Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborator: Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
• Treatments: Iloprost; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• CHD children who have associated PH risk factors and have accepted biventricular repair

• Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)

Exclusion Criteria:

• severe mitral stenosis

• obstructive drainage of pulmonary veins

• platelet count < 50,000,000,000/L & obvious bleeding