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
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 April 20, 2014