Prothrombin Complex Concentrate for Anticoagulant Reversal

CSL Behring40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acquired Coagulation Factor Deficiency

Interventions

Prothrombin Complex ConcentrateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Clinical Trials Registration Coordinator

Feldkirch, Austria

Clinical Trials Registration Coordinator

Vienna, Austria

Outcomes

Primary Outcomes

Rapid reversal of anticoagulatory effect

Secondary Outcomes

Clinical efficacy assessment (hemostatic effect)

Increase of coagulation factors

Data from ClinicalTrials.gov

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