The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

NCT01903863 | Completed Results

• 1 other identifier: Pro00040223
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hemorrhagic and Thrombotic Complications

  ECMO course (median 198 hours)

• Antithrombin Levels

  ECMO course (median 198 hours)

• Plasma Free Hemoglobin

  ECMO course (median 198 hours)

• Red Blood Cell Transfusion

  ECMO course (median 198 hours)

• Time to Therapeutic aPTT

  ECMO course (median 198 hours)

Study Arms (2)

Scheduled fresh frozen plasma

EXPERIMENTAL

Patients enrolled in this arm will receive scheduled fresh frozen plasma treatment every 48 hours.

Biological: Fresh frozen plasma

Control

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: FFP, plasma

Control; Scheduled fresh frozen plasma

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients \< 18 years receiving ECMO

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center PICU and PCICU

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Dr. Caroline Ozment
• Organization: Duke University Hospital

919-681-2554

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2013
• Primary Completion: February 18, 2016
• Study Completion: April 1, 2016
• Last Updated: June 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-05

Locations

US (1)