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

NCT04794348 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • United States Army Medical Materiel Development Activity

    collaborator FED

  • Westat

    collaborator OTHER

  • Teleflex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-31
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794348 on ClinicalTrials.gov