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Clinical Trials/NCT00285506
NCT00285506CompletedNot Applicable

The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.

Medical University of South Carolina1 site in 1 country20 target enrollmentStarted: January 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1

Study Overview

Brief Summary

The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)

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 Design

Study Type
Observational
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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