Therapeutic Iloprost for the treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial): a prospective, randomized, multicenter phase II study - Thllo

niversity Tuebingen0 sites150 target enrollmentNovember 29, 2018

DrugsVentavis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Tuebingen
Enrollment: 150
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 29, 2018

End Date

November 25, 2022

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Tuebingen

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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\).