Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368238
Status:
COMPLETED
Last Update Posted:
2006-08-24
First Post:
2006-08-23
Brief Title:
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2006-08
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 this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia Platelets are small cells in the blood that help clot blood in case of injury Platelets also sometimes form blood clots in blood vessels that may cause heart attacks This study is trying to determine whether erythropoietin increases the clotting action of platelets Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks
Detailed Description:
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials more information on the effects of short-term rHuEpo on platelet function are needed Accordingly the current proposal aims to determine the effects of 3 doses of rHuEpo 100Ukg 200Ukg and 400Ukg daily for 3 days on platelet function and other safety measures in healthy subjects
Specific Aim To determine the effects of three ascending doses of rHuEpo vs placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel
Hypotheses to be tested 1 1 Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo 2 Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo
Specific Aim To determine the effects of three ascending doses of rHuEpo vs placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel
Hypotheses to be tested 1 1 Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo 2 Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AHA 0555844T | None | None | None |