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Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00513240
Recruitment Status : Active, not recruiting
First Posted : August 8, 2007
Results First Posted : May 19, 2014
Last Update Posted : January 6, 2017
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Dana Foundation
Texas Children's Hospital
Information provided by (Responsible Party):
Dean Andropoulos, Baylor College of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Congenital Heart Disease
Hypoplastic Left Heart Syndrome
Transposition of the Great Arteries
Aortic Arch Hypoplasia or Interruption
Interventions: Drug: Erythropoetin
Drug: Normal saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from September 2006 to February 2011 in the Texas Children's Hospital Heart Center NICU and CVICU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
357 assessed for eligibility; 253 did not meet inclusion criteria. 42 subjects that eligible but consent not obtained (24 declined, 2 enrolled in another study, 16 investigator not available for consent or patient lived too far away). 62 consented, enrolled, received 1 dose EPO, but intended surgery not done on 3 subjects (no CPB); leaving 59.

Reporting Groups
  Description
EPO Group

Patients randomized to receive the 3 doses of erythropoetin.

Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2

Control Group.

Patients randomized to receive 3 doses of normal saline control.

Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.


Participant Flow:   Overall Study
    EPO Group   Control Group.
STARTED   35 [1]   27 [2] 
Clinical Data Collection &Pre/Postop MRI   32 [3]   27 
COMPLETED   22 [4]   20 [4] 
NOT COMPLETED   13   7 
Did not have intended surgery                3                0 
Death                3                3 
Withdrawal by Subject                7                4 
[1] 3 did not have intended surgery; 28 had all 3 doses; 4 had 1 dose but no more due to delayed surgery
[2] 25 had 3 doses; 1 had 1 dose due to rash; 1 had 2 doses and 1 dose of EPO due to pharmacy error
[3] 3 not having intended surgery are subtracted from original 35 subjects, leaving 32
[4] Competed 12 month neurodevelopmental exam, which are the only results published at this time.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These were the number of subjects followed for the intention-to-treat analysis because they received at least one dose of study drug/placebo.

Reporting Groups
  Description
EPO Group

Patients randomized to receive the 3 doses of erythropoetin.

Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2

Control Group.

Patients randomized to receive 3 doses of normal saline control.

Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.

Total Total of all reporting groups

Baseline Measures
   EPO Group   Control Group.   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   27   59 
Age [1] 
[Units: Days]
Mean (Standard Deviation)
 8.94  (5.35)   8.12  (4.09)   8.58  (4.85) 
[1] Age at inclusion surgery
Gender 
[Units: Participants]
Count of Participants
     
Female      16  50.0%      11  40.7%      27  45.8% 
Male      16  50.0%      16  59.3%      32  54.2% 
Cardiac diagnosis 
[Units: Participants]
     
Hypoplastic Left Heart Syndrome (HLHS)   16   10   26 
(D-Transposition of the Great Arteries (D-TGA)   9   12   21 
Aortic Arch & Ventricular Septal Defect/Other   7   5   12 
Any preoperative MRI injury 
[Units: Participants]
     
Injury   13   9   22 
No Injury   19   18   37 
New postoperative MRI injury 
[Units: Participants]
     
Injury   13   13   26 
No Injury   19   14   33 


  Outcome Measures

1.  Primary:   Scores on Bayley Scales of Infant Development III at Age 1 Years.   [ Time Frame: 1 year postoperatively ]

2.  Primary:   MRI Severity of Injury Score   [ Time Frame: 7 days postoperatively. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures).   [ Time Frame: 72 hours postoperatively. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose.   [ Time Frame: 24 hours after first EPO dose. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Dean B. Andropoulos
Organization: Baylor College of Medicine
phone: 832-826-5831
e-mail: dra@bcm.edu


Publications of Results:
Other Publications:


Responsible Party: Dean Andropoulos, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00513240     History of Changes
Other Study ID Numbers: R21HD5550101
FDA IND #100011
Baylor GCRC #0942
First Submitted: August 7, 2007
First Posted: August 8, 2007
Results First Submitted: January 24, 2014
Results First Posted: May 19, 2014
Last Update Posted: January 6, 2017