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 个研究点开始时间: 2011年5月23日最近更新: 2017年5月22日

试验速览

暂无简介。

•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

•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
•History of intracranial neoplasm, aneurysm, intracranial or intraspinal surgery
•Recent (less than 10 days) traumatic CPR, obstetric delivery;
•Severe uncontrolled arterial hypertension
•Bacterial endocarditis, pericarditis
•Acute pancreatitis
•Evidence of ulcera disease gastrointestinal tract within 3 months, esophageal varices, arterial aneurysm, arteriovenous malformations;
•Neoplasm with high bleeding risk
•Severe liver disease including liver failure, cirrhosis, portal hypertension, acute hepatitis;
•Major trauma or major surgery within 3 months
•Patients at the age of over 80 and under 18 years
•Hemorrhagic stroke or history of stroke of unknown origin;
•Known ischemic stroke or transient ischemic attack in the last 6 months
•Patients on drotrecogin alpha therapy
•Aspirin therapy >650mg q day

发起方

Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie