Clinical trial NCT05476913: GEKO Venous Thromboembolism Prevention 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Keywords: geko
intermittent pneumatic compression
Stroke, Acute
Venous Thromboembolism
Pulmonary Embolism
DVT prophylaxis
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
Collaborators: name: National Institute for Health Research, United Kingdom
name: Keele University
name: University Hospitals of North Midlands NHS Trust
name: University of California
name: Bournemouth University
First posted: 2022-07-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard block randomisation
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Clinical diagnosis of acute stroke (WHO criteria)
3. Within 36 hours of symptom onset
4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person

Exclusion Criteria:

1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
2. Unwitnessed onset with a long lie on the floor before admission
3. Clinically apparent deep vein thrombosis at screening
4. Patient is expected to require palliative care within 14 days
5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
6. 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)
7. Contraindications for the use of the geko™ device:

   * Allergy to hydrogel constituents
8. 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
9. Uncontrolled congestive cardiac failure
10. Pregnancy
11. Single or double leg amputations

Primary outcomes:
measure: Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
timeFrame: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Secondary outcomes:
measure: Device Acceptability
timeFrame: At 14 days after randomisation
measure: Device effectiveness
timeFrame: At 30 days after randomisation
measure: Leg pain level using a Numerical Rating Scale (NRS) score
timeFrame: At 90 days after randomisation
measure: Disability using the modified Rankin score
timeFrame: At 90 days after randomisation
measure: Health related quality of life using EQ-5D-5L
timeFrame: At 90 days after randomisation
measure: Patient survival
timeFrame: At 90 days after randomisation
measure: Assessment of any symptomatic or asymptomatic DVT or PE
timeFrame: At 90 days after randomisation
measure: Adverse Event Assessments
timeFrame: Up to 30 days after randomisation or discharge, whichever comes earlier
measure: NIH Stroke Scale/Score (NIHSS)
timeFrame: At 7 days (optional/if practical) and 14 days after randomisation
Other outcomes:
Locations:
city: Bury St Edmunds
country: United Kingdom
facility: West Suffolk Hospital
state: Suffolk
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
city: Liverpool
country: United Kingdom
facility: Whiston Hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Yeovil
country: United Kingdom
facility: Yeovil Hospital
Study officials:
affiliation: Keele University, University Hospitals of North Midlands NHS Trust
name: Christine Roffe, MD FRCP FESO
role: PRINCIPAL_INVESTIGATOR
References: