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Prothrombin Complex Concentrate for Anticoagulant Reversal

NCT00168077 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-02-11

No results posted yet for this study

Summary

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

Conditions

  • Acquired Coagulation Factor Deficiency

Interventions

DRUG

Prothrombin Complex Concentrate

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Ingrid Pabinger-Fasching, Prof. · Universitätsklinik für Innere Medizin I der Stadt Wien

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2006-11-30

Countries

  • Austria
  • Germany
  • Hungary
  • Israel
  • Lithuania
  • Netherlands
  • Poland
  • Switzerland

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 NCT00168077 on ClinicalTrials.gov