The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
- Conditions
- Extracorporeal Membrane Oxygenation
- Interventions
- Biological: Fresh frozen plasma
- Registration Number
- NCT01903863
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- All patients < 18 years receiving ECMO
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Scheduled fresh frozen plasma Fresh frozen plasma Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. Control Fresh frozen plasma 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.
- Primary Outcome Measures
Name Time Method ECMO Pump Longevity ECMO course (median 198 hours) 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
- Secondary Outcome Measures
Name Time Method Red Blood Cell Transfusion ECMO course (median 198 hours) Compared red blood cell transfusion during ECMO for control versus treatment group
Antithrombin Levels ECMO course (median 198 hours) Compared antithrombin levels in neonates in control versus treatment group
Platelets Transfusion Requirement ECMO course (median 198 hours) Compared platelet transfusion during ECMO for control versus treatment group
Plasma Free Hemoglobin ECMO course (median 198 hours) Compare plasma free hemoglobin levels between control and treatment group
Time to Therapeutic aPTT ECMO course (median 198 hours) Compared time in hours to goal aPTT for control versus treatment group
Hemorrhagic and Thrombotic Complications ECMO course (median 198 hours) Complications associated with coagulation in both the patient and the pump will be collected.
Fresh Frozen Plasma Transfusion Requirements ECMO course (median 198 hours) Compared fresh frozen plasma transfusion during ECMO for control versus treatment group
Trial Locations
- Locations (1)
Duke University Medical Center PICU and PCICU
🇺🇸Durham, North Carolina, United States