NCT01903863

The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extracorporeal Membrane Oxygenation

Interventions

Type	Name	Description
BIOLOGICAL	Fresh frozen plasma	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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-02-18
• Completion: 2016-04-01
• First posted: 2013-07-19
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

1 site across 1 country: United States