Ignite Creation Date:
2025-12-18 @ 9:45 AM
Ignite Modification Date:
2025-12-18 @ 9:45 AM
Study NCT ID:
NCT00691613
Status:
None
Last Update Posted:
2010-03-12 00:00:00
First Post:
2008-06-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model
Sponsor:
None
Organization:
Study Overview
Official Title:
Infusion of a Single Dose of Erythropoietin to Prevent Injury in an Ischemia Reperfusion Forearm Model - A Randomised Cross-over Study to Evaluate if Infusion of a Single Dose of EPO Protects Against Ischemia-reperfusion Injury in Man
Status:
None
Status Verified Date:
2010-03
Last Known Status:
NOT_YET_RECRUITING
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:
IPIIR
Brief Summary:
Rationale:
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Objective:
Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?
Study design:
A double blinded randomised cross-over study.
Study population:
12 Healthy male volunteers, between 18 and 40 years old.
Intervention:
All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six week wash-out period is obtained in order to avoid interference of both treatments.
Main study parameters/endpoints:
The percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.
The investigators hypothesize that EPO protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-A5 model.
Objective:
Does infusion of a single dose of Epoetin Alfa, a short-acting EPO, protect against apoptosis in man after acute ischemia?
Study design:
A double blinded randomised cross-over study.
Study population:
12 Healthy male volunteers, between 18 and 40 years old.
Intervention:
All 12 volunteers will receive a single dose of EPO and placebo in a randomized order. A six week wash-out period is obtained in order to avoid interference of both treatments.
Main study parameters/endpoints:
The percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.
Detailed Description:
None
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?: