A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. - Full Text View

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00730964

Purpose

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

Condition	Intervention	Phase
Echocardiography	Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, USP	Phase IV

Drug Information available for: Dextrose Octafluoropropane Sodium chloride Chlorides Albumins, human

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Safety Study
Official Title:	A Post-Marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

The frequency of serious adverse reactions (SAR's) among subjects who receive Optison during contrast enhanced echocardiography in routine clinical practice. [ Time Frame: During and within 24 hours post administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The frequency of overall serious adverse events (SAE's) among subjects who receive Optison during contrast enhanced echocardiography in routine clinical practice. [ Time Frame: During and within 24 hours post administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Phase 4 Open Label	Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, 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, 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.

Arms

Assigned Interventions

Phase 4

Open Label

Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, 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, 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730964

Contacts

Contact: Veronica Reichl	609-514-6849	veronica.reichl@ge.com
Contact: Leslie Romanyshyn	609-514-6880	leslie.romananyshyn@ge.com

Locations

United States, New Jersey
GE Healthcare	Recruiting
Princeton, New Jersey, United States, 08540
Contact: Veronica Reichl 609-514-6849 veronica.reichl@ge.com

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director:

Rubin Sheng, MD

GE Healthcare

More Information

Responsible Party:	GE Healthcare ( Rubin Sheng, MD )
Study ID Numbers:	GE-191-003
Study First Received:	August 5, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00730964
Health Authority:	United States: Food and Drug Administration

Keywords provided by GE Healthcare:

Surveillance
Optison
perflutren
echocardiography
Subjects who receive Optison during enhanced echocardiography.

ClinicalTrials.gov processed this record on January 16, 2009