N/A
N=31
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
Extracorporeal Membrane Oxygenation
Bottom Line
View on ClinicalTrials.gov: NCT01903863 ↗Enrolled (actual)
31
Serious AEs
19.4%
Results posted
Jun 2017
Primary outcome: Primary: ECMO Pump Longevity — 187; 131 hours — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fresh frozen plasma (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ECMO Pump Longevity |
187; 131 | 0.39 |
| SECONDARY Hemorrhagic and Thrombotic Complications |
5; 1; 2; 2; 2; 1 | 0.07 |
| SECONDARY Antithrombin Levels |
71; 63 | 0.004 sig |
| SECONDARY Plasma Free Hemoglobin |
47; 56 | 0.8 |
| SECONDARY Red Blood Cell Transfusion |
7.2; 4.7 | 0.37 |
| SECONDARY Time to Therapeutic aPTT |
658; 676 | 0.8 |
| SECONDARY Platelets Transfusion Requirement |
12.5; 24.8 | 0.12 |
| SECONDARY Fresh Frozen Plasma Transfusion Requirements |
10.1; 8.8 | 0.95 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01903863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.