Status:

RECRUITING

GEKO Venous Thromboembolism Prevention Study

Lead Sponsor:

Firstkind Ltd

Collaborating Sponsors:

National Institute for Health Research, United Kingdom

Keele University

Conditions:

Stroke, Acute

Venous Thromboembolism

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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, ...

Detailed Description

Venous thromboembolism (VTE) is a disabling and potentially fatal outcome that may be acquired after having a stroke. The standard treatment to prevent the development of VTE is to give anticoagulatio...

Eligibility Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Clinical diagnosis of acute stroke (WHO criteria)
  3. Within 36 hours of symptom onset
  4. Not able to get up from a chair/out of bed and walk to the toilet without the help of another person

Exclusion Criteria:

  1. Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee

  2. Unwitnessed onset with a long lie on the floor before admission

  3. Clinically apparent deep vein thrombosis at screening

  4. Patient is expected to require palliative care within 14 days

  5. Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.

  6. Patient has recently been involved in or is currently involved in a clinical trial for either a medical device or medicinal product, within the past 3 months, with the exception: if co-enrolment is not considered to impact adverse events or outcomes in the opinion of the Chief Investigator. (A live document containing a list of approved studies will be included in a reference document made available to all study sites and available upon request)

  7. Contraindications for the use of the geko™ device:

    • Allergy to hydrogel constituents
  8. Contraindications to IPC:

    • Severe peripheral vascular disease
    • Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
    • Severe oedema
    • Leg deformities making appropriate fitting impossible
  9. Uncontrolled congestive cardiac failure

  10. Pregnancy

  11. Single or double leg amputations

Key Trial Info

Start Date :

July 6 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2025

Estimated Enrollment :

1200 Patients enrolled

Trial Details

Trial ID

NCT05476913

Start Date

July 6 2023

End Date

June 30 2025

Last Update

March 4 2025

Active Locations (18)

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Page 1 of 5 (18 locations)

1

West Suffolk Hospital

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

2

Royal United Hospital

Bath, United Kingdom, BA1 3NG

3

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2GW

4

The Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW