Duke University Medical Center PICU and PCICU
Durham, North Carolina, 27710, United States
NCT Number: NCT01903863
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.
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Notify Me1 day–18 year
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: FFP, plasma
Time frame: 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
Time frame: ECMO course (median 198 hours)
Complications associated with coagulation in both the patient and the pump will be collected.
Time frame: ECMO course (median 198 hours)
Compared antithrombin levels in neonates in control versus treatment group
Time frame: ECMO course (median 198 hours)
Compare plasma free hemoglobin levels between control and treatment group
Time frame: ECMO course (median 198 hours)
Compared red blood cell transfusion during ECMO for control versus treatment group
Time frame: ECMO course (median 198 hours)
Compared time in hours to goal aPTT for control versus treatment group
Time frame: ECMO course (median 198 hours)
Compared platelet transfusion during ECMO for control versus treatment group
Time frame: ECMO course (median 198 hours)
Compared fresh frozen plasma transfusion during ECMO for control versus treatment group
Duke University
Other
Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
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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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