NCT02802592

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

September 14, 2017

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

June 3, 2016

Results QC Date

August 17, 2017

Last Update Submit

February 4, 2019

Conditions

Cardiac Surgery-CABGCardiac Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period

    Start of surgery to 96 hours post op

Secondary Outcomes (3)

  • Length of Stay (# of Total Days Hospitalized)

    up to one year from date of surgery

  • Overall Hospitalization Cost

    up to one year from date of surgery

  • Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey

    assessed at 1-week, 1-month, and 3-months from date of surgery

Study Arms (2)

Epogen

ACTIVE COMPARATOR

1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr

Drug: Epogen

Normal Saline

PLACEBO COMPARATOR

250 ml normal saline infused over 1 hr

Drug: Normal Saline

Interventions

EpogenDRUG

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Also known as: EPOETIN, Procrit
Epogen
Normal SalineDRUG

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Also known as: Placebo
Normal Saline

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be male or female and 18 years of age or older, but less than 65 years of age
  • Be willing to performed written informed consent prior to study initiation
  • Be willing and able to comply with the protocol for study duration
  • Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.

You may not qualify if:

  • Over the age of 64 years
  • Patients who receive allogeneic transfusion 60 days prior to surgery
  • Hgb \> 15g/dl
  • Patients who are pregnant or currently lactating
  • Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.
  • End-stage renal disease requiring renal replacement therapy or dialysis
  • Hepatic dysfunction (defined as total bilirubin value \> 1.5 mg/dl)
  • Off-pump (no CPB) cardiac surgery
  • Emergency surgical procedure
  • Inability to receive blood products
  • Endocarditis as defined my Modified Duke Criteria
  • Any congenital coagulation disorder
  • Chronic anemia (defined as preoperative Hgb concentration \< 10 g/dl)
  • Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)
  • Not a surgical candidate due to high risk of morbidity or mortality
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Interventions

Epoetin AlfaErythropoietinSaline Solution

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Kenneth Horvath
Organization
Johns Hopkins University School of Medicine
301-896-3100

Study Officials

  • Keith A. Horvath, MD

    Johns Hopkins Community Physicians

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 16, 2016

Study Start

May 1, 2015

Primary Completion

June 15, 2016

Study Completion

February 27, 2017

Last Updated

February 26, 2019

Results First Posted

September 14, 2017

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)