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Study on Apixaban for Preventing Blood Clots in Patients Undergoing Abdominal, Gynecologic, and Urologic Surgery

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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 patients undergoing general abdominal, gynecologic, and urologic surgeries. The study is investigating the use of a medication called apixaban, which is an anticoagulant. Anticoagulants are medicines that help prevent blood clots. The trial aims to understand the benefits and risks of using apixaban to prevent blood clots, known as venous thromboembolism (VTE), in patients who are at a similar risk of developing these clots and experiencing bleeding during or after surgery.

Participants in the study will be randomly assigned to receive either apixaban or no anticoagulant treatment. Both groups will receive standard care, which includes mechanical methods to prevent blood clots, such as compression stockings. The study will monitor the occurrence of blood clots and any bleeding complications over a period of 90 days after surgery. The goal is to determine if apixaban provides a net benefit in preventing blood clots without causing significant bleeding.

The trial will also assess the safety of apixaban by tracking any major bleeding events, which could include a significant drop in hemoglobin levels, the need for blood transfusions, or bleeding that requires additional medical intervention. The study will help to clarify whether using apixaban is a safe and effective option for patients undergoing these types of surgeries.

The research process

The trial runs in 5 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, informed consent is required. This means understanding the study's purpose and agreeing to participate.
Eligibility includes being an adult aged 18 or older and undergoing abdominal or pelvic surgery with a similar risk of blood clots and bleeding.
Step 2
Medication administration
The study involves the use of apixaban, an oral medication that helps prevent blood clots. It is taken by mouth.
The dosage and frequency of apixaban will be determined by the study protocol and communicated to you by the study team.
Step 3
Surgery and monitoring
During the surgery, standard care for preventing blood clots will be provided, which may include mechanical methods.
After surgery, monitoring for any signs of blood clots or bleeding will occur. This includes checking for symptoms of deep vein thrombosis (DVT) or pulmonary embolism (PE).
Step 4
Follow-up period
The follow-up period lasts for 90 days after surgery. During this time, the incidence of blood clots and bleeding will be assessed.
Regular check-ins may be required to monitor your health and any potential side effects of the medication.
Step 5
Outcome assessment
The primary outcome is the occurrence of blood clots, such as DVT or PE, within 90 days.
Secondary outcomes include the incidence of major bleeding and other health events related to the study medication.

Who can join the trial?

5 criteria

The patient must provide informed consent, which means they agree to participate in the study after understanding all the details and risks involved.
The patient must be an adult, which means they are 18 years old or older at the time of screening.
The patient must be undergoing abdominal or pelvic surgery. This includes surgeries in the belly or lower part of the body.
The patient should be at a similar (and not high) risk of developing blood clots (known as venous thromboembolism or VTE) and bleeding. This means their risk level is not too high, making it safe to consider the study treatment.
Both male and female patients can participate in the study.

Who cannot join the trial?

5 criteria

Patients who are at a high risk of **bleeding**. This means there is a greater chance of losing a lot of blood during or after surgery.
Patients who are at a high risk of **venous thromboembolism (VTE)**. This is a condition where blood clots form in the veins, which can be dangerous.
Patients who are not undergoing **urologic, gynecologic, or general abdominal surgery**. These are specific types of surgeries related to the urinary system, female reproductive system, and the abdomen.
Patients who are not within the specified **age range** for the study. The study is looking for participants within certain age groups.
Patients who belong to a **vulnerable population**. This refers to groups of people who might need special protection or care.

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Verified sites

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

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Helsinki University Central Hospital
Helsinki, Finland
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Oulu University Hospital
Oulu, Finland
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Pirkanmaan hyvinvointialue
Tampere, Finland

Trial locations

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Investigated drugs

Apixaban is a medication used in this trial to prevent blood clots in patients undergoing surgery. It is an oral anticoagulant that works by inhibiting a specific factor in the blood clotting process, helping to reduce the risk of thrombosis. In this study, it is being compared to not using any anticoagulant to see if it provides benefits in preventing blood clots without increasing the risk of bleeding.

Apixaban

What is already known about the treatment

Apixaban – Apixaban is an oral medication administered in tablet form, primarily used to prevent blood clots in patients undergoing certain types of surgery, such as abdominal, gynecologic, and urologic procedures. It is currently being evaluated in clinical trials to determine its effectiveness and safety compared to not using anticoagulation therapy. The main therapeutic indication for apixaban is the prevention of venous thromboembolism in surgical patients. At the molecular level, apixaban works by inhibiting factor Xa, an essential component in the blood clotting process, thereby reducing the risk of clot formation. It is classified as a direct oral anticoagulant (DOAC).

Investigated diseases

Venous Thromboembolism – This condition involves the formation of blood clots in the veins, typically in the legs, known as deep vein thrombosis (DVT). If a clot breaks loose, it can travel to the lungs, causing a pulmonary embolism (PE). In surgical patients, the risk of developing venous thromboembolism increases due to factors like immobility and tissue damage. The condition can manifest with symptoms such as swelling, pain, and redness in the affected area. Pulmonary embolism may present with shortness of breath, chest pain, and coughing. The progression of venous thromboembolism can vary, with some cases resolving on their own while others may lead to complications.