Clinical trial NCT00168077: Prothrombin Complex Concentrate for Anticoagulant Reversal
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acquired Coagulation Factor Deficiency
Keywords: Prothrombin Complex Concentrate
Anticoagulant reversal
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rapid reversal of anticoagulatory effect
Secondary outcomes:
measure: Clinical efficacy assessment (hemostatic effect)
measure: Increase of coagulation factors
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Clinical Trials Registration Coordinator
city: Wien
country: Austria
facility: Clinical Trials Registration Coordinator
city: Halle/Saale
country: Germany
facility: Clinical Trials Registration Coordinator
city: Hannover
country: Germany
facility: Clinical Trials Registration Coordinator
city: Leipzig
country: Germany
facility: Clinical Trials Registration Coordinator
city: Marburg
country: Germany
facility: For information on sites in Europe, please contact our clinical research team in
city: München
country: Germany
facility: Clinical Trials Registration Coordinator
city: Györ
country: Hungary
facility: Clinical Trials Registration Coordinator
city: Veszprém
country: Hungary
facility: Clinical Trials Registration Coordinator
city: Haifa
country: Israel
facility: Clinical Trials Registration Coordinator
city: Kaunas
country: Lithuania
facility: Clinical Trials Registration Coordinator
city: Vilnius
country: Lithuania
facility: Clinical Trials Registration Coordinator
city: Amsterdam
country: Netherlands
facility: Clinical Trials Registration Coordinator
city: Warsaw
country: Poland
facility: Clinical Trials Registration Coordinator
city: Zuerich
country: Switzerland
facility: Clinical Trials Registration Coordinator
Study officials:
affiliation: Universitätsklinik für Innere Medizin I der Stadt Wien
name: Ingrid Pabinger-Fasching, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.
citation: Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010 Mar;89(3):309-16. doi: 10.1007/s00277-009-0830-7. Epub 2009 Sep 29.