NCT00451698

Brief Summary

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. We hypothesize that a single dose of erythropoietin prior to the heart bypass portion of surgery may protect the infant human heart and brain from injury. This randomized clinical trial will involve 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 16, 2013

Completed
Last Updated

November 8, 2018

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

March 22, 2007

Results QC Date

March 21, 2013

Last Update Submit

October 11, 2018

Conditions

Congenital Heart Defect

Keywords

ErythropoietinCongenital heart surgery

Outcome Measures

Primary Outcomes (3)

  • Biochemical Markers of Heart Damage

    Troponin I levels (ng/ml) measured at 4 time points

    4 postoperative time points up to 48 hours

  • Biochemical Markers of Neuron Damage

    4 postoperative time points

  • Echocardiographic Assessment of Heart Function

    24 hours postop

Secondary Outcomes (2)

  • Inotropic Support

    24 and 48 hours post operative

  • Length of Hospitalization

    At hospital discharge, up to 30 days

Study Arms (2)

3

PLACEBO COMPARATOR

acyanotic placebo

Drug: acyanotic placebo

4

EXPERIMENTAL

acyanotic erythropoietin

Drug: acyanotic erythropoietin

Interventions

acyanotic erythropoietinDRUG

Single dose IV push

4
acyanotic placeboDRUG

Single dose IV push

3

Eligibility Criteria

Age6 Weeks - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6 weeks to 18 years
  • Requiring open heart surgery for congenital heart defect -Parents able to speak English and document informed consent -

You may not qualify if:

  • Received erythropoietin within past 30 days
  • Previous adverse reaction to erythropoietin or to albumin
  • History of neurological disorder -Laboratory evidence of kidney or liver dysfunction -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Shi Y, Rafiee P, Su J, Pritchard KA Jr, Tweddell JS, Baker JE. Acute cardioprotective effects of erythropoietin in infant rabbits are mediated by activation of protein kinases and potassium channels. Basic Res Cardiol. 2004 May;99(3):173-82. doi: 10.1007/s00395-004-0455-x. Epub 2004 Jan 29.

    PMID: 15088102BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Analysis was limited to descriptive statistics due to low enrollment and study closure. The number of participants fell far short of study goals and the study was terminated prematurely due to inadequate enrollment.

Results Point of Contact

Title
Dr. Steven Zangwill
Organization
Medical College of Wisconsin
szangwill@chw.org
414-266-2380

Study Officials

  • Steve Zangwill, MD

    Children's Hospital and Health System Foundation, Wisconsin

    PRINCIPAL INVESTIGATOR

  • John Baker, PhD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 8, 2018

Results First Posted

July 16, 2013

Record last verified: 2018-10

Locations

US(1)