EUCTR2010-024377-40-AT
Active, not recruiting
Phase 1
A randomized phase II pilot - trial, examining the safety, pharmacokinetics, pharmacodynamics, and clinical efficacy of escalating doses of alteplase in patients with acute lung injury / acute respiratory distress syndrome / severe pneumonia - TPA-ALI
Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie0 sitesMay 23, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects fulfilling the criteria for ALI/ARDS/severe pneumonia and need for a ventilator
- •Negative urine pregnancy test
- •acute stage ALI/ARDS/severe pneumonia
- •Are the trial subjects under 18? no
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 30
Exclusion Criteria
- •Known or suspected allergy to trial product or related products
- •History of heparin induced thrombocytopenia type II
- •Treatment with an investigational drug within three weeks prior to this trial
- •Pregnancy (pregnancy will be ruled out in women of childbearing age by urine test)
- •Severe bleeding disorder (acute or within last 6 months)
- •Known bleeding diathesis
- •Patients on oral anticoagulant therapy at randomization
- •Overt or recent severe or life\-threatening bleeding
- •Present or known or suspected intracranial bleeding
- •Suspicion of subarachnoid hemorrhage or history of aneurismal subarachnoid hemorrhage
Outcomes
Primary Outcomes
Not specified
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