CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,039 enrolled
Drug / intervention
Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)drug
Likely dose
Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00730964
NCT00730964Phase 4Completed
CompareCT.gov

A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

GE Healthcare·interventional·Posted Aug 8, 2008·Updated Jun 12, 2012

In Brief

A Phase 4 clinical trial evaluating Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) for Echocardiography. Completed, enrolled 1,039 participants across 1 site.

Detailed Summary

This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEchocardiography
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartMay 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.9 years ago

Interventions

Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)drug

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.