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The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00285506
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : May 29, 2006
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
Medical University of South Carolina

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

Condition or disease
Healthy Volunteers

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 : Observational
Estimated Enrollment : 20 participants
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.
Study Start Date : January 2006
Estimated Study Completion Date : January 2006




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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

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

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

Keywords provided by Medical University of South Carolina:
Healthy Volunteers