The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
632
Administered intravenously over 10 minutes
Administered orally as a capsule once a day for 35 days
Administered intravenously over 10 minutes
Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE
Time frame: Randomisation to post-operative day 35
Incidents of major VTE
Time frame: Randomisation to Post-Operative day 35
Incidents of total DVT
Time frame: Randomisation to Post-Operative day 35
Incidents of proximal/distal DVT
Time frame: Randomisation to Post-Operative day 35
Incidents of pulmonary embolism
Time frame: Randomisation to Post-Operative day 35
Incidents of VTE-related death
Time frame: Randomisation to Post-Operative day 35
Incidents of Major VTE
Time frame: Randomisation to Post-Operative day 70
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KRANKENHAUS DES BARMHER.SCHW.Linz
Linz, Austria
AKH Wien
Vienna, Austria
Orthopädisches Spital Speising
Vienna, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
ZNA Antwerpen Locatie Middelheim
Antwerp, Belgium
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven, Bulgaria
Department of Orthopedics, UMHAT "Sv. Georgi"
Plovdiv, Bulgaria
MHAT Rousse, Department of Orthopaedics
Rousse, Bulgaria
UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
Sofia, Bulgaria
UMHAT 'Tsaritsa Joanna'
Sofia, Bulgaria
...and 26 more locations