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:
- Age 18 years or older
- Clinical diagnosis of acute stroke (WHO criteria)
- Within 36 hours of symptom onset
- Not able to get up from a chair/out of bed and walk to the toilet without the help of another person
Exclusion Criteria:
-
Inability to gain consent from the patient, or a declaration from a Personal Consultee or Nominated Consultee
-
Unwitnessed onset with a long lie on the floor before admission
-
Clinically apparent deep vein thrombosis at screening
-
Patient is expected to require palliative care within 14 days
-
Patient does not live in the local catchment area and is expected to be transferred to their local hospital for on-going care.
-
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)
-
Contraindications for the use of the geko™ device:
- Allergy to hydrogel constituents
-
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
-
Uncontrolled congestive cardiac failure
-
Pregnancy
-
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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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