Status:
COMPLETED
Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)
Lead Sponsor:
Vanderbilt University
Conditions:
Heart Defects, Congenital
Respiratory Insufficiency
Eligibility:
All Genders
1-1 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine the safety and efficacy of citrate to provide anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of providing ECMO circui...
Detailed Description
Extracorporeal membrane oxygenation (ECMO) is a form of extended heart/lung bypass support that has been used to treat more than 650 patients over 20 years at Vanderbilt. Over 29,000 patients have bee...
Eligibility Criteria
Inclusion
- Infant less than one year of age and less than 6 kg
- Informed consent obtained from parent
- One or more of the following diagnoses:
- Post-op congenital heart surgery
- Congenital diaphragmatic hernia
- Sepsis with coagulopathy not corrected prior to ECMO
- Other newborn diagnosis with Grade I or II IVH
- Infant requires/is on ECMO
Exclusion
- Consent denied or unobtainable
- Age greater than one year
- Weight greater than 6 kg
- Gestational age less than 34 weeks
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00968565
Start Date
January 1 2010
End Date
June 1 2015
Last Update
June 3 2015
Active Locations (1)
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1
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232