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Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal

NCT03064035 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-09-14

Study results available
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Summary

The goal of this study is to determine if a fixed dose of 4-factor prothrombin complex concentrate (4FPCC) is as effective as the current standard of care. 4FPCC is used to reverse the effects of warfarin when a patient has emergent bleeding. The investigators hope that this study will help doctors treat patients quicker in the future. In addition, it may be cheaper for patients and hospitals. This is the same medication the doctor would use to reverse warfarin's effects, but at a lower dose.

Hypothesis: A fixed dose of 4FPCC will be comparable to FDA-approved variable dosing for reversal of warfarin-induced anticoagulation (defined as an international normalized ratio \[INR\] ≤ 1.5) in patients with an INR ≥2 experiencing an emergent bleed or requiring emergent surgery.

Conditions

  • Acute Bleeding on Long-Term Anticoagulation Therapy
  • Hemorrhage
  • Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time)
  • Urgent Reversal of Vitamin K Antagonist (VKA) Anticoagulation

Interventions

DRUG

4-factor prothrombin complex concentrate (4FPCC)

4-factor prothrombin complex concentrate (4FPCC) contains all of the vitamin K-dependent clotting factors inhibited by warfarin, making it desirable for use in warfarin reversal for emergent bleeds. Multiple guidelines currently recommend 4FPCC for warfarin reversal in vitamin K-dependent major bleeding or intracranial hemorrhage. 4FPCC has a fast onset of action and has demonstrated significant reversal of INR within 10 minutes. Its duration of action is up to 8 hours, and for this reason it should be given concurrently with vitamin K. Vitamin K has a delayed onset of action due to its need to stimulate the synthesis of clotting factors so its effects begin as the effects of 4FPCC diminish. 4FPCC is the standard of care treatment for this clinical population in the Regions Hospital Emergency Department.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Zachary Stoecker, PharmD · Regions Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2019-04-17
Completion
2019-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03064035 on ClinicalTrials.gov