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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Firstkind Ltd
- Enrollment
- 1,200
- Locations
- 18
- Primary Endpoint
- Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The trial will be single blind for the primary outcome. Devices will be taken off before participants have Doppler imaging at 7 days and 14 days. Data on VTE will be taken by a blinded researcher using information available on hospital information systems.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Single or double leg amputations
Arms & Interventions
geko™ T-3 interventional
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.
Intervention: geko™ device (Device)
Intermittent Pneumatic Compression (IPC)
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Health related quality of life using EQ-5D-5L(At 90 days after randomisation)
- Adverse Event Assessments(Up to 30 days after randomisation or discharge, whichever comes earlier)
- Device Acceptability(At 14 days after randomisation)
- Device effectiveness(At 30 days after randomisation)
- Leg pain level using a Numerical Rating Scale (NRS) score(At 90 days after randomisation)
- Disability using the modified Rankin score(At 90 days after randomisation)
- Assessment of any symptomatic or asymptomatic DVT or PE(At 90 days after randomisation)
- Patient survival(At 90 days after randomisation)
- NIH Stroke Scale/Score (NIHSS)(At 7 days (optional/if practical) and 14 days after randomisation)