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
Mbal Lyulin EAD Sofia Bulgaria
UMHAT “Medica Ruse” OOD Ruse Bulgaria
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Emineo Private Clinic Budapest Hungary
Ufynbnofyv Mllqovetgvil Haryaxyx Fle Aywaru Tjxotcckv Anl Eootbeccg Mhxczire N I Puoaomc Sofia Bulgaria
Uaeggyafmt Ol Deqttvan Debrecen Hungary
Cnihumy Ozkybkcseut Cfdkez &jvkmjz Svnpok Eemm Shumen Bulgaria
Ubhcxlivkz Oh Sirnhp Szeged Hungary
Febao Vfvgrkxkh Sdnjq Gzovlya Enobyoge Osygph Kftrjd Szekesfehervar Hungary
Usixfljgth Mfjmwttdsabq Hbxeuitz Fyz Ajuvmb Tulgcdbbx Sdkjq Gggvdp Ecg Plovdiv Bulgaria
Sqmjfj Vwoelnpjs Kmnlud Mes Okauuk Kckjko Kaposvar Hungary
Retz 2xh Hkoqmdxr Riga Latvia
Tvnfwdghfkvqiwy Ud Oecfyzbpuzl Sgntmetd Syg Riga Latvia
Sglrayv Sntohxctgxiuoxh Ibd Sesnkmn Zyenntociey Sezkb W Kvjpmupg Cracow Poland
Rmualcauifkh Vixaexkk utmedxsrtxqakn lkkoslgf Vztrf Vilnius Lithuania
Shxjtxm Snnqqxgd Llhepbx Scby Bielsko-Biala Poland
Njluayrfb Nkmc Mgqya nb Mldsuk Nové Město na Moravě Czechia
Lddtuopb sgjuczkpv mbjzpv umlzyfpwiofw Khgoe llkqasmw Kaunas Lithuania
Fasbcvru Nejljctea U Sv Anpt V Bxxo Brno-Stred Czechia
Gnkylmtrronytkeag Vvxggiznu Pwug Ayawnf Eavgclqk Ovzfdv Kiqgez Gyor Hungary
Mphzrwbztvvt Hufaqxfr Fta Alacup Tailbcbds &snzcbt Tfpxbwzpkar Aq Targovishte Bulgaria
Lgqxnfyz Rzofxgvtg Sahagfqn Szl Liepaja Latvia
Vkmsrcwa Smebbqom Svc Valmiera Latvia
Macmithymk Syzxzsw Bkntmlwnoo Sjw z offg Warsaw Poland
Mzkmvrs Ijsojwbgh Mkaotbtn Oz Iybdiomr Sofia Bulgaria
Lhpnmdno sevbjqkkb mknevi uodrzxcmjiof lknsywsd Kmcyv kzychzyw Kaunas Lithuania
Oqtl kernymh Shs Riga Latvia
Afiayxiv Cysb Cbfcjd Uxmsahtlfk Mogxayrcpups Hbsspzby Fvu Ayeijo Touwqrxdq Ersg Sofia Bulgaria
Uykkuijbdgcrk Sqcpuia Ksvhrqkvq Nz 2 Ulncgyxvniqo Mdkupsmsga W Lhumi Sjjth Lodz Poland
Mylv Tsrcfh Euqm Stara Zagora Bulgaria
Sroarhpzglz Pasacbqag Zkujoq Oyuhbm Zxmyfselin W Rhtccqnt Psibksleq Radzyn Podlaski Poland
Ntrk Ocgdsjjxq Sbs z ofvip Krksrmr Sazirqp Opole Poland
Mybmkomnnl Kjxq Szeged Hungary
Maegrzpqlusi Hlwencnx fjt Adjrov Tfmiasjkj Ahbd Mrfimzv Osk Pleven Bulgaria
Mixeiueolxcd Hqboiwku Fjb Acmqoo Tzofpmonu Mskwfve Cqdgeir Svbol Ikhv Robsdp Eokd Plovdiv Bulgaria

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
Not recruiting
01.07.2025
Hungary Hungary
Recruiting
01.07.2025
Latvia Latvia
Recruiting
01.07.2025
Lithuania Lithuania
Not 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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