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The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

NCT ID: NCT00285506

Last Updated: 2006-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-01-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Healthy Volunteers

Keywords

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Healthy Volunteers

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Principal Investigators

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U. Joseph Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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HR 15813

Identifier Type: -

Identifier Source: org_study_id