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Study on Dalteparin Sodium and Enoxaparin Sodium for Preventing Blood Clots in Patients Undergoing Liver Surgery

Fast replyRegistered drugNo placebo
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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 liver surgery, specifically those having a part of their liver removed, known as liver resection. The study is investigating the use of two medications, dalteparin sodium and enoxaparin sodium, which are both used to prevent blood clots. These medications are given through a small injection under the skin, known as a subcutaneous injection. The purpose of the study is to determine if starting these medications before or after surgery is more effective in reducing the risk of blood clots without increasing the risk of bleeding complications.

Participants in the study will receive either dalteparin sodium or enoxaparin sodium, or a placebo, for a period of up to four weeks. The study will monitor the occurrence of blood clots, known as venous thromboembolisms, within 30 days after the liver surgery. Additionally, the study will look at other factors such as bleeding after surgery, the length of hospital stay, and the amount of blood transfusions needed.

The trial aims to provide valuable information on the best timing for starting blood clot prevention treatment in patients undergoing liver surgery. By comparing the effects of starting the medication before surgery versus after, the study hopes to improve patient outcomes and reduce complications associated with liver surgery.

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

    Joining the trial

    Participation begins after meeting the inclusion criteria, which require undergoing liver resection surgery.

  2. Step 2

    Preoperative phase

    Before surgery, the patient may receive a subcutaneous injection of either dalteparin sodium or enoxaparin sodium as part of thromboprophylaxis. This is to prevent blood clots.

  3. Step 3

    Surgery

    The patient undergoes liver resection surgery. This is the main procedure for which the trial is conducted.

  4. Step 4

    Postoperative phase

    After surgery, the patient continues to receive subcutaneous injections of either dalteparin sodium or enoxaparin sodium to prevent blood clots. The duration and frequency of these injections are determined by the trial protocol.

  5. Step 5

    Monitoring and follow-up

    The patient is monitored for 30 days after surgery for any venous thromboembolisms, which are blood clots in the veins.

    Other factors monitored include any bleeding complications, the length of hospital stay, and the amount of blood transfused during and after surgery.

Who can join the trial?

5 criteria

  • Patients must be undergoing **liver surgery**. This means they are having an operation on their liver.
  • Patients must be having a **liver resection**. This is a type of surgery where a part of the liver is removed.
  • Patients can be of any gender, meaning both males and females can participate.
  • Patients must be within certain age ranges, specifically between 18 and 64 years old.
  • Patients should not be part of a vulnerable population. This means they should not be in a group that is considered at higher risk for harm or exploitation.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing liver surgery cannot participate. Liver surgery refers to any surgical procedure performed on the liver.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Thromboprophylaxis Medication is used to prevent blood clots in patients undergoing liver resection surgery. This medication helps reduce the risk of venous thromboembolism, which is a condition where blood clots form in the veins. The goal is to start this medication around the time of surgery to protect patients from developing these potentially dangerous clots without increasing the risk of bleeding.

What is already known about the treatment

Thromboprophylaxis Medication – This medication is administered to patients undergoing liver surgery to prevent blood clots. It is typically given as an injection, either before or after the surgical procedure. Currently, it is being studied in clinical trials to determine its effectiveness in reducing the risk of venous thromboembolism without increasing bleeding complications. The medication works by inhibiting certain factors in the blood that are responsible for clot formation. It is classified as an anticoagulant, which means it helps to prevent the formation of harmful blood clots.

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 the lungs or 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. Symptoms may include swelling, pain, and redness in the affected area, as well as difficulty breathing if the lungs are involved. The condition can develop after surgery, prolonged immobility, or due to certain medical conditions. Early detection and management are crucial to prevent further complications.

  • Posthepatectomy Hemorrhage

    This condition refers to bleeding that occurs after liver surgery, which can vary in severity. It may happen immediately after the operation or within a few days. The bleeding can be due to surgical complications or issues with blood clotting. Symptoms might include a drop in blood pressure, increased heart rate, and signs of blood loss such as pallor or fatigue. Monitoring and managing blood loss are important to ensure recovery. The condition is assessed using specific classifications to determine its severity and impact on the patient.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519726-20-00Protocol codePREPOSTEROUSEstimated enrolment500 patientsSponsorOslo University Hospital HF

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