A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. (OSSAR)
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|ClinicalTrials.gov Identifier: NCT00730964|
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : June 12, 2012
Last Update Posted : June 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Echocardiography||Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1039 participants|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730964
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Rubin Sheng, MD||GE Healthcare|