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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00730964
First received: August 5, 2008
Last updated: May 9, 2012
Last verified: May 2012

August 5, 2008
May 9, 2012
May 2008
October 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: Within 24 hours post contrast administration ] [ Designated as safety issue: Yes ]
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.
The frequency of serious adverse reactions (SAR's) among subjects who receive Optison during contrast enhanced electrocardiography in routine clinical practice. [ Time Frame: During and within 30 minutes post administration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00730964 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Within 24 hours post contrast administration ] [ Designated as safety issue: Yes ]
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.
The frequency of overall serious adverse events (SAE's) among subjects who receive Optison during contrast enhanced electrocardiography in routine clinical practice. [ Time Frame: During and within 30 minutes post administration ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Echocardiography
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.

Other Names:
  • Optison
  • Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Phase 4
Open Label
Intervention: Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1039
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730964
GE-191-003
Yes
GE Healthcare
GE Healthcare
Not Provided
Study Director: Rubin Sheng, MD GE Healthcare
GE Healthcare
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP