Stroke, AcuteNCT05476913
GEKO Venous Thromboembolism Prevention Study
A study testing geko™ device in people with Stroke, Acute and Venous Thromboembolism, run by Firstkind Ltd at 18 sites in United Kingdom.
Trial summary
This multicentre, randomised geko™ venous thromboembolism (VTE) prevention study will prospectively collect clinical data on VTE occurrences in immobile patients after stroke, who will be randomised, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Venous Thromboembolism, Deep Vein Thrombosis
- What is being tested?
- geko™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 6 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of acute stroke (WHO criteria)
- Within 36 hours of symptom onset
- Not able to get up from a chair/out of bed and walk to the toilet without the help of another person
Who cannot join
- Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
- Unwitnessed onset with a long lie on the floor before admission
- Clinically apparent deep vein thrombosis at screening
- Patient is expected to require palliative care within 14 days
- Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
- Patient has recently been involved in or is currently involved in a clinical trial for either a medical device or medicinal product, within the past 3 months, with the exception: if co-enrolment is not considered to impact adverse events or outcomes in the opinion of the Chief Investigator. (A live document containing a list of approved studies will be included in a reference document made available to all study sites and available upon request)
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- Contraindications for the use of the geko™ device:
- Allergy to hydrogel constituents
- Contraindications to IPC:
- Severe peripheral vascular disease
- Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
- Severe oedema
- Leg deformities making appropriate fitting impossible
- Uncontrolled congestive cardiac failure
- Pregnancy
- Single or double leg amputations
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United Kingdom18 sites, 18 recruiting
- Recruiting
Royal United Hospital
Bath, BA1 3NG
Hayley Stoney, ruh-tr.StrokeResearch@nhs.net
Telma Costa
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Scott Luxmore-Brown
Mark Willmot, Dr
- Recruiting
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Dhanya Babu, +44(0)300 019 5073
Kamy Thavanesan, Dr
- Recruiting
Fairfield General Hospital
Bury, BL9 7TD
Pamela Bradley
Narayanamoorthi Saravanan, Dr
- Recruiting
West Suffolk Hospital
Bury St Edmunds, Suffolk, IP29 5DN
Lisa Wood
Catherine Durrant
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Alex McGovern
Smriti Agarwal, Dr
- Not yet recruiting
Kent and Canterbury Hospital
Canterbury, CT1 3NG
Gemma Hector
Rami Abdallah, Dr
- Recruiting
Countess of Chester Hospital
Chester, CH2 1UL
Sherin Sabu
Kausik Chatterjee, Dr
- Recruiting
Whiston Hospital
Liverpool, L35 5DR
Coleen Ditchfield
Sunanda Mavinamane, Dr
- Recruiting
Northwick Park Hospital
London, HA1 3UJ
Parvathy Gopi, +44(0)2088695550
Aravinth Sivagnanaratnam, Dr
- Recruiting
King's College Hospital
London, SE5 9RS
Con Tibajia, +44(0)2032997506 ext. 37506
Yee-Haur Mah, Dr
- Recruiting
Milton Keynes University Hospital
Milton Keynes, MK6 5LD
Cheryl Padilla-Harris
Yaw Duodu, Dr
- Recruiting
Queen's Medical Centre
Nottingham, NG7 2UH
Amanda Hedstrom, +44(0)1158231807
Ashit Shetty, Dr
- Recruiting
Salford Royal Hospital
Salford, M6 8HD
Reece Doonan, +44(0)161 206 2188
Kirsty Ward, Dr
- Recruiting
Stepping Hill Hospital
Stockport, SK2 7JE
Seethalekshmi Vikramadhithyan, +44(0)161 419 5893 ext. 115786
Clare Tibke
- Recruiting
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Surabhi Saxena, +44(0)1782671988
Phillip Ferdinand, Dr
- Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
Tegan Taylor, +44(0)1902307999 ext. 86849
Nasar Ahmad, Dr
- Recruiting
Yeovil Hospital
Yeovil, BA21 4AT
Alfonso Tanate, +44(0)193538 4297
Khalid Rashed, Dr
About this study
Official title: A Randomised Controlled Trial of the Effectiveness of Intermittent Surface Neuromuscular Stimulation Using the Geko™ Device Compared With Intermittent Pneumatic Compression to Prevent Venous Thromboembolism in Immobile Acute Stroke Patients
This multicentre, randomised geko™ venous thromboembolism (VTE) prevention study will prospectively collect clinical data on VTE occurrences in immobile patients after stroke, who will be randomised, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.
Read the detailed description
Venous thromboembolism (VTE) is a disabling and potentially fatal outcome that may be acquired after having a stroke. The standard treatment to prevent the development of VTE is to give anticoagulation medication. However, this is not recommended in the UK after stroke. Instead the recommended treatment is Intermittent Pneumatic Compression (IPC), where cuffs placed around the lower legs are filled with air to help squeeze the legs and induce blood flow. However, not all patients are able to receive or tolerate IPC treatment. Another treatment which has shown promising results to prevent VTE in immobile patients after stroke, is with a medical device called the geko™ device. The geko™ device is a CE marked medical device which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its' intended use which is to increase blood circulation to help prevent VTE. The aim of this study is to determine if the geko™ device is more effective at preventing VTE in immobile acute stroke patients, than the current IPC standard of care treatment. Following the consent process, stroke patients will be randomised to receive either IPC or geko device. Both devices will be applied until the patient can walk again without help, or for a maximum of 30 days. A compression Doppler exam of the legs will be conducted after 7 days or at discharge if the patient recovers earlier (optional) and after 14 days (mandatory). At 14 days post-randomisation, a patient questionnaire about the comfort of the device, as well as additional health information will be collected. At 30 days after randomisation, additional information about symptomatic DVTs or PEs etc., will be collected from the participant's medical notes. A final follow-up will then be conducted over the phone after 90 days to find out about the patient's recovery, health, mobility and quality of life.
- Being tested
- geko™ device
- Keywords
- geko, intermittent pneumatic compression, Stroke, Acute, Venous Thromboembolism, Pulmonary Embolism, DVT prophylaxis
- Medical subject headings
- Stroke, Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko™ deviceDevice
Also called geko, NMES
Neuromuscular electrical stimulation of the peroneal nerve
| Study group | Role | What they receive |
|---|---|---|
| geko™ T-3 interventional | Experimental | The geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier. Receives: Device: geko™ device |
| Intermittent Pneumatic Compression (IPC) | No intervention | Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
Determine the number of patients diagnosed to have a VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care. Asymptomatic DVT will be diagnosed using above knee compression Doppler (Compression Duplex Ultrasound) and PE will be diagnosed using ventilation perfusion scan or by computer tomography pulmonary angiogram (CTPA). Compression Dopplers will be conducted any time there is a clinical suspicion of DVT. Above knee compression Dopplers will be conducted at 7 days and 14 days after randomisation, or at patient discharge if patient recovers earlier than 7 d and 14 days post-randomisation.
Measured: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Secondary outcomes (9)
Device Acceptability
To assess patient tolerability of the geko™ device compared to IPC standard of care, a device acceptability questionnaire will be utilised, which includes questions on discomfort, sleep quality, number of times the device is checked and not in place/not working effectively and number of days the device was worn. Answers to each question will be summarised.
Measured: At 14 days after randomisation
Device effectiveness
Determine frequency of patient death for any cause, confirmed fatal or non-fatal PE, any (symptomatic or asymptomatic) above knee DVT, any (symptomatic or asymptomatic) popliteal or femoral vein DVT or symptomatic calf vein DVT, and combination of these outcomes. The frequency will be compared between the two groups: geko™ device compared to IPC standard of care.
Measured: At 30 days after randomisation
Leg pain level using a Numerical Rating Scale (NRS) score
Assessing pain levels using a Numerical Rating Scale (NRS) score: a line from 0 - 10, where 0 means no pain and 10 is the worst possible pain.
Measured: At 90 days after randomisation
Disability using the modified Rankin score
The modified Rankin score will be used to measure Neurologic Disability. This is a 7-level, clinician reported measure of global disability with possible scores ranging from 0 to 6, where 0 represents "no symptoms at all", 5 represents "severe disability; bedridden, incontinent and requiring constant nursing care and attention" and 6 indicates patient death.
Measured: At 90 days after randomisation
Health related quality of life using EQ-5D-5L
A validated patient reported outcome measure, the first part of the EQ-5D-5L score is a simple 5-level questionnaire: patient mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each question has five response levels from no problems (Level 1) to extreme problems (Level 5). The second part of the EQ-5D is an EQ VAS to record the patient's self-rated health scored on a 0 - 100 scale representing "the worst…" and "the best health you can imagine", respectively.
Measured: At 90 days after randomisation
Patient survival
Death from any cause will be recorded, comparing the two groups: geko™ device compared to IPC standard of care.
Measured: At 90 days after randomisation
Assessment of any symptomatic or asymptomatic DVT or PE
Determine the frequency of VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care.
Measured: At 90 days after randomisation
Adverse Event Assessments
Incidence of Adverse Events in each group will be recorded.
Measured: Up to 30 days after randomisation or discharge, whichever comes earlier
NIH Stroke Scale/Score (NIHSS)
The NIHSS scores areas such as level of consciousness, vision, sensation, movement, speech and language with a minimum score of 0 representing no stroke, and 21-42 points representing severe stroke. NIHSS will be compared between the two groups: geko™ device compared to IPC standard of care.
Measured: At 7 days (optional/if practical) and 14 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start6 Jul 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Standard block randomisation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom, Keele University, University Hospitals of North Midlands NHS Trust, University of California, Bournemouth University
- Responsible party
- Sponsor
- Investigators
- Christine Roffe, MD FRCP FESO, Principal investigator, Keele University, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476913
- Sponsor's protocol ID
- FSK-VTE-001
- Other IDs
- ISRCTN11175235
- Status last verified
- Feb 2025
- First submitted
- 21 Jul 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Effectiveness of Intermittent Surface Neuromuscular Stimulation Using the Geko™ Device Compared With Intermittent Pneumatic Compression to Prevent Venous Thromboembolism in Immobile Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT05476913
- Acronym / sponsor ID
- FSK-VTE-001
- Keywords
- geko, intermittent pneumatic compression, Stroke, Acute, Venous Thromboembolism, Pulmonary Embolism, DVT prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom, Keele University, University Hospitals of North Midlands NHS Trust, University of California, Bournemouth University
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre, randomised geko™ venous thromboembolism (VTE) prevention study will prospectively collect clinical data on VTE occurrences in immobile patients after stroke, who will be randomised, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.
Detailed description
Venous thromboembolism (VTE) is a disabling and potentially fatal outcome that may be acquired after having a stroke. The standard treatment to prevent the development of VTE is to give anticoagulation medication. However, this is not recommended in the UK after stroke. Instead the recommended treatment is Intermittent Pneumatic Compression (IPC), where cuffs placed around the lower legs are filled with air to help squeeze the legs and induce blood flow. However, not all patients are able to receive or tolerate IPC treatment. Another treatment which has shown promising results to prevent VTE in immobile patients after stroke, is with a medical device called the geko™ device. The geko™ device is a CE marked medical device which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its' intended use which is to increase blood circulation to help prevent VTE. The aim of this study is to determine if the geko™ device is more effective at preventing VTE in immobile acute stroke patients, than the current IPC standard of care treatment. Following the consent process, stroke patients will be randomised to receive either IPC or geko device. Both devices will be applied until the patient can walk again without help, or for a maximum of 30 days. A compression Doppler exam of the legs will be conducted after 7 days or at discharge if the patient recovers earlier (optional) and after 14 days (mandatory). At 14 days post-randomisation, a patient questionnaire about the comfort of the device, as well as additional health information will be collected. At 30 days after randomisation, additional information about symptomatic DVTs or PEs etc., will be collected from the participant's medical notes. A final follow-up will then be conducted over the phone after 90 days to find out about the patient's recovery, health, mobility and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Standard block randomisation
| Arm | Type | Receives |
|---|---|---|
| geko™ T-3 interventional | Experimental | Device: geko™ deviceThe geko™ device will be applied bilaterally as soon as possible after randomisation and each geko™ device will be used to deliver one 24-hour dose. Devices will be worn continuously and changed every 24 hours. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier. |
| Intermittent Pneumatic Compression (IPC) | No intervention | –Control treatment will be IPC using NHS approved devices as used for standard clinical care. They will be applied to both legs as soon as possible after randomisation. They will not be changed unless damaged or soiled. Treatment will be continued for a maximum of 30 days or until patient recovers mobility, or is discharged into the community, or meet other defined criteria, whichever comes earlier. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Clinical diagnosis of acute stroke (WHO criteria)
- Within 36 hours of symptom onset
- Not able to get up from a chair/out of bed and walk to the toilet without the help of another person
Key exclusion criteria (16 listed)
- Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
- Unwitnessed onset with a long lie on the floor before admission
- Clinically apparent deep vein thrombosis at screening
- Patient is expected to require palliative care within 14 days
- Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geko™ deviceAlso: geko, NMESNeuromuscular electrical stimulation of the peroneal nerve | Device | geko™ T-3 interventional |
Primary outcome
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
Time frame: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Determine the number of patients diagnosed to have a VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care. Asymptomatic DVT will be diagnosed using above knee compression Doppler (Compression Duplex Ultrasound) and PE will be diagnosed using ventilation perfusion scan or by computer tomography pulmonary angiogram (CTPA). Compression Dopplers will be conducted any time there is a clinical suspicion of DVT. Above knee compression Dopplers will be conducted at 7 days and 14 days after randomisation, or at patient discharge if patient recovers earlier than 7 d and 14 days post-randomisation.
9 secondary outcomes
Device Acceptability
Time frame: At 14 days after randomisation
Device effectiveness
Time frame: At 30 days after randomisation
Leg pain level using a Numerical Rating Scale (NRS) score
Time frame: At 90 days after randomisation
Disability using the modified Rankin score
Time frame: At 90 days after randomisation
Health related quality of life using EQ-5D-5L
Time frame: At 90 days after randomisation
Patient survival
Time frame: At 90 days after randomisation
Assessment of any symptomatic or asymptomatic DVT or PE
Time frame: At 90 days after randomisation
Adverse Event Assessments
Time frame: Up to 30 days after randomisation or discharge, whichever comes earlier
NIH Stroke Scale/Score (NIHSS)
Time frame: At 7 days (optional/if practical) and 14 days after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Device official websiteLink provided by the sponsor.
- Prof Roffe, official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Roffe, MD FRCP FESO principal investigator
Keele University, University Hospitals of North Midlands NHS Trust
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko™ device in people with Stroke, Acute and Venous Thromboembolism, run by Firstkind Ltd at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kieron Day, DPhil (+44 (0) 7921 106253, Kieron.Day@firstkindmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE). (time frame: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.