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

Respiratory Insufficiency Clinical Trial

Official title:

Regional Citrate Anticoagulation in ECMO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968565
• Other study ID #: IRB# 090717
• Status: Completed
• Phase: Phase 0
• First received: August 28, 2009
• Last updated: June 1, 2015
• Start date: January 2010
• Est. completion date: June 2015

Study information

• Verified date: June 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Drug:
• sodium citrate
Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit

Locations

Country	Name	City	State
United States	Vanderbilt Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bagshaw SM, Laupland KB, Boiteau PJ, Godinez-Luna T. Is regional citrate superior to systemic heparin anticoagulation for continuous renal replacement therapy? A prospective observational study in an adult regional critical care system. J Crit Care. 2005 Jun;20(2):155-61. — View Citation

Clark JA, Schulman G, Golper TA. Safety and efficacy of regional citrate anticoagulation during 8-hour sustained low-efficiency dialysis. Clin J Am Soc Nephrol. 2008 May;3(3):736-42. doi: 10.2215/CJN.03460807. Epub 2008 Feb 13. — View Citation

Pinnick RV, Wiegmann TB, Diederich DA. Regional citrate anticoagulation for hemodialysis in the patient at high risk for bleeding. N Engl J Med. 1983 Feb 3;308(5):258-61. — View Citation

Suzuki Y, Yamauchi S, Daitoku K, Fukui K, Fukuda I. Extracorporeal membrane oxygenation circulatory support after congenital cardiac surgery. ASAIO J. 2009 Jan-Feb;55(1):53-7. doi: 10.1097/MAT.0b013e31818f0056. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient		hourly	Yes
Secondary	Maintain normal serum calcium levels in patients		hourly	Yes