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Comparison of SRSD107 and enoxaparin to prevent blood clots in adults undergoing knee replacement surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on preventing venous thromboembolism (blood clots in veins) in patients who are having total knee arthroplasty (knee replacement surgery). The study will test a new medication called SRSD107, which is given as an injection under the skin, comparing it to another blood-thinning medication called enoxaparin.

The purpose of this research is to determine how well different doses of SRSD107 work in preventing blood clots compared to enoxaparin in people having knee replacement surgery. During the study, participants will receive either SRSD107 or enoxaparin as injections under the skin. Some participants will also receive sodium chloride solution injections.

The study will monitor participants before their surgery and continue following them for several months afterward. Doctors will check for any signs of blood clots and assess if the medications are working safely. They will use special imaging tests to look for blood clots in the leg that received surgery. The study will also track any bleeding or other health issues that might occur during the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and qualification

    Your eligibility for the study will be verified based on specific criteria, including age (60-85 years), body mass index (18.0-35.0 kg/m²), and blood test results.

    Standard blood tests will be performed to check your blood clotting parameters.

    You must be scheduled for total knee arthroplasty (knee replacement surgery) under general anesthesia.

  2. Step 2

    Pre-surgical medication period

    You will receive study medication at least 28 days before your knee surgery.

    The medication will be either SRSD107 or enoxaparin, administered through subcutaneous injection (under the skin).

  3. Step 3

    Surgery

    You will undergo planned knee replacement surgery.

    The surgery will be performed under general anesthesia.

  4. Step 4

    Post-surgical monitoring

    A special X-ray examination called venography will be performed 12 days (plus or minus 2 days) after your surgery.

    This examination will check for potential blood clots in the operated leg.

  5. Step 5

    Follow-up period

    You will be monitored for any side effects or complications up to day 64 after surgery.

    A final assessment will be conducted on day 169.

    During this period, doctors will monitor for any bleeding events or blood clot formation.

Who can join the trial?

8 criteria

  • Must be able to give written permission (informed consent) before any study procedures begin
  • Must be between 60 and 85 years old, can be male or female of any race
  • Female participants must not be able to become pregnant (not of childbearing potential)
  • Must have a body mass index (BMI) between 18.0 and 35.0 kg/m² (BMI is a measure of body fat based on height and weight)
  • Must be scheduled for elective primary unilateral total knee replacement surgery (first-time knee replacement on one knee) under general anesthesia
  • Must be willing to: - Take study medication for at least 28 days before knee surgery - Attend clinic visits - Have an X-ray of veins (venography) 10-14 days after surgery
  • Must have normal blood clotting test results at screening: - aPTT (activated partial thromboplastin time) - PT (prothrombin time) - INR (international normalized ratio)
  • Male participants must agree to use birth control during the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Current pregnancy or breastfeeding
  • History of blood clotting disorders (conditions that affect how blood forms clots)
  • Active bleeding or high risk of bleeding
  • Severe liver disease
  • Severe kidney disease
  • History of stroke in the past 6 months
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • Major surgery in the past month (excluding the planned knee surgery)
  • Current use of blood-thinning medications (such as warfarin)
  • Known allergic reactions to similar medications
  • Active cancer requiring treatment
  • Severe heart disease
  • Body weight below 40 kg (88 pounds)
  • Participation in another clinical trial in the past 30 days
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Investigated drugs

  • SRSD107

    is an investigational medication being studied for preventing blood clots in patients who undergo knee replacement surgery. It is being tested as a potential alternative to currently available blood thinners.

  • Enoxaparin

    is a commonly used blood-thinning medication that helps prevent blood clots from forming. It is often given to patients after surgery to reduce the risk of developing dangerous blood clots in the legs or lungs. It belongs to a class of medications called low molecular weight heparins.

What is already known about the treatment

  • Enoxaparin

    A low molecular weight heparin medication administered through subcutaneous injection, commonly used to prevent and treat blood clots, particularly venous thromboembolism. This anticoagulant works by binding to antithrombin III, enhancing its ability to inhibit blood-clotting factors Xa and IIa, thus preventing blood clot formation. It is frequently prescribed for patients undergoing orthopedic surgeries, such as knee replacements, and has been established as a standard treatment in medical practice with extensive clinical evidence supporting its safety and efficacy.

  • SRSD107

    An investigational anticoagulant medication being studied as a potential alternative to enoxaparin for preventing blood clots in patients undergoing total knee arthroplasty. This drug is currently undergoing clinical trials to evaluate its efficacy and safety profile compared to standard enoxaparin treatment in preventing venous thromboembolism following knee replacement surgery. The exact mechanism of action and administration details are still under investigation through clinical research.

Investigated diseases

  • Venous thromboembolism (VTE)

    A condition where blood clots form in the veins, most commonly in the deep veins of the legs (deep vein thrombosis). These clots can break free and travel through the bloodstream to the lungs, where they can lodge in the pulmonary arteries. The condition often develops during periods of reduced mobility or after surgery. VTE can occur without any noticeable symptoms, though some people may experience leg pain, swelling, or warmth in the affected area. The condition can develop gradually or suddenly, and it's more common in adults, particularly those over 60.

  • Deep vein thrombosis (DVT)

    A medical condition that occurs when a blood clot forms in one or more of the deep veins in the body, most commonly in the legs. The clots typically form when blood flow slows down or changes, such as during long periods of inactivity or after surgery. DVT can cause leg pain, swelling, and warmth in the affected area, though it can also occur without any symptoms. The condition is more likely to develop after major surgery, especially orthopedic procedures like knee replacement.

  • Pulmonary embolism (PE)

    A blockage in one or more arteries in the lungs, typically caused by blood clots that travel from deep veins elsewhere in the body. The condition develops when a clot breaks free and moves through the bloodstream to the lungs. PE can cause difficulty breathing, chest pain, and rapid heartbeat. The condition can develop suddenly and may occur alongside or following deep vein thrombosis.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519688-16-00Protocol codeSRSD107-201Estimated enrolment456 patientsSponsorSirius Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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