A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. (OSSAR)
This study has been completed.
Sponsor:
GE Healthcare
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
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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, United States Pharmacopeia (USP) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 1039 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Phase 4
Open Label
|
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:
|
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 More Information
No publications provided
| Responsible Party: | GE Healthcare |
| ClinicalTrials.gov Identifier: | NCT00730964 History of Changes |
| Other Study ID Numbers: | GE-191-003 |
| Study First Received: | August 5, 2008 |
| Results First Received: | April 5, 2012 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GE Healthcare:
|
Surveillance Optison Perflutren Echocardiography Subjects receive Optison during enhanced echocardiography |
ClinicalTrials.gov processed this record on May 19, 2013