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.

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.

Study Overview

• Status: Completed
• Conditions: Extracorporeal Membrane Oxygenation
• Intervention / Treatment: Biological: Fresh frozen plasma

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center PICU and PCICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: FFP, plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	ECMO course (median 198 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemorrhagic and Thrombotic Complications	Complications associated with coagulation in both the patient and the pump will be collected.	ECMO course (median 198 hours)
Antithrombin Levels	Compared antithrombin levels in neonates in control versus treatment group	ECMO course (median 198 hours)
Plasma Free Hemoglobin	Compare plasma free hemoglobin levels between control and treatment group	ECMO course (median 198 hours)
Red Blood Cell Transfusion	Compared red blood cell transfusion during ECMO for control versus treatment group	ECMO course (median 198 hours)
Time to Therapeutic aPTT	Compared time in hours to goal aPTT for control versus treatment group	ECMO course (median 198 hours)
Platelets Transfusion Requirement	Compared platelet transfusion during ECMO for control versus treatment group	ECMO course (median 198 hours)
Fresh Frozen Plasma Transfusion Requirements	Compared fresh frozen plasma transfusion during ECMO for control versus treatment group	ECMO course (median 198 hours)

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 18, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 17, 2013
• First Posted (Estimate): July 19, 2013

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: ECMO; anticoagulation; transfusion; extracorporeal membrane oxygenation; FFP; fresh frozen plasma
• Other Study ID Numbers: Pro00040223