Trial Outcomes & Findings for EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT) (NCT NCT02802592)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Start of surgery to 96 hours post op

Results posted on

2019-02-26

Participant Flow

This study was terminated due to loss of funding and those participants enrolled were not un-blinded to the study team members.

Participant milestones

Participant milestones
Measure	All Participants 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Overall Study Study terminated due to loss of funding	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=4 Participants 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Start of surgery to 96 hours post op

Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to one year from date of surgery

Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to one year from date of surgery

Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Participants n=4 participants at risk 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Blood and lymphatic system disorders Cerebrovascular Accident	0.00% 0/4

Other adverse events

Other adverse events
Measure	All Participants n=4 participants at risk 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm OR 250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Blood and lymphatic system disorders Mediastinal bleeding	25.0% 1/4 • Number of events 1
Cardiac disorders Complete Heart Block	25.0% 1/4 • Number of events 1
Blood and lymphatic system disorders Pleural Effusion	25.0% 1/4 • Number of events 1
Cardiac disorders Acute Congestive Heart Failure	25.0% 1/4 • Number of events 1
Blood and lymphatic system disorders Ankle Edema (Bilateral)	25.0% 1/4 • Number of events 1
Cardiac disorders Atrial Flutter	25.0% 1/4 • Number of events 1

Additional Information

Dr. Kenneth Horvath

Johns Hopkins University School of Medicine

Phone: 301-896-3100

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place