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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Citrate Anticoagulation for Postdilution Hemofiltration

NCT03969966

Acute Kidney Injury Critical Illness

UNKNOWN

The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients

NCT03470727

Hemodialysis Citrate Heparin

COMPLETED NA

The Effectiveness and Safety of 4% Sodium Citrate as a Lock Solution in Central Venous Hemodialysis Catheter

NCT05188339

Central Venous Catheter Thrombosis Renal Dialysis

UNKNOWN PHASE2/PHASE3

Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment

NCT01092455

Renal Dialysis

COMPLETED

Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

NCT00948558

Acute Kidney Failure With or Without: MODS Sepsis +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Defects, Congenital Respiratory Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

sodium citrate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sodium citrate

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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