The Effect of Contrast Media on Erythrocytes in Healthy Volunteers

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

GE Healthcare

Registry information

Official study title

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

Important dates

Study start: 2006
Study completion: 2006
First posted: Feb 2, 2006
Registry last updated: May 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed