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Completed

NCT Number: NCT00968565

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

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.

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Key information

Conditions

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

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium citrate

Drug

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

Primary outcomes

  1. anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient

    Time frame: hourly

Secondary outcomes

  1. Maintain normal serum calcium levels in patients

    Time frame: hourly

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Regional Citrate Anticoagulation in ECMO

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2009
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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