Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists MedDRA version: 12.1 Level: LLT Classification code 10037045 Term: Prothrombin deficiency
Conditions
Interventions
Trade Name: Prothromplex TOTAL 600 IU powder and solvent for solution for injection.
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Human Coagulation Factor I
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To collect information on the shortening of prothrombin time (PT) •To assess in-vivo recovery of clotting factors II, VII, IX and X at 30 (±5) minutes post administration of Prothromplex Total •To assess safety of Prothromplex Total when administered to patients with acquired coagulopathy due to treatment with oral anticoagulants, with respect to clinically observed adverse drug reactions and coagulation markers ;Main Objective: •To evaluate the efficacy of Prothromplex Total in the reversal of effects of oral anticoagulant therapy with respect to normalisation of increased international normalised ratio (INR);Primary end point(s): Proportion of subjects who achieve normalisation of INR to = 1,3 within 30 (±5) minutes post administration of Prothromplex Total | — |
Countries
Austria, Hungary
Outcome results
None listed