NCT04794348

Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin

A Phase 2, Multisite, Double-Blind, Prospective Randomized, Crossover, Adequate and Well-Controlled Clinical Trial Assessing the Non-Inferiority of Autologous Freeze Dried Plasma (FDP) to Fresh Frozen Plasma (FFP) in Reversing the Anticoagulation Effects of Warfarin in Healthy Volunteers

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Teleflex · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to see how well an experimental freeze dried plasma product, known as FDP, works to reverse the anticoagulation effects of a prescription medication called warfarin sodium (warfarin) compared to a licensed and routinely used plasma product known as fresh frozen plasma (FFP). The study hypothesis is that FDP is not inferior to FFP when used for this purpose. Enrolled subjects are required to undergo a minimum of 4 plasmapheresis procedures, generating approximately 2,400 mL. Half will be used as FFP and half will be manufactured into FDP. Each subject will receive a total of 6 autologous units (approximately 1,620 mL) of plasma product over the course of 2 infusion visits (approximately 810 mL per infusion visit) with a 14 day washout period between infusions. Warfarin will be administered to each subject prior to each infusion visit. Subjects will be randomized to a treatment arm at their first warfarin administration visit leading up to the first infusion. This establishes the sequence of the plasma products to be infused across the 2 infusion visits. Those randomized to receive 3 units of FDP (approximately 810 mL) at the first infusion visit will receive the equivalent dose of FFP at their second infusion visit and vice versa for those randomized to receive 3 units of FFP at the first infusion visit. FDP and FFP will be infused intravenously.

Conditions

• Anticoagulant Reversal

Interventions

Type	Name	Description
BIOLOGICAL	Fresh Frozen Plasma (FFP)	Autologous units of fresh frozen plasma collected from the subject by plasmapheresis
BIOLOGICAL	Freeze Dried Plasma (FDP)	Autologous units of freeze dried plasma manufactured from plasma collected from the subject by plasmapheresis

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-03-12
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study