Not recruiting

Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism

Registered 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 studying the effects of blood thinners, specifically low molecular weight heparins, in patients with a condition known as venous thromboembolism. This condition involves the formation of blood clots in the veins, which can be dangerous if not treated properly. The trial will compare two medications: TINZAPARIN and DALTEPARIN. Both of these medications are types of blood thinners that help prevent the formation of clots by making the blood less likely to clot.

The purpose of the study is to evaluate whether treatment with these blood thinners affects the risk of bleeding that requires medical attention or leads to death within 30 days of starting the treatment. Participants in the study will receive either TINZAPARIN or DALTEPARIN through a subcutaneous injection, which means the medication is injected under the skin. The study will monitor patients over a period of time to observe any major bleeding events or other health outcomes.

Throughout the study, researchers will track various health indicators, such as the need for blood transfusions, the occurrence of pulmonary embolism (a blockage in the lung's blood vessels), and any signs of heparin-induced thrombocytopenia (a condition where the blood has a lower than normal number of platelets). The study will also look at overall survival rates and the length of hospital stays. This information will help determine the safety and effectiveness of these blood thinners in treating patients with venous thromboembolism.

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 admission to the hospital, you may be considered for participation in the study if you have a condition that requires treatment with a low molecular weight heparin.
This is a type of medication used to prevent blood clots, known as venous thromboembolism.
Step 2
Randomization
You will be randomly assigned to receive one of two medications: tinzaparin or dalteparin.
Both medications are administered through a subcutaneous injection, which means they are injected under the skin.
Step 3
Medication administration
The dosage and frequency of the medication will be determined by the healthcare team based on your specific needs.
The treatment will continue throughout your hospital stay, and the healthcare team will monitor your response to the medication.
Step 4
Monitoring and follow-up
During the study, you will be monitored for any signs of major bleeding or other side effects.
The primary focus is to observe if there is any major bleeding requiring a blood transfusion or any other significant health changes within 30 days.
Step 5
End of study participation
Your participation in the study will conclude 30 days after the start of the treatment.
The healthcare team will continue to monitor your health status and any potential side effects during this period.

Who can join the trial?

6 criteria

Patients must be admitted to the hospital.
Patients must have a medical need for treatment with a low molecular weight heparin (a type of medication used to prevent blood clots).
Patients will only be included the first time they are admitted during the study period.
Both male and female patients can participate.
Patients of all age groups are eligible.
The study includes patients who may be considered part of a vulnerable population (groups that may need special protection or care).

Who cannot join the trial?

9 criteria

Patients who have a history of **bleeding disorders**. This means any condition that makes it hard for the blood to clot properly.
Patients who are currently taking other **anticoagulant medications**. These are drugs that help prevent blood clots.
Patients with **severe liver or kidney disease**. This refers to serious problems with the liver or kidneys that affect their normal function.
Patients who are pregnant or breastfeeding.
Patients who have had a recent **surgery**. This means any major operation that was done recently.
Patients with a known allergy to **heparin** or similar medications. Heparin is a type of medication used to prevent blood clots.
Patients who have **uncontrolled high blood pressure**. This means blood pressure that is not being managed well with treatment.
Patients with a history of **stroke**. A stroke is a medical condition where poor blood flow to the brain results in cell death.
Patients who have **active cancer**. This refers to cancer that is currently being treated or is not in remission.

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Investigated drugs

Low Molecular Weight Heparins are a type of medication used to prevent and treat blood clots. They work by thinning the blood, which helps to stop clots from forming or growing larger. In this clinical trial, the focus is on understanding if using any of these medications might increase the risk of bleeding that requires medical attention or could lead to death within 30 days for patients who need this type of treatment. These medications are often used in hospitals for patients who are at risk of developing blood clots, such as those who are bedridden or have certain medical conditions.

What is already known about the treatment

Low Molecular Weight Heparins – These medications are typically administered through an injection under the skin. They are currently well-established in medical practice and literature, primarily used to prevent and treat blood clots, such as those occurring in venous thromboembolism. The main therapeutic use is to reduce the risk of blood clots forming in the veins. At the molecular level, they work by enhancing the activity of a natural protein in the body that helps prevent clotting, thereby reducing the blood's ability to form clots. They belong to the pharmacological class of anticoagulants, which are substances that help prevent blood clots.

Investigated diseases

Venous thromboembolism – Venous thromboembolism is a condition where blood clots form in the veins, typically in the legs, known as deep vein thrombosis. These clots can break loose and travel to the lungs, causing a pulmonary embolism, which can block blood flow. The condition often begins with swelling, pain, and redness in the affected area. As it progresses, it can lead to more severe symptoms like difficulty breathing, chest pain, and rapid heart rate if a clot reaches the lungs. The risk of developing venous thromboembolism increases with factors such as prolonged immobility, surgery, or certain medical conditions. It is important to monitor for symptoms and seek medical attention if they occur.