Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) trial: An open label dose escalation phase 1 trial followed by a randomised, double-blind, placebo-controlled phase 2 trial. - Repair of ARDS by Stromal Cell Administration (REALIST)

Belfast Health and Social Care Trust0 个研究点目标入组 78 人开始时间: 2017年11月28日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Moderate to severe 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 less than or equal to 27kPa on PEEP more than or equal to 5cmH2O)
•ii.Bilateral infiltrates on chest x-ray consistent with pulmonary oedema not explained by another pulmonary pathology
•iii.Respiratory failure not fully explained by cardiac failure or fluid overload
•2. Patient is receiving invasive mechanical ventilation
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. More than 48 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. Major trauma in the prior 5 days
•6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year
•7. WHO Class III or IV pulmonary hypertension
•8. Venous thromboembolism currently receiving anti-coagulation or within the last 3 months.
•9. Currently receiving extracorporeal life support (ECLS)
•10. Severe chronic liver disease with Child-Pugh score >12
•11. DNAR (Do Not Attempt Resuscitation) order in place
•12. Treatment withdrawal imminent within 24 hours
•13. Consent declined
•14. Prisoners
•15. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available
•16. Previously enrolled in the REALIST trial

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