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The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

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ClinicalTrials.gov Identifier: NCT01903863
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Biological: Fresh frozen plasma Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective, Randomized Pilot Study of Prophylactic Fresh Frozen Plasma Administration During Neonatal-Pediatric Extracorporeal Membrane Oxygenation.
Study Start Date : July 2013
Actual Primary Completion Date : February 18, 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Scheduled fresh frozen plasma
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.
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.
Other Name: FFP, plasma

Active Comparator: Control
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.
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.
Other Name: FFP, plasma




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903863


Locations
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United States, North Carolina
Duke University Medical Center PICU and PCICU
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01903863     History of Changes
Other Study ID Numbers: Pro00040223
First Posted: July 19, 2013    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017

Keywords provided by Duke University:
FFP
fresh frozen plasma
ECMO
extracorporeal membrane oxygenation
anticoagulation
transfusion