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

Echocardiography Clinical Trial

— OSSAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730964
• Other study ID #: GE-191-003
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2008
• Last updated: May 9, 2012
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: May 2012
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is over 18 years old.

• The subject has been scheduled for an Optison-enhanced echocardiography exam.

• The subject has provided signed and dated informed consent.

Exclusion Criteria:

• Known hypersensitivity to perflutren, blood, blood products or albumin.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Echocardiography

Intervention

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.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.	A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.	Within 24 hours post contrast administration	Yes
Secondary	The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.	The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.	Within 24 hours post contrast administration	Yes