Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to
conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02895191
Ages eligible for Study
18 Years to 100 Years
Genders eligible for Study
Accepts Healthy Volunteers
Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
Male or Female patients ≥18 years of age;
ARDS defined with using 2012 Berlin Criteria;
ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg < PaO2/FiO2 < 250mmhg with CPAP/PEEP≥5 cmH2O;
Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
Patients with artificial organs replacement therapy for liver or kidney；
Glasgow Coma Scale (GCS)≤8；
Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
ARDS caused by burning, drowning, poisoning;
Presence of severe chronic liver diseases (Child-Pugh score 12-15)，or severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen;
Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent
(within 7days or anytime during present hospitalization) cardiopulmonary arrest;
Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs;
No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol;
Lung transplant patients;
Patients with malignancy, expected to live no longer than 6 months;
Pregnant or breast-feeding;
Patients who have participated in any clinical study within 3 months prior to the screening;
Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.
All locations for NCT02895191
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing, China, 100029
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China, 570311
Huadong Hospital,Fudan University
Shanghai, Shanghai, China, 200040
Shanghai Sixth People's Hospital
Shanghai, Shanghia, China, 200233
West China Hospital
Chengdu, Sichuan, China, 610041
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
Hangzhou, Zhejiang, China, 310030
Lishui City People's Hospital
Lishui, Zhejiang, China, 323000
View full eligibility
Tris trial is registered with FDA with number: NCT02895191. The sponsor of the trial is Techpool Bio-Pharma Co., Ltd. and it is looking for 60 volunteers for the current phase.
Official trial title: A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
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