The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.

Official Title
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Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.

Conditions
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Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Biological: Fresh frozen plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients < 18 years receiving ECMO Exclusion Criteria: Planned withdrawal of life sustaining therapy in the next 48 hours Previous enrollment in the study Patients who cannot be consented within 48 hours Pregnant patients

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scheduled fresh frozen plasma<br>Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. | Biological: Fresh frozen plasma<br>* Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.<br>* Other names: FFP, plasma;|
| Active Comparator: Control<br>Patients in this arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period. | Biological: Fresh frozen plasma<br>* Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.<br>* Other names: FFP, plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECMO Pump Longevity | The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours | ECMO course (median 198 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhagic and Thrombotic Complications | Complications associated with coagulation in both the patient and the pump will be collected. | ECMO course (median 198 hours) | 
| Antithrombin Levels | Compared antithrombin levels in neonates in control versus treatment group | ECMO course (median 198 hours) | 
| Plasma Free Hemoglobin | Compare plasma free hemoglobin levels between control and treatment group | ECMO course (median 198 hours) | 
| Red Blood Cell Transfusion | Compared red blood cell transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) | 
| Time to Therapeutic aPTT | Compared time in hours to goal aPTT for control versus treatment group | ECMO course (median 198 hours) | 
| Platelets Transfusion Requirement | Compared platelet transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) | 
| Fresh Frozen Plasma Transfusion Requirements | Compared fresh frozen plasma transfusion during ECMO for control versus treatment group | ECMO course (median 198 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FFP, fresh frozen plasma, ECMO, extracorporeal membrane oxygenation, anticoagulation, transfusion