficiency
•3. Chronic alcoholism
•For the metoclopramide arm:
•1. Hypersensitivity to the metoclopramide or to any of the excipients
•2. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk
•3. Confirmed or suspected pheochromocytoma
•4. History of neuroleptic or metoclopramide-induced tardive dyskinesia
•5. Epilepsy
•6. Parkinson's disease
•7. Use of levodopa or dopaminergic agonists
•8. Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency

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