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

• ClinicalTrials.gov Identifier: NCT00968565
• Recruitment Status: Completed
• First Posted: August 31, 2009
• Last Update Posted: June 3, 2015
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): John B. Pietsch, Vanderbilt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Defects, Congenital; Respiratory Insufficiency	Drug: sodium citrate	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Regional Citrate Anticoagulation in ECMO
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: sodium citrate; Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit

Outcome Measures

Primary Outcome Measures :

1. anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient [ Time Frame: hourly ]

Secondary Outcome Measures :

1. Maintain normal serum calcium levels in patients [ Time Frame: hourly ]

Eligibility Criteria

• Ages Eligible for Study: up to 1 Year (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt Children's Hospital

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

• Principal Investigator: John B Pietsch, MD; Vanderbilt University

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: John B. Pietsch, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT00968565 History of Changes
• Other Study ID Numbers: IRB# 090717
• First Posted: August 31, 2009
• Last Update Posted: June 3, 2015
• Last Verified: June 2010

Keywords provided by John B. Pietsch, Vanderbilt University:

Heart Defects, Congenital; Extracorporeal Membrane Oxygenation; Citric Acid; Heparin; Respiratory Insufficiency

Additional relevant MeSH terms:

Heart Diseases; Heparin; Respiratory Insufficiency; Pulmonary Valve Insufficiency; Heart Defects, Congenital; Congenital Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Heart Valve Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Citric Acid; Sodium Citrate; Anticoagulants; Calcium Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents