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N/A N=31 Randomized Other

The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

Extracorporeal Membrane Oxygenation

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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