GEKO Venous Thromboembolism Prevention Study

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 Doppler exam of the legs will be conducted after 7 days and after 14 days, or at discharge if the patient recovers earlier. A follow-up including a patient questionnaire about the comfort of the device, as well as additional health information will be collected after 30 days, or at discharge if earlier. 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.

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

Conditions
-----------------
Stroke, Acute, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

Intervention / Treatment
-----------------
* Device: geko™ device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standard block randomisation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: geko™ T-3 interventional<br>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 and is discharged, whichever comes earlier. | Device: geko™ device<br>* Neuromuscular electrical stimulation of the peroneal nerve<br>* Other names: NMES;|
| No Intervention: Intermittent Pneumatic Compression (IPC)<br>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 and is discharged, whichever comes earlier. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From randomisation to 30 days. Dopplers at 7 d and 14 d after randomisation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 30 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. | 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. | 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. | 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. | 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. | 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. | At 90 days after randomisation | 
| Adverse Event Assessments | Incidence of Adverse Events in each group will be recorded. | 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. | At 7 days, 14 days and 30 days after randomisation or at discharge if patient recovers earlier | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geko, intermittent pneumatic compression, Stroke, Acute, Venous Thromboembolism, Pulmonary Embolism, DVT prophylaxis