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

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What is this study about?

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.

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 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 Surgery

You will undergo planned knee replacement surgery.

The surgery will be performed under general anesthesia.

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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Mbal Lyulin EAD Sofia Bulgaria
Orto klinika SIA Riga Latvia
Samodzileny Publiczny Zaklad Opieki Zdrowotnej W Radzyniu Podlaskim Radzyn Podlaski Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
University Of Debrecen Debrecen Hungary
Respublikine Vilniaus universitetine ligonine VšĮ Vilnius Lithuania
Lietuvos sveikatos mokslu universiteto Kauno ligonine Kaunas Lithuania
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
Liepajas Regionala Slimnica SIA Liepaja Latvia
Vidzemes Slimnica SIA Valmiera Latvia
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
University Of Szeged Szeged Hungary
Nvgwnpjgw Nndz Mlepl nj Mbjgjh Nové Město na Moravě Czechia
Tkjyktzmhqxktvz Ut Otowfnpapnn Sabnewbm Sff Riga Latvia
Rykw 2ux Hrrfjpqo Riga Latvia
Ggztggocohgdeeuvr Vmvfrhgai Pewh Afjlxr Ezaqotsm Odphfk Kntfta Gyor Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
01.07.2025
Czechia Czechia
Recruiting
01.07.2025
Hungary Hungary
Recruiting
01.07.2025
Latvia Latvia
Recruiting
01.07.2025
Lithuania Lithuania
Recruiting
01.07.2025
Poland Poland
Recruiting
01.07.2025

Trial locations

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.

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 ID:
2024-519688-16-00
Protocol code:
SRSD107-201
Trial Phase:
Therapeutic exploratory (Phase II)

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