Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT02802592
Status:
TERMINATED
Last Update Posted:
2019-02-26
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPORT
Brief Summary:
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Detailed Description:
The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age \< 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.
Study Oversight
Has Oversight DMC:
False
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?: