Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210626
Status:
TERMINATED
Last Update Posted:
2014-04-21
First Post:
2005-09-13
Brief Title:
Assess Functional Outcomes in Anemic Critically Ill Trauma Patients When Taking Epoetin Alfa
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Assess the Effect of Recombinant Human Erythropoietin Epoetin Alfa PROCRIT on Functional Outcomes in Anemic Critically Ill Trauma Subjects
Status:
TERMINATED
Status Verified Date:
2014-04
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 trial is to evaluate the physical function outcomes in anemic critically ill trauma subjects treated with epoetin alfa PROCRIT compared to placebo
Detailed Description:
The overall study design is based on the assumption that the maximum increase in red blood cells and their effect often does not occur while a subject is in the ICU and acutely ill The study hypothesis is that a higher hemoglobin red blood cells carries more oxygen and delivers oxygen to the tissues This should increase the ability of the injured subject to tolerate the physical exertion involved in the recuperative process and thus recover earlier than someone with a lower hemoglobin
One milliliter of a colorless liquid is injected under the subjects skin weekly during their hospital stay and weekly for up to an additional 12 weeks after hospital discharge
One milliliter of a colorless liquid is injected under the subjects skin weekly during their hospital stay and weekly for up to an additional 12 weeks after hospital discharge
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 |
|---|---|---|---|
| PR04-15-001 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |
| LTTO | OTHER | None | None |
| Long Term Treatment Outcomes | OTHER | None | None |