Clinical trial NCT00968565: Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)
Official title: Regional Citrate Anticoagulation in ECMO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Heart Defects, Congenital
Respiratory Insufficiency
Keywords: Heart Defects, Congenital
Extracorporeal Membrane Oxygenation
Citric Acid
Heparin
Respiratory Insufficiency
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-08-31
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient
timeFrame: hourly
Secondary outcomes:
measure: Maintain normal serum calcium levels in patients
timeFrame: hourly
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: John B Pietsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJM198302033080506. No abstract available.
citation: 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. doi: 10.1016/j.jcrc.2005.01.001.
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.
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.