- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00285506
The Effect of Contrast Media on Erythrocytes in Healthy Volunteers
The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.
Study Overview
Status
Conditions
Detailed Description
The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar agents.
In addition, the effect of the injection of contrast media at higher temperatures (i.e. > room or body temperature), which may be beneficial for the rapid injection of more viscous contrast media at multi detector-row CT angiography, has never been evaluated.
We intend to assess the hypothesis, that iso-osmolar contrast media (i.e. Visipaque) exerts less effect on erythrocyte morphology and function as compared to low-osmolar agents.
In addition, we intend to identify the upper temperature limit, at which contrast media can be injected, without affecting erythrocyte integrity.
Subjects will have up tp 400 mLs (approximately 26 tablespoons) of blood drawn. The blood will be kept at body temperature in a petri dish or similar container and exposed to contrast media (dye).
Study Type
Enrollment
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects must be at least 18 years old
- Subjects must be at least 110lbs and
Exclusion Criteria:
- Subjects may not be pregnant
- Subjects must not possess any medical conditions that would preclude them from participating
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Other
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: U. Joseph Schoepf, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HR 15813
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