Status:
COMPLETED
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Lead Sponsor:
Tetherex Pharmaceuticals Corporation
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee repla...
Eligibility Criteria
Inclusion
- Key
- Males or females, 18-80 years of age (inclusive)
- Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia
- Key
Exclusion
- Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year
- Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less))
- Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2019
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT03812328
Start Date
February 20 2019
End Date
November 14 2019
Last Update
January 6 2021
Active Locations (21)
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1
UMHAT Kanev AD
Rousse, Bulgaria
2
Acibadem City Clinic Tokuda Hospital EAD
Sofia, Bulgaria
3
UMHAT Tsaritsa Yoanna - ISUL
Sofia, Bulgaria
4
Regional Hospital of Liepaja
Liepāja, Latvia