Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05476913

GEKO Venous Thromboembolism Prevention Study

Led by Firstkind Ltd · Updated on 2025-03-04

1200

Participants Needed

18

Research Sites

103 weeks

Total Duration

On this page

Sponsors

F

Firstkind Ltd

Lead Sponsor

N

National Institute for Health Research, United Kingdom

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

GEKO Venous Thromboembolism Prevention Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Clinical diagnosis of acute stroke (WHO criteria)
  • Within 36 hours of symptom onset
  • Unable to get up from a chair or out of bed and walk to the toilet without help from another person
Not Eligible

You will not qualify if you...

  • Unable to give consent or no suitable consultee available
  • Unwitnessed stroke onset with a long time lying on the floor before admission
  • Visible deep vein thrombosis at screening
  • Expected to need palliative care within 14 days
  • Lives outside the local hospital area and likely to be transferred elsewhere
  • Participation in another clinical trial within the past 3 months (unless approved by Chief Investigator)
  • Allergy to hydrogel in the geko17; device
  • Severe peripheral vascular disease
  • Large leg ulcers requiring extensive bandaging
  • Severe swelling (oedema)
  • Leg deformities preventing proper device fitting
  • Uncontrolled congestive heart failure
  • Pregnancy
  • Single or double leg amputations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

West Suffolk Hospital

Bury St Edmunds, Suffolk, United Kingdom, IP29 5DN

Actively Recruiting

2

Royal United Hospital

Bath, United Kingdom, BA1 3NG

Actively Recruiting

3

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2GW

Actively Recruiting

4

The Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Actively Recruiting

5

Fairfield General Hospital

Bury, United Kingdom, BL9 7TD

Actively Recruiting

6

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

7

Kent and Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

Not Yet Recruiting

8

Countess of Chester Hospital

Chester, United Kingdom, CH2 1UL

Actively Recruiting

9

Whiston Hospital

Liverpool, United Kingdom, L35 5DR

Actively Recruiting

10

Northwick Park Hospital

London, United Kingdom, HA1 3UJ

Actively Recruiting

11

King's College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

12

Milton Keynes University Hospital

Milton Keynes, United Kingdom, MK6 5LD

Actively Recruiting

13

Queen's Medical Centre

Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

14

Salford Royal Hospital

Salford, United Kingdom, M6 8HD

Actively Recruiting

15

Stepping Hill Hospital

Stockport, United Kingdom, SK2 7JE

Actively Recruiting

16

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom, ST4 6QG

Actively Recruiting

17

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Actively Recruiting

18

Yeovil Hospital

Yeovil, United Kingdom, BA21 4AT

Actively Recruiting

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Research Team

K

Kieron Day, DPhil

CONTACT

W

Wing To, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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