A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. (OSSAR)
|Echocardiography||Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice|
- 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 ]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 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 ]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.
|Study Start Date:||May 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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 Name: Optison
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730964
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Rubin Sheng, MD||GE Healthcare|