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

Phase

Condition

Birth Defects

Holoprosencephaly

Lung Injury

Treatment

N/A

Clinical Study ID

NCT00968565

IRB# 090717

Ages < 1
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

January 01, 2010

June 30, 2015

Study 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 been treated worldwide. Bleeding is the most common complication during ECMO because of systemic anticoagulation with heparin. It is most commonly seen in patients following surgery either preceding or while on ECMO support. Regional citrate anticoagulation for hemodialysis was first introduced in 1961. It is the ideal alternative to heparin in patients who are at increased risk for bleeding. It permits effective anticoagulation across the extracorporeal circuit without impacting the patient's systemic coagulation. Citrate functions by binding free calcium, thereby inhibiting coagulation in both the intrinsic and extrinsic coagulation pathways. The purpose of this study is to evaluate the use of citrate as a regional anticoagulant in the ECMO circuit in high risk infants less than one year of age.

Connect with a study center

Vanderbilt Children's Hospital
Nashville, Tennessee 37232
United States
Site Not Available

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