Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285506
Status:
COMPLETED
Last Update Posted:
2006-05-29
First Post:
2006-01-31
Brief Title:
The Effect of Contrast Media on Erythrocytes in Healthy Volunteers
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to test the effect that contrast media dye has on cellular integrity structure
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 ie 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 ie 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
In addition the effect of the injection of contrast media at higher temperatures ie 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None