The purpose of the study is to evaluate the efficacy and safety of SHR-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,166
SHR-2004 injection in low dose.
SHR-2004 injection in high dose.
Enoxaparin sodium injection.
Fourth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Incidence of asymptomatic deep vein thrombosis (DVT)
Time frame: Day 12.
Incidence of non-fatal pulmonary embolism (PE)
Time frame: Day 12.
Adverse events (AEs)
Time frame: Day 65.
Bleeding events
Time frame: Day 12.
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Enoxaparin sodium injection placebo.
SHR-2004 placebo in low dose.
SHR-2004 placebo in high dose.