Clinical trial of electrical stimulation of leg muscles as a new way to prevent deep vein thrombosis and pulmonary embolism after stroke

Not Applicable

• Conditions: Prevention of venous thromboembolism in acute stroke patients; Circulatory System; Venous thromboembolism

• Registration Number: ISRCTN11175235
• Lead Sponsor: Firstkind Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Last Update Posted: 27 May 2024
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Aged 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 ongoing 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
7. Contraindications for the use of the geko™ device:
7.1. Allergy to hydrogel constituents
8. Contraindications to IPC:
8.1. Severe peripheral vascular disease
8.2. Large leg ulcers requiring extensive bandaging (small ulcers or skin breaks with flat coverings are not an exclusion)
8.3. Severe oedema
8.4. Leg deformities making appropriate fitting impossible
8.5. Uncontrolled congestive cardiac failure
9. Pregnancy or breastfeeding
10. Single or double leg amputations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 17/05/2024:<br>Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE) within 30 days of randomisation. DVT will be diagnosed using whole leg compression Doppler imaging, conducted any time there is a clinical suspicion of DVT and at 7 days (optional) and 14 days (mandatory) after randomisation.<br><br><br><br><br>Previous primary outcome measure:<br>Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE) within 30 days of randomisation. DVT will be diagnosed using whole leg compression Doppler imaging, conducted any time there is a clinical suspicion of DVT and at 7 days and 14 days after randomisation, or at patient discharge if the patient recovers within a 3-day window of these follow-up timepoints.