To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: * Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality * Incidence of DVT (total, proximal, distal) * Incidence of nonfatal PE * Incidence of symptomatic VTE (DVT, PE) * VTE caused mortality * Non-VTE caused mortality * Incidence of all hemorrhagic complications * Incidence of major and clinically relevant non-major bleeding * Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
Kazan', Russia
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
Moscow, Russia
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
Moscow, Russia
SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
Moscow, Russia
FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
Nizhny Novgorod, Russia
SBHI "City Clinical Hospital № 4" of the city of Orenburg
Orenburg, Russia
St. Petersburg State Institution of Health "City Hospital № 2"
Saint Petersburg, Russia
SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov
Yaroslavl, Russia
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Incidence of bleeding (safety of selected TeaRx dose)
major and clinically relevant non-major bleeding
Time frame: 6 weeks following total knee replacement
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