NCT00730964

A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.

A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,039 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Conditions

• Echocardiography

Interventions

Type	Name	Description
DRUG	Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)	The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) . The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-08-08
• Last updated: 2012-06-12
• Results posted: 2012-06-12

Locations

1 site across 1 country: United States