GEKO Venous Thromboembolism Prevention Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: geko™ device.
- Who it may be relevant to
- Registry conditions: Stroke, Acute, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device geko™ device
Neuromuscular electrical stimulation of the peroneal nerve
Primary outcome measures
- 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.]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United Kingdom · 18 centers
- West Suffolk Hospital — Bury St Edmunds
- Royal United Hospital — Bath
- Queen Elizabeth Hospital Birmingham — Birmingham
- The Royal Bournemouth Hospital — Bournemouth
- Fairfield General Hospital — Bury
- Addenbrooke's Hospital — Cambridge
- Kent and Canterbury Hospital — Canterbury
- Countess of Chester Hospital — Chester
- … and 10 more centers
Identifiers
NCT: NCT05476913 · FSK-VTE-001 · ISRCTN11175235