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An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

NCT00803101 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2015-04-06

Study results available
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Summary

The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require immediate correction of international normalized ratio (INR) because of emergency surgery.

Conditions

  • Reversal of Coagulopathy

Interventions

BIOLOGICAL

Beriplex® P/N (Kcentra)

Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.

BIOLOGICAL

Fresh frozen plasma

Intravenous infusion, dosage depending on baseline INR and body weight

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director, Clinical R&D · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • United States
  • Belarus
  • Bulgaria
  • Lebanon
  • Romania
  • Russia

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 NCT00803101 on ClinicalTrials.gov