GEKO Venous Thromboembolism Prevention Study

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476913
• Other study ID #: FSK-VTE-001
• Secondary ID: ISRCTN11175235
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Firstkind Ltd
• Contact: Kieron Day, DPhil
• Phone: +44 (0) 7921 106253
• Email: Kieron.Day[@]firstkindmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Stroke
• Stroke, Acute
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Device:
• geko™ device
Neuromuscular electrical stimulation of the peroneal nerve

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital	Bath
United Kingdom	The Royal Bournemouth Hospital	Bournemouth
United Kingdom	Fairfield General Hospital	Bury
United Kingdom	West Suffolk Hospital	Bury St Edmunds	Suffolk
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Countess of Chester Hospital	Chester
United Kingdom	Whiston Hospital	Liverpool

Sponsors (6)

Lead Sponsor	Collaborator
Firstkind Ltd	Bournemouth University, Keele University, National Institute for Health Research, United Kingdom, University Hospitals of North Midlands NHS Trust, University of California

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Secondary	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 14 days after randomisation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Event Assessments	Incidence of Adverse Events in each group will be recorded.	Up to 30 days after randomisation or discharge, whichever comes earlier
Secondary	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 (optional/if practical), 14 days and 30 days after randomisation or at discharge if patient recovers earlier

External Links

•   Device official website
•   Prof Roffe, official website