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

This study has suspended participant recruitment.

(Adverse events in 2 patients - study suspended pending additional animal data)

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00968565

First received: August 28, 2009

Last updated: June 23, 2010

Last verified: June 2010

History of Changes

Purpose

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	Intervention	Phase
Heart Defects, Congenital Respiratory Insufficiency	Drug: sodium citrate	Phase 0

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Regional Citrate Anticoagulation in ECMO

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Calcium Congenital Heart Defects Respiratory Failure

Drug Information available for: Sodium citrate Heparin

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient [ Time Frame: hourly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Maintain normal serum calcium levels in patients [ Time Frame: hourly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	January 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	up to 1 Year
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968565

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. No abstract available.

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.

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. Epub 2008 Feb 13.

Responsible Party:	John B. Pietsch, M.D., Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00968565 History of Changes
Other Study ID Numbers:	IRB# 090717
Study First Received:	August 28, 2009
Last Updated:	June 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

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

Additional relevant MeSH terms:

Congenital Abnormalities
Heart Defects, Congenital
Respiratory Insufficiency
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases

Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

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