AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH ACQUIRED PROTHROMBIN COMPLEX COAGULATION FACTORS (II, VII, IX, X) DEFICIENCY - Efficacy and safety of Prothromplex Total in Reversal of Oral Anticoagulatio

• Conditions: Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists; MedDRA version: 12.1Level: LLTClassification code 10037045Term: Prothrombin deficiency

• Registration Number: EUCTR2010-019250-41-HU
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Subject is at least 18 years of age at enrolment with acquired prothrombin complex coagulation factor (II, VII, IX, X) deficiency, due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, invasive procedure or acute bleeding episode
•Subject has provided written informed consent
•Subject has INR = 2.0 at screening
•Subject must have been on stable doses of anticoagulant or has a known history of stable INR for at least 72 hours prior to screening
•Subject is willing and able to comply with the requirements of the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Subject has laboratory and/or clinical symptoms which are clearly indicative of 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 PCC constituents (including heparin-induced thrombocytopenia)
•Subject has blood loss of = 5 units of blood
•Subject has known congenital Protein C, Protein S, or Antithrombin deficiency, or hereditary 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 ischaemic 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 renal failure undergoing dialysis
•Subject has participated in another clinical study involving an IP or device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or device during the course of this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified