VENOUS THROMBOEMBOLI SM
are contraindicated for IPC, drugs are not recommended by NICE in the first instance due to the possibility of haemorrhagic transformation. Furthermore, hyperacute stroke patients are unable to receive drugs at all, so if they also cannot tolerate IPC, a gap in care begins to emerge. This gap represented an urgent area of unmet clinical need, brought about by the restrictions of only having one non-pharmacological intervention – which limited us to prevent VTE in every at-risk patient.
The baseline VTE incidence risk of this unmet need in acute stroke patients, reported in the CLOTS3 study, is 8.7% (no IPC, plus standard measures). The CLOTS3 study also reports that >30% of acute stroke patients can be contraindicated or not tolerate IPC.2
Addressing the need
As a unit, we firmly believe that we must make every effort to provide a standard of care that encompasses the entire patient population. This significant unmet need gave us the opportunity to think outside of the box, and explore new ways to address VTE prevention. Sky Medical Technology, a developer of a neuromuscular electrostimulation (NMES) technology, were interested in exploring its effectiveness in VTE prevention, and reached out to our unit to discuss collaborative research. The technology, embedded in a small, wristwatch-style device called the Geko, sends painless, regular electrical pulses down a patient’s lower limb, stimulating the common peroneal nerve in the lower leg and activating calf and muscle pumps. The mechanism of action increases blood flow in the deep veins of the calf – equal to 60% of the blood flow rate of walking, without the patient moving – thereby preventing vascular complications associated with restricted mobility, a common risk for bed-bound stroke patients. It had clear potential as a non-invasive, non-
pharmacological intervention to prevent VTE in a patient group contraindicated or unable to tolerate IPC.
Of course, all treatment must be evidence based. As a unit, we recognised the need to generate data to determine the Geko device’s efficacy and to remain aligned to our priority of patient safety. We agreed to qualify, through an observational pilot study, patient contraindication and intolerance to IPC, to measure Geko compliance compared to IPC, and to measure VTE events at 90 days post-stroke.
Changing clinical practice Any pilot study involving patients involves a huge amount of staff effort, time and investment, not least of all for the initial stages of securing buy-in from the Trust. Rigorous processes of governance are required pre- study, and we first contacted the Directorate Governance for neurosciences to inform them of our wish to commence a pilot observational study and make a solid case for pursuing it. The study also sought permission from Divisional Governance and Trust Governance; these groups were on hand to approve each stage of the study, including the proposed inclusion / exclusion criteria and the process of patient recruitment, monitoring and follow up. It was thanks to the collective effort of the stroke unit team, who ensured the study proposal was properly devised, that Governance agreed permission and support for the pilot.
Given that we were exploring the use of the Geko as a prescribed device, we also informed the Royal Stoke University Hospital pharmacy in order to add the Geko to a drug chart alongside other standards of care for VTE; this was an important step, which allowed us to implement use of the device in the study. It was also vital to have a database in place to enable the team to track and carefully monitor patients selected to participate. With an initial patient goal of 1,000, it took roughly around one year to collect data from each patient. A study of this scale meant
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