Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal

Baxalta

Status and phase

Completed

Phase 4

Conditions

Prothrombin Complex Factor Deficiency

Treatments

Biological: Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159210

2010-019250-41 (EudraCT Number)

220901

Details and patient eligibility

About

The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.

Enrollment

61 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
Subject or parent/legally authorised representative has provided written informed consent
Subject has INR >= 2,0 at screening
Subject is willing and able to comply with the requirements of the protocol

Exclusion criteria

Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
Subject has blood loss of >= 5 units of blood
Subject has hereditary thrombophilia or bleeding disorder
Subject has a life expectancy of < 3 months
Subject has been on oral anticoagulant treatment for a period of < 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
Subject has an acute ischemic cardiovascular disorder
Subject has or is suspected to have sepsis
Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study