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
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) .
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 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. Co-enroment with Pheast has been approved. Please contact Christine Roffe or Wing To (Study manager) for details of other studies.
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No of Sites open: 15 No of patients enrolled: 109
- 001 Stoke-on-Trent 8.3.24 (Dr Phillip Ferdinand, Ass PI Dr Sumi George) 36
- 002 Bath, Royal United Hosptial (Dr Andrew Stone) 16
- 003 Whiston Hospital (Dr Sunanda Mavinamane) 8
- 004 Fairfield General Hospital (Dr Saravanan Narayanamoorthi) 8
- 005 Bury St Edmunds (Dr Abul Azim) 2
- 006 Chester 16.4.24 (Dr Kausik Chatterjee Ass PI Lucy London) 11
- 008 Bournemouth 15.4.24 (Dr Kamy Thavanesan) 11
- 010 Nottingham 12.07.2024 (Dr Ashit Shetty, Ass PI Dr Chaudhary Abdul Rehman) 1
- 011 Cambridge 2.4.24 (Dr Smriti Agarwal, Ass PI Claudia Zeicu) 13
- 012 Northwick Park 10.7.24 (Dr Aravith Sivagranarathnam) 3
- 014 Wolverhampton 26.11.24 (Dr Nasar Ahmad)
- 015 Salford 15.10.2024 (Dr Kirsty Ward, Ass PI Dr Motunrayo Wadzani )
Sites in the process of joining soon
- Stockport (Dr Georgina Randle) SIV 16 Sept close to opening
- London King’s (Dr Yee Mah) SQV done SIV done end Sept 2024 agreement still needs signing
- Wolverhampton (Dr Nasar Ahmad) SQV done SIV Jul, c&C done, need sign offs del Logs training logs
- Birmingham (Dr Mark Wilmot co-PI Dr Suraj Parikh) Mock assessments outstanding trining logs signatures
- Crewe, Leighton Hospital (Holly Maguire) Call with vascular team 18.9 agreed to 2 per month, pacs team next
- Milton Keynes (Dr Yaw Doudu) Stockport (Dr Georgina Randle) SQV done R& D review awaiting C&C
- Sheffiled (Dr AaizzaNaqvi) need confirmation of vascular support SQV 8.11.24
- Wycombe Hosptial (Dr Amulya Misra) SQV done awaiting radiographers staff changes unclear if still viable
- Ulster (Dr Mark Bowman) SQV 12 June need amendment to proceed
- Aberdeen (Dr German Guiterrez) SQV done need amendment to proceed
- Colchester (Dr Ramachandran Sivakumar) awaiting SQV no dates received capacity issues
- Yeovil (Dr Khalid Rashed) agreement signed awaiting mock ass and c&C
- Leeds (Dr Ahmad Hassan) SQV complete
- Fife (Dr Vera Cvoro) SQV to be booked need amendment to proceed, 2 repat sites.
- Royal Cornwall (Dr Katja Adie) needs confirmation from vascular team
- Coventry (Dr Uzma Khan) feasibility completed
- Watford (Dr Mohit Bandari) feasibility returned
- Bradford (Dr Numan Khan) SQV Done Sept 2024, missing vasc scientist
Declined
Royal Berkshire: No capacity May 2024
East Kent (Dr Rami Abdallah) SQV no longer have capacity
We are still looking for centres. Please contact Christine Roffe or Wing To (Study manager) if you are interested in running the study at your hosptial.
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.