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

niversity Medical Center Utrecht0 个研究点目标入组 3,800 人开始时间: 2015年11月17日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•1. A clinical diagnosis of acute ischaemic stroke or intracerebral haemorrhage, confirmed with CT or MRI scan. A normal CT scan is considered compatible with ischaemic stroke;
•2. A score on the National Institutes of Health Stroke Scale (NIHSS) = 6, indicating moderately severe to severe stroke;
•3. Age 66 years or older;
•4. The possibility to start treatment within 12 hours of symptom onset;
•5. Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3800

•1. Active infection requiring antibiotic treatment, as judged by the treating physician;
•2. Clinical indication for one or more of the drugs tested in this patient;
•3. Pre-stroke score on the mRS =4;
•4. Death appearing imminent at the time of assessment.
•In addition, patients will be excluded from participation in the trial treatment arms for any of the following reasons:
•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.

发起方