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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01903863
Enrollment
31
Registered
2013-07-19
Start date
2013-07-31
Completion date
2016-04-30
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation

Keywords

FFP, fresh frozen plasma, ECMO, extracorporeal membrane oxygenation, anticoagulation, transfusion

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.

Interventions

BIOLOGICALFresh 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ECMO Pump LongevityECMO 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

MeasureTime frameDescription
Antithrombin LevelsECMO course (median 198 hours)Compared antithrombin levels in neonates in control versus treatment group
Plasma Free HemoglobinECMO course (median 198 hours)Compare plasma free hemoglobin levels between control and treatment group
Red Blood Cell TransfusionECMO course (median 198 hours)Compared red blood cell transfusion during ECMO for control versus treatment group
Hemorrhagic and Thrombotic ComplicationsECMO course (median 198 hours)Complications associated with coagulation in both the patient and the pump will be collected.
Platelets Transfusion RequirementECMO course (median 198 hours)Compared platelet transfusion during ECMO for control versus treatment group
Fresh Frozen Plasma Transfusion RequirementsECMO course (median 198 hours)Compared fresh frozen plasma transfusion during ECMO for control versus treatment group
Time to Therapeutic aPTTECMO course (median 198 hours)Compared time in hours to goal aPTT for control versus treatment group

Countries

United States

Participant flow

Participants by arm

ArmCount
Scheduled Fresh Frozen Plasma
Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours. 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.
15
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. 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.
16
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision20

Baseline characteristics

CharacteristicControlScheduled Fresh Frozen PlasmaTotal
Age, Categorical
<=18 years
16 Participants15 Participants31 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous0.063 years0.33 years0.096 years
Region of Enrollment
United States
16 Participants15 Participants31 Participants
Sex: Female, Male
Female
9 Participants6 Participants15 Participants
Sex: Female, Male
Male
7 Participants9 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
6 / 158 / 16
other
Total, other adverse events
0 / 150 / 16
serious
Total, serious adverse events
5 / 151 / 16

Outcome results

Primary

ECMO Pump Longevity

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

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaECMO Pump Longevity187 hours
ControlECMO Pump Longevity131 hours
p-value: 0.39Wilcoxon (Mann-Whitney)
Secondary

Antithrombin Levels

Compared antithrombin levels in neonates in control versus treatment group

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaAntithrombin Levels71 percentage of antithrombin
ControlAntithrombin Levels63 percentage of antithrombin
p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary

Fresh Frozen Plasma Transfusion Requirements

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

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaFresh Frozen Plasma Transfusion Requirements10.1 ml/kilogram/ECMO day
ControlFresh Frozen Plasma Transfusion Requirements8.8 ml/kilogram/ECMO day
p-value: 0.95Wilcoxon (Mann-Whitney)
Secondary

Hemorrhagic and Thrombotic Complications

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

Time frame: ECMO course (median 198 hours)

ArmMeasureGroupValue (NUMBER)
Scheduled Fresh Frozen PlasmaHemorrhagic and Thrombotic ComplicationsIntracranial hemorrhage5 participants
Scheduled Fresh Frozen PlasmaHemorrhagic and Thrombotic ComplicationsSurgical site bleed2 participants
Scheduled Fresh Frozen PlasmaHemorrhagic and Thrombotic ComplicationsGastrointestinal hemrrohage2 participants
Scheduled Fresh Frozen PlasmaHemorrhagic and Thrombotic ComplicationsStroke1 participants
ControlHemorrhagic and Thrombotic ComplicationsStroke1 participants
ControlHemorrhagic and Thrombotic ComplicationsIntracranial hemorrhage1 participants
ControlHemorrhagic and Thrombotic ComplicationsGastrointestinal hemrrohage1 participants
ControlHemorrhagic and Thrombotic ComplicationsSurgical site bleed2 participants
p-value: 0.07Fisher Exact
p-value: 0.7Fisher Exact
p-value: 0.5Fisher Exact
Secondary

Plasma Free Hemoglobin

Compare plasma free hemoglobin levels between control and treatment group

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaPlasma Free Hemoglobin47 mg/dL
ControlPlasma Free Hemoglobin56 mg/dL
p-value: 0.8Wilcoxon (Mann-Whitney)
Secondary

Platelets Transfusion Requirement

Compared platelet transfusion during ECMO for control versus treatment group

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaPlatelets Transfusion Requirement12.5 ml/kilogram/ECMO day
ControlPlatelets Transfusion Requirement24.8 ml/kilogram/ECMO day
p-value: 0.12Wilcoxon (Mann-Whitney)
Secondary

Red Blood Cell Transfusion

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

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaRed Blood Cell Transfusion7.2 ml/kilogram/ECMO day
ControlRed Blood Cell Transfusion4.7 ml/kilogram/ECMO day
p-value: 0.37Wilcoxon (Mann-Whitney)
Secondary

Time to Therapeutic aPTT

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

Time frame: ECMO course (median 198 hours)

ArmMeasureValue (MEDIAN)
Scheduled Fresh Frozen PlasmaTime to Therapeutic aPTT658 hours
ControlTime to Therapeutic aPTT676 hours
p-value: 0.8Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026