NCT00939978

Brief Summary

The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 7, 2010

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

July 14, 2009

Last Update Submit

October 6, 2010

Conditions

Cardiac Surgery

Study Arms (2)

Venoferrum

ACTIVE COMPARATOR
Drug: rhEPO

saline

PLACEBO COMPARATOR
Drug: rhEPO

Interventions

rhEPODRUG

recombinant human erythropoietin(rhEPO)

Venoferrumsaline

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20)

You may not qualify if:

  • Uncontrolled hypertension(diastolic blood pressure(DBP)\>100 mmHg), Hct \> 45%, Plt. count)\>450,000
  • There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis.
  • No pregnancy, acute hyper parathyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

October 7, 2010

Record last verified: 2010-10

Locations

KR(1)