Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 circuit anticoagulation is the use of heparin which also anticoagulates the patient and increases the risk of patient bleeding.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Citric Acid; Heparin; Sodium Citrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• Consent denied or unobtainable

• Age greater than one year

• Weight greater than 6 kg

• Gestational age less than 34 weeks