Congenital Bleeding Disorder Clinical Trial
Official title:
A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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