NCT00968565

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

Regional Citrate Anticoagulation in ECMO

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 1 Day – 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital
• Respiratory Insufficiency

Interventions

Type	Name	Description
DRUG	sodium citrate	Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2009-08-31
• Last updated: 2015-06-03

Locations

1 site across 1 country: United States