This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Human prothrombin complex concentrate
PRA Health Sciences
Groningen, Netherlands
Peak thrombin generation at 30 minutes after end of the Cofact infusion
Time frame: 30 minutes post Cofact infusion
Changes in ETP
Change in endogenous thrombin potential (ETP) over 24 hours after the EOI
Time frame: 24 hours post Cofact infusion
Concentration in clotting factors
Changes in aPTT, PT, and INR
Time frame: up to Day 15
Coagulation markers
Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S
Time frame: up to Day 15
Coagulation activation markers
Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs)
Time frame: up to Day 15
Safety outcome
Frequency and severity of adverse events (AEs)
Time frame: up to Day 15
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