The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903863
• Other study ID #: Pro00040223
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: April 22, 2016
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center PICU and PCICU	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECMO pump longevity	The primary endpoint is the ECMO pump longevity (measured in hours).	ECMO course, up to 2 months	No
Secondary	Number of Adverse Events	Adverse events associated with coagulation in both the patient and the pump will be collected.	ECMO course, up to 2 months	Yes