Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Cluster randomised trial of low molecular weight heparins - Directly through Epic

This study compares two types of blood-thinning medicines, Tinzaparin and Dalteparin, often used in hospitals to prevent or treat blood clots (venous thromboembolism). These medicines, called low molecular weight heparins, are commonly given by injection. The main goal is to find out if there's a difference between these two medicines in terms of serious bleeding that needs a blood transfusion, or death within 30 days. Researchers will also look at other things like death rates after a year, how long people stay in the hospital, and other possible side effects. This research helps doctors make the best choices for patient care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rigshospitalet

Enrolment target

65,000

Start

18 Jan 2023

Venous thromboembolism

What is this study about?

Imagine your body sometimes forms unwanted blood clots in your veins, which can be serious. Doctors often give special medicines, called blood thinners or anticoagulants, to prevent or treat these clots. This study is like a large-scale check-up on two common blood-thinning medicines, Tinzaparin and Dalteparin, that are given as injections while people are in the hospital. Both are types of medicine called 'low molecular weight heparins', which work by making your blood less likely to clot.

The main aim of this study is to compare these two medicines head-to-head. Researchers want to see if one is better or safer than the other. Specifically, they're looking for any differences in serious bleeding episodes that might require a blood transfusion, or in the number of deaths within 30 days of receiving the medicine. This is important information because bleeding is a known risk of blood thinners, and doctors always want to use the safest and most effective treatment.

Beyond the main goal, the study will also track other important health outcomes. This includes looking at death rates over a longer period (up to a year), how long people need to stay in the hospital, and other potential side effects or complications, such as new blood clots in the lungs. By gathering all this information, doctors can get a clearer picture of how these two widely used medicines compare in real-world hospital settings.

Key takeaways

This study compares two common blood-thinning medicines, Tinzaparin and Dalteparin.
It aims to see if one medicine is safer regarding serious bleeding or death within 30 days.
Participation involves researchers looking at your existing hospital records, not extra visits or treatments.
The findings will help doctors make better treatment choices for patients in the future.
This research focuses on medicines already in widespread use.

Who may be eligible?

This study is looking for a wide range of adults. To be considered, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also be included.

Both men and women can take part in this study. The researchers aim to include a diverse group of patients to make sure the results are useful for everyone.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you an inpatient in a hospital where these medicines might have been used?
Were you diagnosed with or at risk of blood clots?
Did you receive Tinzaparin or Dalteparin as part of your care?

Answer every question to see your result.

What does participation involve?

This study is a bit different because it uses information already gathered during your hospital stay. If you're included, you won't need extra visits or special assessments just for the study. The researchers will be looking at your medical records to see which of the two medicines you received (Tinzaparin or Dalteparin) as part of your usual care. They will then track your health outcomes, such as any bleeding, new blood clots, or how long you stayed in the hospital, for around 30 days after treatment, and in some cases, for up to a year. You won't be asked to take any additional medication or change your usual treatment plan.

Potential risks and benefits

Since this study largely uses information from your normal hospital care and doesn't involve extra procedures, there are no additional risks to your health from participating. The potential benefit is that the findings will help doctors choose the safest and most effective blood-thinning medicine for future patients. You always have the right to withdraw your information from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is a 'blood thinner'?

A blood thinner is a medicine that helps prevent blood clots from forming too easily in your body, or stops existing clots from getting bigger. They are often used for conditions like 'venous thromboembolism', which is a type of blood clot.

What does 'low molecular weight heparin' mean?

This is a specific type of blood thinner given by injection. Tinzaparin and Dalteparin are both in this group of medicines.

Will I have to do anything extra if I'm in this study?

No, you won't have any extra appointments, tests, or medicines. The researchers will use information from your regular care during your hospital stay.

What does 'major bleeding' mean in this study?

In this study, 'major bleeding' refers to any serious bleeding that is severe enough to require a blood transfusion, or contributes to death.

Is this study looking for a new medicine?

No, this study is looking at two existing, commonly used medicines. Researchers want to compare how well they work and how safe they are in a real-world setting.