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Completed
NCT06825416
A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
Conditions: Prevention of Arterial and Venous Thrombosis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1165
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Location: Fourth Medical Center of Chinese People's Liberation Army General Hospital Beijing Beijing Municipality
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing;
2. Planned elective schedule total knee arthroplasty (TKA) patients;
3. Men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form.
Exclusion Criteria:
1. Unable to receive CT angiography of both lower limbs;
2. Malignant tumor within one year of the screening;
3. Myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening;
4. Any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding;
5. History of drug abuse;
6. Pregnant or lactating women.
Source: ClinicalTrials.gov (NCT06825416). StuddyBuddy aggregates publicly available trial information.
