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The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285506
First Posted: February 2, 2006
Last Update Posted: May 29, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GE Healthcare
Information provided by:
Medical University of South Carolina
  Purpose
The purpose of the study is to test the effect that contrast media (dye) has on cellular integrity (structure)

Condition
Healthy Volunteers

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.

Further study details as provided by Medical University of South Carolina:

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Study Completion Date: January 2006
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285506


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
GE Healthcare
Investigators
Principal Investigator: U. Joseph Schoepf, MD Medical University of South Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00285506     History of Changes
Other Study ID Numbers: HR 15813
First Submitted: January 31, 2006
First Posted: February 2, 2006
Last Update Posted: May 29, 2006
Last Verified: January 2006

Keywords provided by Medical University of South Carolina:
Healthy Volunteers