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Study on Preventing Blood Clots in Pancreatic Cancer Patients Using Tinzaparin Sodium and Enoxaparin Sodium During Treatment

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What is this trial about?

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

This clinical trial focuses on patients with pancreatic cancer who are undergoing treatments before surgery, known as neoadjuvant treatments. The study aims to explore the effects of preventing blood clots, a condition known as thrombosis, which is a common risk for these patients. Two medications are being studied for their ability to prevent these clots: tinzaparin sodium, marketed as innohep®, and enoxaparin sodium, marketed as Inhixa. Both medications are given as a solution for injection under the skin.

The purpose of the study is to understand how these medications might reduce the risk of blood clots and improve the overall outlook for patients with pancreatic cancer. Participants will receive one of the medications or a placebo during their neoadjuvant treatment. The study will monitor the occurrence of blood clots, any bleeding complications, and the progression of the disease. Patients will be followed for at least five years or until they pass away.

Throughout the study, blood samples will be collected at various times to observe changes in blood clotting activity. These samples will be taken before starting neoadjuvant treatments, between chemotherapy cycles, after these treatments, and at several intervals during the follow-up period. This research hopes to provide valuable insights into the prevention of blood clots in pancreatic cancer patients and its potential impact on their survival and quality of life.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study focuses on the prevention of blood clots during treatments for pancreatic cancer.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather baseline information. This includes taking blood samples to measure your blood's clotting activity before starting any treatment.

  3. Step 3

    Medication administration

    You will receive **tinzaparin sodium** or **enoxaparin sodium** as a **subcutaneous injection**. This means the medication will be injected under your skin. The specific dosage and frequency will be determined by the study team based on your individual needs.

  4. Step 4

    Neoadjuvant treatment phase

    During the neoadjuvant treatment phase, which is the period before any potential surgery, you will continue to receive the injections. Blood samples will be taken at various points: before starting treatment, between chemotherapy cycles, and after completing the neoadjuvant treatments.

  5. Step 5

    Follow-up assessments

    Follow-up assessments will occur at months 1, 3, 6, 12, 15, 24, and 36. These assessments will include blood tests to monitor changes in your blood's clotting activity and to check for any progression of the disease.

  6. Step 6

    Long-term monitoring

    You will be monitored for at least five years or until the end of the study. This monitoring will include checking for any blood clotting events, bleeding complications, and changes in your health status.

Who can join the trial?

3 criteria

  • The patient must be an adult with pancreatic cancer.
  • The patient should be planning to receive neoadjuvant treatments, which are therapies given before the main treatment to shrink a tumor.
  • Both men and women can participate in the study.

Who cannot join the trial?

6 criteria

  • Patients who are not receiving neoadjuvant treatments for pancreatic cancer cannot participate. (Neoadjuvant treatments are therapies given before the main treatment to shrink a tumor.)
  • Patients who are not at increased risk of thrombosis cannot participate. (Thrombosis is the formation of a blood clot inside a blood vessel.)
  • Patients who are not suitable for thromboprophylaxis cannot participate. (Thromboprophylaxis is a treatment to prevent blood clots.)
  • Patients who are not part of the specified age range cannot participate. (The age range is not specified here, but it is important for eligibility.)
  • Patients who are not part of the specified clinical trial group cannot participate. (The specific group is not detailed here, but it is important for eligibility.)
  • Patients who are part of a vulnerable population cannot participate. (Vulnerable populations may include groups like children, pregnant women, or those unable to consent.)
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Investigated drugs

Thromboprophylaxis is a treatment used to prevent blood clots from forming in the blood vessels. In this clinical trial, it is being used to help patients with pancreatic cancer who are undergoing neoadjuvant treatment, which is therapy given before the main treatment. The goal is to reduce the risk of developing blood clots, which can be a serious complication for these patients. By preventing these clots, the treatment aims to improve the overall health and survival chances of the patients.

What is already known about the treatment

Enhanced Thromboprophylaxis – This medication is administered to patients undergoing neoadjuvant treatments for pancreatic cancer to prevent blood clots. It is currently being studied in clinical trials to assess its effectiveness and safety in reducing the risk of thrombosis, which is a common complication in these patients. The main therapeutic indication is to prevent vascular events and improve survival prognosis in pancreatic cancer patients. At the molecular level, it works by inhibiting the formation of blood clots, although the specific mechanism can vary depending on the exact formulation used. It is classified pharmacologically as an anticoagulant, which means it helps to prevent the blood from clotting too easily.

Investigated diseases

Pancreatic Cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. It often begins in the cells that produce digestive juices or hormones. As the cancer progresses, it can invade nearby organs and spread to other parts of the body. The disease may cause symptoms such as jaundice, weight loss, and abdominal pain. It is known for its aggressive nature and tendency to spread quickly. The progression of pancreatic cancer can vary, but it often involves the growth of tumors and potential metastasis to other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512475-12-01Estimated enrolment214 patientsSponsorHUS-yhtymae

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