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Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

NCT02527811 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2018-01-17

No results posted yet for this study

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

Conditions

  • Congenital Heart Diseases

Interventions

DRUG

Ulinastatin

Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative

Sponsors & Collaborators

  • Shanghai Children's Medical Center

    collaborator OTHER

  • Guangzhou Women and Children's Medical Center

    collaborator OTHER

  • Guangzhou General Hospital of Guangzhou Military Command

    collaborator OTHER

  • Nanjing Children's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Techpool Bio-Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Wang, MD · Shanghai Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527811 on ClinicalTrials.gov