All studies
AuthorisedTherapeutic use (Phase IV)Interventional

PERCUTANEOUS EMBOLECTOMY, LOW DOSE THROMBOLYSIS OR HEPARIN FOR INTERMEDIATE HIGH RISK PULMONARY EMBOLISM

This research is investigating the best treatments for a specific type of blood clot in the lungs called an 'intermediate-high risk pulmonary embolism' (PE). We compare two ways of dealing with the clot directly – either using special medicines to dissolve it (low-dose thrombolysis) or removing it with a small procedure called embolectomy – against the usual treatment with blood-thinning medicines (heparin or tinzaparin). The main aim is to see if these direct methods can reduce the clot's size and improve blood flow in the lungs more effectively than standard blood thinners. We also want to understand if they lead to fewer complications, better recovery, and improved quality of life for patients. This study is for adults aged 18 and over, both men and women.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Rigshospitalet
Enrolment target
210
Start
18 Oct 2024

What is this study about?

This study is about helping people who have a specific kind of blood clot in their lungs. These clots are called 'pulmonary embolisms' (PE), and in this study, we're focusing on those considered 'intermediate-high risk'. This means the clot is significant enough to cause concern, but not immediately life-threatening in the way some very large clots can be. We want to find the safest and most effective way to treat these clots.

Currently, the standard treatment often involves medicines called blood thinners, like heparin or tinzaparin, which stop the clot from growing and help your body break it down over time. However, this study is exploring two other approaches: using a small amount of strong clot-dissolving medicine (Actilyse), or using a special procedure called embolectomy to physically remove part of the clot. Sometimes the embolectomy procedure might also use sound waves (USAT) to help break up the clot.

The main goal is to see if using these more direct methods – dissolving the clot or removing it – can reduce the size of the clot and improve blood flow in the lungs more quickly or effectively than just using blood thinners. We'll be carefully comparing how well people recover, looking at things like hospital stay, breathing difficulties, and overall quality of life, while also keeping a close eye on any potential side effects from the treatments.

Key takeaways

  • This study compares different treatments for a type of lung clot.
  • It evaluates blood thinners against clot-dissolving medicine or clot removal procedure.
  • The aim is to find safer and more effective ways to treat these clots.
  • Researchers will check clot size, breathing, and quality of life.
  • Study participants will be followed for at least 3 months.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There is no upper age limit for taking part.

To be considered for this study, you would need to have been diagnosed with an 'intermediate-high risk pulmonary embolism'. Your doctor will be able to tell you if this description applies to your situation.

There might be other specific health conditions or medications that would mean you couldn't join, to ensure your safety. Your doctor will carefully check all these details to see if this study is suitable for you.

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.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with a pulmonary embolism?
  3. Has your doctor told you your pulmonary embolism is 'intermediate-high risk'?
  4. Are you prepared to attend follow-up appointments for at least 3 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the specific treatment you receive will be chosen by your medical team. You might receive blood-thinning medication (like heparin or tinzaparin), a low dose of clot-dissolving medicine (Actilyse), or undergo a procedure to remove the clot (embolectomy, possibly with sound waves). Your hospital stay will be monitored closely.

After your initial treatment, there will be follow-up appointments. This will involve checking for any bleeding complications and assessing how well your breathing has improved, typically 48-96 hours after treatment and again after 3 months. We will also check your heart with an ultrasound scan (echocardiography) and assess your ability to walk for six minutes to see how your fitness has progressed. You'll also complete questionnaires about your quality of life. The full duration of your participation will involve the initial treatment period and then follow-up for at least 3 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit is that you might receive a treatment that could help you recover better or more quickly from your blood clot compared to standard care. However, there's no guarantee this will be the case. Potential risks might include side effects from the medications, such as bleeding, which will be closely monitored. Procedures carry their own small risks, which your doctor will explain in detail. Importantly, you are always free to change your mind and withdraw 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.
  • Unverified
    Denmark

Common questions

What is a 'pulmonary embolism'?

It's a blood clot that travels to the lungs, blocking blood flow.

What does 'intermediate-high risk' mean?

It means the clot is significant and needs careful treatment, but isn't immediately life-threatening.

What are 'blood thinners'?

Medicines like heparin or tinzaparin that stop clots from growing and help the body break them down.

What is 'embolectomy'?

A procedure to physically remove a blood clot from your body.

How long will I be followed up for?

You will be followed up for at least 3 months after your initial treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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