Post-market Safety Reassessment of Ulinastatin for Injection

Techpool Bio-Pharma

Status: Unknown

Conditions: Adverse Reaction to Drug

Treatments: Drug: ulinastatin

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02520570

002/20140709

Details and patient eligibility

About

1. Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc )
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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ulinastatin treated

Exclusion criteria

• Not applicable

Trial design

10,000 participants in 2 patient groups

general department

Description:

Patients using ulinastatin in department beyond ICU would be labelled as general department group.

Treatment:

Drug: ulinastatin

ICU

Description:

Patients using ulinastatin in ICU would be labelled as ICU group.

Treatment:

Drug: ulinastatin