GEKO Venous Thromboembolism Prevention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirstkind Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
geko™ device
DeviceNeuromuscular electrical stimulation of the peroneal nerve
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: geko™ T-3 interventionalExperimental treatment 1 intervention
Group B: Intermittent Pneumatic Compression (IPC)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.Secondary outcomes
1
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.
Time frame
At 14 days after randomisation2
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.
Time frame
At 30 days after randomisation3
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.
Time frame
At 90 days after randomisation4
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.
Time frame
At 90 days after randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Firstkind Ltd
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Keele University
Collaborator
University Hospitals of North Midlands NHS Trust
Collaborator
University of California
Collaborator
Bournemouth University
Collaborator
Source ClinicalTrials.gov