Erythropoietin and Pediatric Cardiac Surgery (EPO)

This study has been terminated.
(Inadequate patient enrollment)
Sponsor:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Steven Zangwill, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00451698
First received: March 22, 2007
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Congenital Heart Defect
Drug: acyanotic erythropoietin
Drug: acyanotic placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Erythropoietin and Pediatric Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Biochemical Markers of Heart Damage [ Time Frame: 4 postoperative time points ] [ Designated as safety issue: No ]
    Troponin I levels (ng/ml) measured at 4 time points

  • Biochemical Markers of Neuron Damage [ Time Frame: 4 postoperative time points ] [ Designated as safety issue: No ]
  • Echocardiographic Assessment of Heart Function [ Time Frame: 24 hours postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inotropic Support [ Time Frame: 24 and 48 hours post operative ] [ Designated as safety issue: No ]
  • Length of Hospitalization [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: October 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 3
acyanotic placebo
Drug: acyanotic placebo
Single dose IV push
Experimental: 4
acyanotic erythropoietin
Drug: acyanotic erythropoietin
Single dose IV push

Detailed Description:

Lack of bloodflow to the heart and brain when the heart is stopped during heart surgery can cause damage to those organs. A medicine already used in humans, erythropoietin, may protect the heart and brain of children born with heart defects during their surgical repair. In a rabbit model, erythropoietin did protect the hearts. 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.

For this randomized control trial, 120 children, age 6 weeks to 18 years, requiring heart bypass surgery for congenital heart defects, will be divided into four groups. Two groups will be children whose usual blood oxygen level is low because of their heart defect; the other two will be children with normal blood oxygen levels. Each child will be randomized to receive either erythropoietin or placebo 15 minutes prior to stopping the heart during their surgery.

Erythropoietin's protective function will be measured after surgery by: (1) amount of medication required to support heart function, (2) how well the heart pumps blood as seen by echocardiogram, (3) levels of chemicals produced by the body when heart or brain tissue injury occurs, (4) urine output and oxygen levels (5) time on ventilator support (6) ICU stay and (7) hospital stay. Heart tissue will be collected during surgery to determine how erythropoietin protects heart cells.

Statistical tests including ANOVA will test for similarities and differences among the groups on the measures of protection from injury.

Note - the study design was edited after the FDA released a warning about the use of erythropoietin. Only acyanotic patients were recruited therefore only 2 study groups are included.

  Eligibility

Ages Eligible for Study:   6 Weeks to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451698

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Steve Zangwill, MD Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: John Baker, PhD Medical College of Wisconsin
  More Information

Publications:
Responsible Party: Steven Zangwill, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00451698     History of Changes
Other Study ID Numbers: CHW 04/161
Study First Received: March 22, 2007
Results First Received: March 21, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical College of Wisconsin:
Erythropoietin
Congenital heart surgery

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014