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Completed

NCT Number: NCT01903863

The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

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.

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center PICU and PCICU

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fresh frozen plasma

Biological

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.

Other names: FFP, plasma

Primary outcomes

  1. ECMO Pump Longevity

    Time frame: ECMO course (median 198 hours)

    The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours

Secondary outcomes

  1. Hemorrhagic and Thrombotic Complications

    Time frame: ECMO course (median 198 hours)

    Complications associated with coagulation in both the patient and the pump will be collected.

  2. Antithrombin Levels

    Time frame: ECMO course (median 198 hours)

    Compared antithrombin levels in neonates in control versus treatment group

  3. Plasma Free Hemoglobin

    Time frame: ECMO course (median 198 hours)

    Compare plasma free hemoglobin levels between control and treatment group

  4. Red Blood Cell Transfusion

    Time frame: ECMO course (median 198 hours)

    Compared red blood cell transfusion during ECMO for control versus treatment group

  5. Time to Therapeutic aPTT

    Time frame: ECMO course (median 198 hours)

    Compared time in hours to goal aPTT for control versus treatment group

  6. Platelets Transfusion Requirement

    Time frame: ECMO course (median 198 hours)

    Compared platelet transfusion during ECMO for control versus treatment group

  7. Fresh Frozen Plasma Transfusion Requirements

    Time frame: ECMO course (median 198 hours)

    Compared fresh frozen plasma transfusion during ECMO for control versus treatment group

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2013
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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