In short
Clinical trials are investigating SRSD107 to see whether it can help prevent venous thromboembolism, a type of blood clot, after surgery. The main study is looking at safety and how well it works in people having elective total knee replacement, with comparison to enoxaparin.
Key points
- Clinical trials are studying SRSD107 for prevention of venous thromboembolism after knee surgery. The available trial is a Phase 2 interventional study in people having elective, primary, unilateral total knee arthroplasty. It compares SRSD107 with enoxaparin and also includes a sodium chloride injection control in the intervention list. The main goal is to measure total venous thromboembolism events, including deep vein thrombosis, pulmonary embolism, and unexplained death when PE cannot be excluded. The study plans to enroll 530 participants and is currently authorised.
Trial overview
The available study of SRSD107 is an interventional trial, which means researchers give a study treatment and then measure the results. It is designed to test whether SRSD107 can prevent venous thromboembolism events and to see how safe it is in this setting.
This study is in Phase 2, a stage that usually looks more closely at whether a treatment works while still watching safety. The trial is focused on people having planned knee replacement surgery on one knee.
Who can participate
The study is for subjects undergoing elective, primary, unilateral total knee arthroplasty (TKA). In simple words, this means people having a planned first-time total knee replacement on one knee.
The trial data do not provide more detailed entry rules, so the main known target group is patients in this surgery setting.
What is being measured
The main outcome is the incidence of total venous thromboembolism (VTE) events from the day of surgery through the venography visit. Incidence means how often the event happens in the study group.
VTE in this trial includes deep vein thrombosis (DVT), which may be silent and found by imaging, or may be symptomatic and confirmed by testing. It also includes pulmonary embolism (PE), both non-fatal and fatal cases, and unexplained death when PE cannot be ruled out.
The planned venography follow-up is 12±2 days after surgery. Venography is an imaging test used to look for clots in the veins.
Study design and comparators
The trial compares SRSD107 with enoxaparin, which is listed in the study data as Clexane 40 mg given under the skin. The intervention list also includes 0.9% sodium chloride solution for injection.
Because the study is interventional, the researchers are directly testing the study treatment against a comparison treatment to judge prevention of clot events after surgery.
Trial status and size
The trial status is Authorised. The planned enrollment is 530 participants, which means up to 530 people are expected to join the study.
At this time, the available source data describe one Phase 2 study of SRSD107 in the knee surgery setting.
Patient terms to know
- Venous thromboembolism means a blood clot in a vein. In this study, it is the main problem researchers want to prevent.
- Deep vein thrombosis is a clot in a deep vein, often in the leg. It can be found even when there are no symptoms.
- Pulmonary embolism is a clot that reaches the lungs. The study counts both non-fatal and fatal cases.
- Total knee arthroplasty means total knee replacement. The study is for people having this planned operation on one knee.
- Venography is a scan used to check the veins for clots. In this trial, it is done about 12 days after surgery.
- Comparator means the treatment used for comparison. Here, SRSD107 is compared with enoxaparin.