NCT02802592

EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery-CABG
• Cardiac Valve Replacement

Interventions

Type	Name	Description
DRUG	Epogen	1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
DRUG	Normal Saline	1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-06-15
• Completion: 2017-02-27
• First posted: 2016-06-16
• Last updated: 2019-02-26
• Results posted: 2017-09-14

Locations

1 site across 1 country: United States