Effect of Preoperative Recombinant Human Erythropoietin o... | NCT00939978

Studies
Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery

NCT00939978

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Oct 7, 2010Estimated

Enrollment

74Actual

Phase

Not Applicable

Conditions

Cardiac Surgery

Interventions

rhEPO

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jul 14, 2009

First Submission Date that Met QC Criteria

Jul 14, 2009

First Posted Date

Jul 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2010

Last Update Posted Date

Oct 7, 2010Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Venoferrum	Active Comparator		Drug: rhEPO
saline	Placebo Comparator		Drug: rhEPO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rhEPO	Drug	recombinant human erythropoietin(rhEPO)	Venoferrum saline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance hospital		Seoul		120-752	South Korea