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

Early Phase 1

Completed

• Conditions: Heart Defects, Congenital; Respiratory Insufficiency
• Interventions: Drug: sodium citrate

• Registration Number: NCT00968565
• Lead Sponsor: Vanderbilt University

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

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 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.

Study Timeline

• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Study Start: 2010-01
• Status Verified: 2010-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Citrate	sodium citrate	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

Primary Outcome Measures

Name	Time	Method
anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient	hourly

Secondary Outcome Measures

Name	Time	Method
Maintain normal serum calcium levels in patients	hourly

Trial Locations

Locations (1)

Vanderbilt Children's Hospital; 🇺🇸 Nashville, Tennessee, United States