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OpenTrials
Completed

NCT Number: NCT00168077

Prothrombin Complex Concentrate for Anticoagulant Reversal

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.

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Key information

Conditions

Acquired Coagulation Factor Deficiency Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Trials Registration Coordinator, Feldkirch, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
  • INR > 2 at baseline

Key Exclusion Criteria:

  • Acute thromboembolic event
  • Treatment with any other investigational drug in the last 30 days before study entry
  • Less than 2 weeks of stable oral anticoagulation

Treatment and study plan

Prothrombin Complex Concentrate

Drug

Primary outcomes

  1. Rapid reversal of anticoagulatory effect

Secondary outcomes

  1. Clinical efficacy assessment (hemostatic effect)

  2. Increase of coagulation factors

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

Efficacy and Tolerance of BERIPLEX® P/N in Subjects With Acquired Deficiency of Coagulation Factors II, VII, IX and X Due to Oral Anticoagulation

Important dates

Study start
2005
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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