Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
- Registration Number
- NCT00793234
- Lead Sponsor
- ThromboGenics
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.
- Detailed Description
Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3).
Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7).
In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee replacement surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- Male or female patients aged > 18 and < 80 years old
- Female patients should be post menopausal
- Patients undergoing primary elective total knee replacement surgery
- Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Body weight < 50 kg or > 100 kg
- Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee
- Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year
- Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study
- Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
- History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 TB-402 0.3 mg/kg TB-402 3 TB-402 1.2 mg/kg TB-402 2 TB-402 0.6 mg/kg TB-402 4 Enoxaparin -
- Primary Outcome Measures
Name Time Method The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study. All visists from randomization to end of study Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE. Prior to hospital discharge Day 7-11
- Secondary Outcome Measures
Name Time Method Incidence of major bleeding events All visists from randomization to end of study Incidence of clinically significant non-major bleeding events All visits from randomization to end of study Incidence of minor bleeding events All visits from randomization to end of study Incidence of all cause mortality All visits from randomization to end of study Incidence of adverse events All visists from randomization to end of study
Trial Locations
- Locations (35)
Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.
๐บ๐ฆCherkassy, Ukraine
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
๐ท๐บSaint Petersburg, Russian Federation
Ivano-Frankัvsk Regional Clinical Hospital, Department of ortopedics and traumatology.
๐บ๐ฆIvano-Frankivsk, Ukraine
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
๐ท๐บSamara, Russian Federation
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji
๐ต๐ฑLubuskie, Poland
Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development"
๐ท๐บSaint Petersburg, Russian Federation
Ltd "Traumatologijas un ortopedijas slimnica"
๐ฑ๐ปRiga, Latvia
Sourasky MC
๐ฎ๐ฑTel Aviv, Israel
Asaf Harofeh MC
๐ฎ๐ฑBeer-Yaakov, Israel
Municipal Healthcare Institution "City Clinical Hospital No. 3"
๐ท๐บCheliabinsk, Russian Federation
Soroka MC
๐ฎ๐ฑBeer - Sheva, Israel
Beilinson Hospital
๐ฎ๐ฑPetach Tikva, Israel
Shaare Zedek MC
๐ฎ๐ฑJerusalem, Israel
MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
๐ง๐ฌSofia, Bulgaria
MHAT "Sv. Anna", Department of Orthopaedics and Traumatology
๐ง๐ฌVarna, Bulgaria
Wojewรณdzki Szpital Brรณdnowski Samodzielny Publiczny Zakลad Opieki Zdrowotnej, Oddziaล Chirurgii Urazowo-Ortopedycznej i Rehabilitacji
๐ต๐ฑWarszawa, Poland
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
๐ง๐ฌPleven, Bulgaria
Dept. of Orthopedics, UMHAT "Saint George"
๐ง๐ฌPlovdiv, Bulgaria
Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"
๐ท๐บMoscow, Russian Federation
Rambam MC
๐ฎ๐ฑHaifa, Israel
MHAT Rousse
๐ง๐ฌRousse, Bulgaria
Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology
๐บ๐ฆOdessa, Ukraine
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narzฤ du Ruchu
๐ต๐ฑBydgoszcz, Poland
Wojewรณdzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddziaล Kliniczny Ortopedii i Traumatologii Narzฤ du Ruchu
๐ต๐ฑKrakรณw, Poland
Uniwersytecki Szpital Kliniczny w Biaลymstoku, Klinika Ortopedii i Traumatologii
๐ต๐ฑPodlaski, Poland
Ltd "Liepajas regionala slimnica"
๐ฑ๐ปLiepฤja, Latvia
Spitalul Clinic de Urgenta Sf. Ioan Bucuresti
๐ท๐ดBucuresti, Romania
Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA
๐ท๐ดCluj - Napoca, Romania
Meir Medical Center (MC)
๐ฎ๐ฑKfar Saba, Israel
Kaplan MC
๐ฎ๐ฑRehovot, Israel
Municipal Healthcare Institution "City Clinical Hospital No. 4"
๐ท๐บOrenburg, Russian Federation
Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency
๐ท๐บSaint Petersburg, Russian Federation
Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"
๐ท๐บSaint-Petersburg, Russian Federation
Vidzemes slimnica
๐ฑ๐ปValmiera, Latvia
Spitalul Clinic Judetean de Urgenta Craiova
๐ท๐ดCraiova, Romania