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| Name | Class |
|---|---|
| Center for ADR Monitoring of Guangdong | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| general department | Patients using ulinastatin in department beyond ICU would be labelled as general department group. |
| |
| ICU | Patients using ulinastatin in ICU would be labelled as ICU group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ulinastatin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients with ulinastatin treated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mingjuan Hua, Master | Contact | +86 020 38972288 | huamj@techpool.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, doctor | Center for Adverse Drug Reaction Monitoring of Guangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510115 | China |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
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