Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
- Conditions
- Prophylaxis of Venous Thromboembolic Events
- Interventions
- Registration Number
- NCT01344954
- Lead Sponsor
- ThromboGenics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 632
- Male or female subjects aged ≥ 18 years.
- Written informed consent.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Pregnancy at the time of screening.
- Indication for anticoagulation other than post-operative thromboprophylaxis.
- Active bleeding or high risk of bleeding.
- Anticipated continued use of neuraxial catheter after surgery.
- Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
- Uncontrolled hypertension.
- Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
- Creatinine clearance <30 mL/min.
- Antiplatelet agents other than low dose aspirin (< 200mg).
- The use of intermittent pneumatic compression.
- Known hypersensitivity to contrast media or rivaroxaban.
- Known drug or alcohol abuse.
- Active malignant disease or current cytostatic treatment.
- Stroke within the previous month.
- Participation in an investigational drug study within the past 30 days or previous participation in this study.
- Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10mg QD Rivaroxaban Rivaroxaban - 25mg TB-402 TB-402 - 50mg TB-402 TB-402 -
- Primary Outcome Measures
Name Time Method Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE Randomisation to post-operative day 35
- Secondary Outcome Measures
Name Time Method Incidents of total DVT Randomisation to Post-Operative day 35 Incidents of VTE-related death Randomisation to Post-Operative day 35 Incidents of major VTE Randomisation to Post-Operative day 35 Incidents of proximal/distal DVT Randomisation to Post-Operative day 35 Incidents of pulmonary embolism Randomisation to Post-Operative day 35 Incidents of Major VTE Randomisation to Post-Operative day 70
Trial Locations
- Locations (36)
KRANKENHAUS DES BARMHER.SCHW.Linz
🇦🇹Linz, Austria
Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
🇷🇺Saint-Petersburg, Russian Federation
ZNA Antwerpen Locatie Middelheim
🇧🇪Antwerpen, Belgium
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
🇷🇺Samara, Russian Federation
Orthopädisches Spital Speising
🇦🇹Wien, Austria
Riga 2nd Hospital
🇱🇻Riga, Latvia
Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
🇭🇺Kecskemét, Hungary
MHAT Rousse, Department of Orthopaedics
🇧🇬Rousse, Bulgaria
Pándy Kálmán Kórház
🇭🇺Gyula, Hungary
UMHAT 'Tsaritsa Joanna'
🇧🇬Sofia, Bulgaria
Tolna Megyei Önkormányzat Balassa János Kórháza
🇭🇺Szekszárd, Hungary
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
🇧🇬Pleven, Bulgaria
Ltd "Vidzemes slimnica"
🇱🇻Valmiera, Latvia
Klinika Ortopedii, WIM
🇵🇱Warszawa, Poland
SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
🇺🇦Kharkiv, Ukraine
Public Establishment 'City Hospital #9', orthopedy and traumatology department
🇺🇦Sevastopol, Ukraine
UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
🇧🇬Sofia, Bulgaria
Municipal Healthcare Institution "City Clinical Hospital No. 3"
🇷🇺Chelabinsk, Russian Federation
Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
🇺🇦Cherkassy, Ukraine
Traumatology and Orthopedics Clinic "Adazi", LTD
🇱🇻Adazi, Latvia
Ltd "Liepajas regionala slimnica"
🇱🇻Liepāja, Latvia
NZOZ Szpital w Puszczykowie
🇵🇱Puszczykowo, Poland
Medical University of warsaw, Dept of Orthopaedics
🇵🇱Warsaw, Poland
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
🇷🇺Saint-Petersburg, Russian Federation
Ivano-Frankіvsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frankіvsk National Medical University
🇺🇦Ivano-Frankivsk, Ukraine
Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
🇺🇦Odessa, Ukraine
Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
🇷🇺Orenburg, Russian Federation
Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
🇷🇺Yaroslavl, Russian Federation
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Department of Orthopedics, UMHAT "Sv. Georgi"
🇧🇬Plovdiv, Bulgaria
Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
🇵🇱Łódź, Poland
Diaconessenhuis Leiden
🇳🇱Leiden, Netherlands
Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
🇷🇺Saint-Petersburg, Russian Federation
Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital", Ortopedy and traumatology center of Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital"
🇺🇦Kyiv, Ukraine
AKH Wien
🇦🇹Wien, Austria
Klinika Orthopedii I Traumatologii
🇵🇱Bialystok, Poland