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Clinical Trial Summary

This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.


Clinical Trial Description

Primary objectives:

1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.

2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.

Secondary objectives:

1. To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.

2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01598441
Study type Interventional
Source Shanghai Jiao Tong University School of Medicine
Contact
Status Completed
Phase Phase 3
Start date June 2012
Completion date November 2016

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