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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00968565
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):

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
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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    Key Record Dates
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:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Congenital Abnormalities
Heart Defects, Congenital
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Heparin
Citric Acid
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Calcium Chelating Agents
Chelating Agents
Sequestering Agents