The Effect of Contrast Media on Erythrocytes in Healthy Volunteers
|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.|
|ClinicalTrials.gov Identifier: NCT00285506|
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : May 29, 2006
|Condition or disease|
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|
|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|
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
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||U. Joseph Schoepf, MD||Medical University of South Carolina|