Status:
COMPLETED
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
Lead Sponsor:
ThromboGenics
Collaborating Sponsors:
BioInvent International AB
Covance
Conditions:
Total Knee Replacement Surgery
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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). I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00793234
Start Date
December 1 2008
End Date
March 1 2010
Last Update
April 7 2014
Active Locations (35)
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1
SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven, Bulgaria, 5800
2
Dept. of Orthopedics, UMHAT "Saint George"
Plovdiv, Bulgaria, 4002
3
MHAT Rousse
Rousse, Bulgaria, 7002
4
MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
Sofia, Bulgaria, 1709