The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

Duke University

Status: Completed

Conditions: Extracorporeal Membrane Oxygenation

Treatments: Biological: Fresh frozen plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT01903863

Pro00040223

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Scheduled fresh frozen plasma

Experimental group

Description:

Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.

Treatment:

Biological: Fresh frozen plasma

Control

Active Comparator group

Description:

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.

Treatment:

Biological: Fresh frozen plasma