The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| End Date: | May 2016 |
Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
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.
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.
Inclusion Criteria:
- All patients < 18 years receiving ECMO
Exclusion Criteria:
1. Planned withdrawal of life sustaining therapy in the next 48 hours
2. Previous enrollment in the study
3. Patients who cannot be consented within 48 hours
4. Pregnant patients
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Caroline Ozment, md
Phone: 919-681-5226
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