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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.)

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Oulu University Hospital	Oulu	Finland
Turku University Hospital	Turku	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Hdvgligl Uxvsxphvis Ckmkprx Hzxtxxpu	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.01.2025

Trial locations

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.

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 ID:

2024-512475-12-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?