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

Completed · Early Phase 1

Conditions studied: Heart Defects, Congenital, Respiratory Insufficiency

In brief

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.

Key facts

Study ID

NCT00968565

Run by

Vanderbilt University

People needed

2

Starts

2010-01-01

Expected to finish

2015-06-01

Last updated by the study team

2015-06-03

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Consent denied or unobtainable
• Age greater than one year
• Weight greater than 6 kg
• Gestational age less than 34 weeks

Where it is running

• Vanderbilt Children's Hospital — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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