Prothrombin Complex Concentrate for Anticoagulant Reversal - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00168077

Purpose

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	Intervention	Phase
Acquired Coagulation Factor Deficiency	Drug: Prothrombin Complex Concentrate	Phase III

MedlinePlus related topics: Blood Thinners

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Rapid reversal of anticoagulatory effect

Secondary Outcome Measures:

Clinical efficacy assessment (hemostatic effect)
Increase of coagulation factors

Estimated Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168077

Locations

Germany
For information on sites in Europe, please contact our clinical research team in
Marburg, Germany, 35002

Sponsors and Collaborators

CSL Behring

Investigators

Principal Investigator:

Ingrid Pabinger-Fasching, Prof.

Universitätsklinik für Innere Medizin I der Stadt Wien

More Information

Publications of Results:

Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. Epub 2008 Jan 15.

Study ID Numbers:	BE1116_3001
Study First Received:	September 12, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00168077
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by CSL Behring:

Prothrombin Complex Concentrate
Anticoagulant reversal

Study placed in the following topic categories:

Thrombin
Malnutrition

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 13, 2009