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Study on Venous Thromboembolism Prevention with Enoxaparin Sodium and Drug Combination for Patients Undergoing Total Hip or Knee Replacement

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What is this trial about?

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

This clinical trial is focused on studying the prevention of venous thromboembolism (VTE), a condition where blood clots form in the veins, in patients undergoing total hip or knee replacement surgery. The study will compare different approaches to preventing these clots, including a personalized method versus the standard approach. The trial aims to determine the effectiveness and safety of these methods in patients with varying levels of risk for developing VTE.

The trial will involve several medications, including Enoxaparin Sodium, Dabigatran, Nadroparin Calcium, Apixaban, Dalteparin Sodium, Rivaroxaban, Andexanet Alfa, and a combination product containing Human Coagulation Factors. These medications are known as anticoagulants, which help prevent blood clots. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

Participants in the study will be monitored for three months after their surgery to track the occurrence of VTE and any major bleeding events. The study will also look at other health outcomes, such as heart attacks, strokes, and infections related to the joint replacement. The goal is to find the best way to prevent blood clots while ensuring patient safety during and after surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation begins with an initial assessment to confirm eligibility. This includes verifying that the individual is scheduled for an elective total hip or knee replacement and is 18 years or older.
Step 2
Randomization
Participants are randomly assigned to one of the study groups. Each group receives a different approach to prevent blood clots, known as venous thromboembolism (VTE), after surgery.
Step 3
Medication administration
Depending on the assigned group, participants receive specific medications to prevent VTE. These medications include enoxaparin sodium and nadroparin calcium administered via subcutaneous injection, and apixaban and rivaroxaban taken orally.
In some cases, andexanet alfa or a combination of human coagulation factors may be administered through infusion.
Step 4
Hospital stay
During the hospital stay, participants receive thrombosis prophylaxis as per their assigned group. The effectiveness of in-hospital thrombosis prophylaxis is evaluated, especially for those with low VTE risk.
Step 5
Postoperative period
For the first three months after surgery, the number of VTE events and major bleeding incidents are monitored. Participants may receive intensified thrombosis prophylaxis if they are at high risk for VTE.
Step 6
Follow-up assessments
Regular follow-up assessments are conducted to monitor for any clinically relevant non-major bleeding, prosthetic joint infections, and other health outcomes such as heart attack, stroke, or death.
The impact of these events on quality of life and healthcare costs is also evaluated.

Who can join the trial?

4 criteria

Patients must be scheduled to have a planned surgery for a Total Hip Replacement or Total Knee Replacement. These are surgeries to replace a hip or knee joint with an artificial one.
Patients must be 18 years old or older.
Both men and women can participate.
Patients should not be part of a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who cannot join the trial?

4 criteria

Patients who have a history of **venous thromboembolism** (VTE), which is a condition where blood clots form in the veins.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are considered part of a vulnerable population, meaning they may have additional health or social factors that require special consideration.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gelre Hospitals
Verified
Zutphen, The Netherlands
Isala Klinieken Stichting
Verified
Zwolle, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

Thrombosis Prophylaxis Therapy is used to prevent blood clots in patients undergoing total hip or knee replacement surgery. This therapy aims to reduce the risk of developing venous thromboembolism (VTE), which includes conditions like deep vein thrombosis and pulmonary embolism. The trial is investigating whether a personalized approach to thrombosis prevention is as effective as the standard method, which is typically the same for all patients. The therapy may involve medications that help prevent blood clots by thinning the blood or other methods to reduce clotting risk.

What is already known about the treatment

Rivaroxaban – Rivaroxaban is an oral medication taken in tablet form, primarily used to prevent and treat blood clots, such as venous thromboembolism (VTE). It is well-established in medical literature as an effective anticoagulant, often prescribed for patients undergoing surgeries like total hip or knee replacement. The drug works by inhibiting Factor Xa, an essential protein in the blood clotting process, thereby reducing the risk of clot formation. Rivaroxaban belongs to the pharmacological class of direct oral anticoagulants (DOACs), offering a targeted approach to managing clot-related conditions.

Investigated diseases

Venous thromboembolism – This condition involves the formation of blood clots in the veins, which can lead to complications if the clots travel to other parts of the body. It typically begins with a clot forming in a deep vein, often in the legs, known as deep vein thrombosis. If the clot dislodges, it can travel to the lungs, causing a pulmonary embolism, which can affect breathing and circulation. Symptoms may include swelling, pain, and redness in the affected area, as well as shortness of breath and chest pain if the lungs are involved. The risk of developing venous thromboembolism can increase after surgery, particularly procedures involving the legs or hips. Prevention strategies often focus on reducing the risk of clot formation during and after surgery.