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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Regional Citrate Anticoagulation in ECMO

Conditions
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Heart Defects, Congenital, Respiratory Insufficiency

Intervention / Treatment
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* Drug: sodium citrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrate<br>Sodium citrate will be infused as the blood enters the ECMO circuit and calcium chloride will be infused as the blood leaves the ECMO circuit and enters the patient | Drug: sodium citrate<br>* Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient |  | hourly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintain normal serum calcium levels in patients |  | hourly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Defects, Congenital, Extracorporeal Membrane Oxygenation, Citric Acid, Heparin, Respiratory Insufficiency