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
  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:
  • Optison
  • Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Rubin Sheng, MD GE Healthcare
  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 July 22, 2014