Post-market Safety Reassessment of Ulinastatin for Injection
NCT ID: NCT02520570
Last Updated: 2018-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10000 participants
OBSERVATIONAL
2014-08-31
2018-08-31
Brief Summary
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2. 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.
3. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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general department
Patients using ulinastatin in department beyond ICU would be labelled as general department group.
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.
ICU
Patients using ulinastatin in ICU would be labelled as ICU group.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Center for ADR Monitoring of Guangdong
UNKNOWN
Techpool Bio-Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Li, doctor
Role: PRINCIPAL_INVESTIGATOR
Center for Adverse Drug Reaction Monitoring of Guangdong
Locations
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Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Hua Lin
Role: primary
Other Identifiers
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002/20140709
Identifier Type: -
Identifier Source: org_study_id
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