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Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed

NCT02565836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 342

Last updated 2017-10-25

No results posted yet for this study

Summary

This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated major hemorrhage.

Conditions

Interventions

DRUG

fixed-dose activated prothrombin complex concentrate

FEIBA VH 500 units IV one time for INR less than 5. FEIBA VH 1000 units IV one time for INR greater than 5. Check INR after infusion and may repeat dose if INR still elevated

DRUG

variable-dose inactivated prothrombin complex concentrate

Kcentra 25 units/kg IV one time for INR less than 4. Kcentra 35 units/kg IV one-time for INR 4 to 6. Kcentra 50 units/kg IV one-time for INR greater than 6. Check INR after infusion and may repeat dose if INR still elevated.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Gary D Peksa, PharmD · Rush University Medical Center

  • Robert Mokszycki, PharmD · advocate christ medical center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

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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 NCT02565836 on ClinicalTrials.gov