Post-market Safety Reassessment of Ulinastatin for Injection
Study Details
Study Description
Brief Summary
-
Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
-
Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin.
-
Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| general department Patients using ulinastatin in department beyond ICU would be labelled as general department group. |
Drug: ulinastatin
We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.
Other Names:
|
| ICU Patients using ulinastatin in ICU would be labelled as ICU group. |
Drug: ulinastatin
We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [participants will be followed for the duration of using ulinastatin, an expected average of 7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with ulinastatin treated
Exclusion Criteria:
- Not applicable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | China | 510115 |
Sponsors and Collaborators
- Techpool Bio-Pharma Co., Ltd.
- Center for ADR Monitoring of Guangdong
Investigators
- Principal Investigator: Jin Li, doctor, Center for Adverse Drug Reaction Monitoring of Guangdong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 002/20140709