This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state. The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
Unnamed facility
Lille, France
Unnamed facility
München, Germany
Unnamed facility
Tel Litwinsky, Israel
TEG® (Thromboelastography) parameters after dosing of trial product
ROTEM® (Thromboelastometry) parameters after dosing of trial product
TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII
Serious adverse events and non-serious adverse events
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