NCT02527811

Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

A Randomized, Controlled Trial Evaluating Efficacy of Perioperative Organ Protection as Well as Safety of Ulinastatin Use in Pediatric Patients Undergoing Open Heart Surgery Through CPB to Treat Complex Congenital Heart Diseases

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Techpool Bio-Pharma Co., Ltd. · Industry
• Sex: All
• Age: 30 Days – 4 Years
• Healthy volunteers: Not accepted

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

Detailed description

Pediatric patients diagnosed with Complex Congenital Heart Disease ready to accept scheduled open-heart surgery under cardiopulmonary bypass (CPB). This study uses randomized (centralized randomization) \& controlled design with open label. Eligible subjects will be randomized to receive either study drug (Ulinastatin) or conventional treatment.

Conditions

• Congenital Heart Diseases

Interventions

Type	Name	Description
DRUG	Ulinastatin	Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-08-19
• Last updated: 2018-01-17

Locations

5 sites across 1 country: China