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 ISRCTN11175235
Chief Investigator: Professor Christine Roffe, Keele University
Venous thromboembolism (VTE) is a major cause of preventable death and long-term disability after stroke. Current recommended preventative treatment is the use of Intermittent Pneumatic Compression (IPC). However, about 30% of patietns have contraindications to or do not tolerate IPC. An alternative form of mechanical thromboprophylaxia is electrical stimulation of the peroneal nerve, which improves venous flow in the leg by muscle contraction. The aim of this study is to determine if stimulation of leg muscle contraction using the geko™ device is more effective at preventing VTE in immobile acute stroke patients than the current IPC standard of care treatment.
We will enrol 1200 patietns will from >20 acute stroke units in the UK into a randomized controlled trial comparing the geko™ device intermittent pneumatic compression (study summary) .
We can co-enrol with observational studies studies on agreement of both CIs and the Sponsors. for intnervetional studies (drug or device) agreement of both CIs and both Sponsors is needed. Please contact Christine Roffe or Wing To (Study manager) for details.
No of Sites open: 3 No of patients randomized: 7
Bath, Royal United Hosptial (Dr Andrew Stone) 5
Farifield General Hospital (Dr Saravanan Narayanamoorthi) 2
This study is funded by the NIHR i4i Challenge (NIHR203425). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.