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RecruitingNAINTERVENTIONAL

GEKO Venous Thromboembolism Prevention Study

This study, called the GEKO Venous Thromboembolism Prevention Study, aims to find out the best way to prevent dangerous blood clots (called Deep Vein Thrombosis or Pulmonary Embolism, which together are known as VTE) in people who have recently had a stroke and can't move around much. After a stroke, people are at higher risk of these clots. Currently, the common treatment in the UK for this is Intermittent Pneumatic Compression (IPC), which uses air-filled cuffs to help blood flow in the legs. This study will compare IPC with a new medical device called geko™, which uses gentle electrical pulses to increase blood circulation. Patients will be randomly assigned to receive one of these treatments, and researchers will follow their progress for 90 days to see how well each method prevents VTE.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Firstkind Ltd
Enrolment target
1,200
Start
06 Jul 2023
Estimated completion
30 Jun 2025

What is this study about?

After a stroke, it can be hard to move around, and this can increase the risk of developing blood clots in the legs (Deep Vein Thrombosis, or DVT) or lungs (Pulmonary Embolism, or PE). Together, these are known as Venous Thromboembolism, or VTE. These clots can be very serious. While medication can prevent clots, it's generally not recommended soon after a stroke in the UK. Instead, hospitals often use a method called Intermittent Pneumatic Compression (IPC).

IPC involves wearing special cuffs on your lower legs that gently inflate and deflate with air. This squeezing action helps to keep your blood flowing, reducing the chance of clots. However, not everyone can use IPC, or some may find it uncomfortable. This study is looking at another promising device called the geko™ device. This device is worn on the leg and uses mild electrical stimulation to promote blood flow. It has a special approval (CE mark) meaning it meets safety and performance standards for increasing circulation.

The main goal of this study is to see if the geko™ device is better than the current IPC treatment at preventing these blood clots in stroke patients who are unable to move much. Participants in the study will be randomly chosen to receive either the IPC treatment or the geko™ device. Both treatments will be used until the person can walk on their own again, or for a maximum of 30 days. Researchers will then check for any blood clots and collect information on how well participants recover over a 90-day period.

Key takeaways

  • Aims to prevent blood clots in stroke patients.
  • Compares standard treatment (IPC) with a new device (geko™).
  • Participation involves using a device for up to 30 days.
  • Researchers will follow your health for 90 days.
  • Helps understand the best ways to care for stroke patients.
  • Your involvement is voluntary and you can stop anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with a stroke within the last 36 hours. You also need to be unable to walk to the toilet without help.

There are several reasons why you might not be able to join. For example, if you already have a diagnosed blood clot, or if you're expected to need end-of-life care in the next couple of weeks. You also can't take part if you've recently been in another clinical trial in the last three months, unless the study team agrees it won't affect the results.

Certain health conditions or allergies might also mean you can't join, particularly if they prevent you from safely using the geko™ device or the IPC cuffs. These include serious leg ulcers, severe swelling in your legs, or if you are pregnant, have uncontrolled heart failure, or have had leg amputations.

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 had a stroke within the last 36 hours?
  3. Are you currently unable to walk without help?
  4. Do you have any serious leg ulcers or severe leg swelling?
  5. Are you pregnant or do you have uncontrolled heart problems?
  6. Have you recently been in another medical trial (in the last 3 months)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a consent process to make sure you understand everything. You'll then be randomly assigned to receive either the standard IPC treatment or the geko™ device. Both treatments will be applied to your legs and kept on until you can walk without help, or for up to 30 days, whichever comes first.

Throughout the study, nurses or doctors will perform checks. Around 7 days or when you leave the hospital, they might do an optional scan of your legs to check for clots. A mandatory scan will be done after 14 days. At this 14-day mark, you'll also be asked to complete a questionnaire about how comfortable you found your device and to provide some general health information.

After 30 days, hospital staff will collect an update on your health from your medical records, looking for any signs of deep vein clots or lung clots. The final check will be a phone call 90 days after you started the study, where the team will ask about your overall recovery, health, how well you can move, and your quality of life.

Potential risks and benefits

By taking part in this study, you might benefit from receiving either the standard treatment or a new device that could potentially be more effective at preventing dangerous blood clots after a stroke. The study helps researchers understand the best ways to care for stroke patients, which benefits future patients. As with any medical treatment, there's always a small chance of side effects or discomfort from either the IPC device or the geko™ device. The study is designed with your safety in mind. Importantly, your decision to take part is completely voluntary, and you are free to withdraw from the study at any time without it affecting your ongoing medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • West Suffolk Hospital
    Verified postcode
    Bury St Edmunds, United Kingdom· Recruiting
  • Royal United Hospital
    Verified postcode
    Bath, United Kingdom· Recruiting
  • Queen Elizabeth Hospital Birmingham
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • The Royal Bournemouth Hospital
    Verified postcode
    Bournemouth, United Kingdom· Recruiting
  • Fairfield General Hospital
    Verified postcode
    Bury, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Kent and Canterbury Hospital
    Verified postcode
    Canterbury, United Kingdom· Not yet recruiting
  • Countess of Chester Hospital
    Verified postcode
    Chester, United Kingdom· Recruiting
  • Whiston Hospital
    Verified postcode
    Liverpool, United Kingdom· Recruiting
  • Northwick Park Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • King's College Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Milton Keynes University Hospital
    Verified postcode
    Milton Keynes, United Kingdom· Recruiting

Common questions

What is a 'blood clot' in this study?

In this study, a blood clot refers to a deep vein thrombosis (DVT) in your leg or a pulmonary embolism (PE) in your lung, which can be serious after a stroke.

What is the geko™ device?

The geko™ device is a small medical device that gently stimulates your leg muscles with electricity to help improve blood flow and prevent clots.

How long will I be in the study?

You'll use the assigned device for up to 30 days or until you can walk again. Researchers will then follow up on your health for a total of 90 days.

Will I know which treatment I'm getting?

Yes, you will know if you are receiving the IPC cuffs or the geko™ device.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your medical care.

How to find out more

Kieron Day, DPhil

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

Interested in taking part?

Register your interest

Share your details and the research team for "GEKO Venous Thromboembolism Prevention Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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