Total Knee Replacement Surgery Clinical Trial
Official title:
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study
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.
Status | Completed |
Enrollment | 316 |
Est. completion date | March 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Bulgaria | SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology | Pleven | |
Bulgaria | Dept. of Orthopedics, UMHAT "Saint George" | Plovdiv | |
Bulgaria | MHAT Rousse | Rousse | |
Bulgaria | MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology | Sofia | |
Bulgaria | MHAT "Sv. Anna", Department of Orthopaedics and Traumatology | Varna | |
Israel | Soroka MC | Beer - Sheva | |
Israel | Asaf Harofeh MC | Beer-Yaakov | |
Israel | Rambam MC | Haifa | |
Israel | Shaare Zedek MC | Jerusalem | |
Israel | Meir Medical Center (MC) | Kfar Saba | |
Israel | Beilinson Hospital | Petach Tikva | |
Israel | Kaplan MC | Rehovot | |
Israel | Sourasky MC | Tel Aviv | |
Latvia | Ltd "Liepajas regionala slimnica" | Liepaja | |
Latvia | Ltd "Traumatologijas un ortopedijas slimnica" | Riga | |
Latvia | Vidzemes slimnica | Valmiera | |
Poland | Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narzadu Ruchu | Bydgoszcz | |
Poland | Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddzial Kliniczny Ortopedii i Traumatologii Narzadu Ruchu | Kraków | |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji | Lubuskie | |
Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Ortopedii i Traumatologii | Podlaski | |
Poland | Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Oddzial Chirurgii Urazowo-Ortopedycznej i Rehabilitacji | Warszawa | |
Romania | Spitalul Clinic de Urgenta Sf. Ioan Bucuresti | Bucuresti | |
Romania | Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA | Cluj - Napoca | |
Romania | Spitalul Clinic Judetean de Urgenta Craiova | Craiova | |
Russian Federation | Municipal Healthcare Institution "City Clinical Hospital No. 3" | Cheliabinsk | |
Russian Federation | Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov" | Moscow | |
Russian Federation | Municipal Healthcare Institution "City Clinical Hospital No. 4" | Orenburg | |
Russian Federation | Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development" | Saint Petersburg | |
Russian Federation | Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency | Saint Petersburg | |
Russian Federation | Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2" | Saint Petersburg | |
Russian Federation | Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital" | Saint-Petersburg | |
Russian Federation | State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin" | Samara | |
Ukraine | Cherkasska Regional Hospital. Department of Orthopedics and Traumatology. | Cherkassy | |
Ukraine | Ivano-Frank?vsk Regional Clinical Hospital, Department of ortopedics and traumatology. | Ivano-Frankivsk | |
Ukraine | Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology | Odessa |
Lead Sponsor | Collaborator |
---|---|
ThromboGenics | BioInvent International AB, Covance |
Bulgaria, Israel, Latvia, Poland, Romania, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Primary | 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 | No | |
Secondary | Incidence of major bleeding events | All visists from randomization to end of study | Yes | |
Secondary | Incidence of clinically significant non-major bleeding events | All visits from randomization to end of study | Yes | |
Secondary | Incidence of minor bleeding events | All visits from randomization to end of study | Yes | |
Secondary | Incidence of all cause mortality | All visits from randomization to end of study | Yes | |
Secondary | Incidence of adverse events | All visists from randomization to end of study | Yes |
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