ASpirin as a Treatment for ARDS (STAR) trial: a randomised, double-blind, allocation concealed, placebo-controlled phase 2 trial. - ASpirin as Treatment for ARDS (STAR)

Belfast Health and Social Care Trust0 个研究点目标入组 49 人开始时间: 2015年3月4日最近更新: 2020年8月3日

适应症

试验速览

暂无简介。

•1.Patients receiving invasive mechanical ventilation
•2.ARDS as defined by the Berlin definition
•a)Onset within 1 week of identified insult
•b)Within the same 24 hour time period
•i.Hypoxic respiratory failure (PaO2/ FiO2 ratio = 40kPa on PEEP = 5 cmH20)
•ii.Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology
•iii.No evidence of heart failure or volume overload
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 28

•1.More than 72 hours from the onset of ARDS
•2.Age < 16 years
•3.Patient is known to be pregnant
•4.Participation in a clinical trial of an investigational medicinal product within 30 days
•5.Current treatment with aspirin or within the past 4 weeks
•6.Platelet count < 50 x 109/l
•7.Haemophilia or other haemorrhagic disorder or concurrent therapeutic anticoagulant therapy
•8.History of aspirin sensitive asthma or nasal polyps associated with asthma
•9.Active peptic ulcer disease or endoscopically proven history of peptic ulceration
•10.Traumatic brain injury
•11.Severe chronic liver disease with Child-Pugh score > 12
•12.Active or recent bleeding (in previous 3 months)
•13.Known hypersensitivity or previous adverse reaction to aspirin
•14.Physician decision that aspirin is required for proven indication
•15.Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction.
•16.Treatment withdrawal imminent within 24 hours
•17.Consent declined.

发起方