EUCTR2016-003168-37-DE进行中（未招募）1 期
Therapeutic Iloprost for the treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial): a prospective, randomized, multicenter phase II study - Thllo
niversity Tuebingen0 个研究点目标入组 150 人开始时间: 2018年11月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.PaO2/ FiO2 = 300
- •2.Bilateral opacities on frontal chest radiograph, and
- •3.requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- •4.no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
- •5.The term acute onset” is defined as following: the duration of the hypoxemia criterion (#i) and the chest radiograph criterion (#ii) must be = 28 days at the time of randomization. Patients must be enrolled within 48 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation.
- •6.Subject’s Age = 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1.Subject’s Age < 18 years
- •2.More than 7 days since initiation of mechanical ventilation
- •3.more than 48 hours since onset of ARDS
- •4.Patient, surrogate or physician not committed to full intensive care support.
- •5.Positive Pregnancy test at the time of screening.
- •6.Contraindications for Iloprost: Conditions where the effects of Iloprost on platelets might increase the risk of hemorrhage (e.g. active peptic ulcers, trauma, intracranial hemorrhage), severe coronary heart disease, myocardial infarction (within the last 6 months), decompensated heart failure, severe arrhythmias, unstable angina pectoris, pulmonary arterial hypertension caused by occlusion of pulmonary veins, cerebrovascular events (e.g. transient ischemic attack, stroke) within the last 3 months, congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension, patients taking Direct Thrombin Inhibitors within previous 24h before study randomization.
- •7.Patients having NO Therapy within the previous 24h before study randomization
- •7.8.Patients who received Iloprost treatment for any indication within 48 hours prior to the enrolment into the clinical trial
- •8.9.Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
- •9.10.Subject (male or female) is not willing to use highly effective methods of contraception according to the Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment and for 28 days (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasoing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
研究者
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