drugset / Trial / NCT02527811
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
Phase 4
Unknown
450 enrolled
Techpool Bio-Pharma Co., Ltd.
Children's Hospital of Fudan University · collabGuangzhou General Hospital of Guangzhou Military Command · collabGuangzhou Women and Children's Medical Center · collabNanjing Children's Hospital · collabShanghai Children's Medical Center · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay \& cost
Timeline
- Start
- 2015-04
- Primary completion
- 2018-06
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ulinastatin | Protein / enzyme biologic | 30000 iu/kg | Intravenous |