GEKO Venous Thromboembolism Prevention Study
Research type
Research Study
Full 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
IRAS ID
315387
Contact name
Christine Roffe
Contact email
Sponsor organisation
Firstkind Ltd
ISRCTN Number
ISRCTN11175235
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Formation of a blood clot in the vein is called venous thromboembolism (VTE). This includes conditions such as deep vein thrombosis (DVT), where a clot forms in a deep vein usually in the lower leg. If the blood clot travels to the lung, this is called a pulmonary embolism (PE) and can be fatal. The risk of developing a VTE is increased after having a stroke due to lack of movement, which slows blood flow and can increase the chance of the blood clotting. Although there is medication available to help prevent the development of blood clots, these are not considered suitable for stroke patients. Current recommended preventative treatment is the use of Intermittent Pneumatic Compression (IPC), where cuffs are placed around the lower legs and filled with air to help squeeze the legs and induce blood flow. However, this is not suitable for all patients. Another treatment which has shown promising results to prevent VTE, is with a medical device called the geko™ device, which stimulates a nerve in the leg causing the muscles to contract and increases blood circulation. 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 and are discharged, or for a maximum of 30 days. A Doppler exam (special type of ultrasound), will be conducted at 7 days and 14 days after randomisation, or at discharge if the patient recovers earlier within a 3 day window. A follow-up after 30 days or at patient discharge if earlier, will collect relevant health related information (e.g. VTE status and stroke recurrence) and includes a patient questionnaire about the comfort of the applied devices. A final follow-up will then be conducted over the phone after 90 days to follow-up on the patient's vital status, any VTE diagnoses and other outcomes.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0001
Date of REC Opinion
21 Feb 2023
REC opinion
Further Information Favourable Opinion