Prothrombin Complex Concentrate for Anticoagulant Reversal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00168077
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 11, 2011
Information provided by:
CSL Behring

Brief 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.

Condition or disease Intervention/treatment Phase
Acquired Coagulation Factor Deficiency Drug: Prothrombin Complex Concentrate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Primary Outcome Measures :
  1. Rapid reversal of anticoagulatory effect

Secondary Outcome Measures :
  1. Clinical efficacy assessment (hemostatic effect)
  2. Increase of coagulation factors

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00168077

Clinical Trials Registration Coordinator
Feldkirch, Austria, 6800
Clinical Trials Registration Coordinator
Wien, Austria, 1090
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Halle/Saale, Germany, 06112
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Hannover, Germany, 30623
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Leipzig, Germany, 04129
For information on sites in Europe, please contact our clinical research team in
Marburg, Germany, 35002
Clinical Trials Registration Coordinator
München, Germany, 81377
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Györ, Hungary, 9023
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Veszprém, Hungary, 8220
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Haifa, Israel, 31096
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Kaunas, Lithuania, 500009
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Vilnius, Lithuania, 08661
Clinical Trials Registration Coordinator
Amsterdam, Netherlands, 1105 AZ
Clinical Trials Registration Coordinator
Warsaw, Poland, 02-097
Clinical Trials Registration Coordinator
Zuerich, Switzerland, 8091
Sponsors and Collaborators
CSL Behring
Principal Investigator: Ingrid Pabinger-Fasching, Prof. Universitätsklinik für Innere Medizin I der Stadt Wien