GEKO Venous Thromboembolism Prevention Study

Launched by FIRSTKIND LTD · Jul 25, 2022

Keywords

ClinConnect Summary

The GEKO Venous Thromboembolism Prevention Study is looking at ways to prevent blood clots in patients who have had a stroke and are unable to move around much. In this study, participants will be randomly assigned to receive either standard care, which involves using a machine that gently squeezes the legs to promote blood flow, or a new device called the geko™, which uses gentle electrical stimulation to help prevent blood clots. Researchers will follow the participants for three months to see how effective these two methods are in preventing complications like deep vein thrombosis or pulmonary embolism.

To be eligible for this trial, participants must be at least 18 years old and have recently experienced an acute stroke, meaning they have had symptoms for less than 36 hours. They should also need assistance to move around, indicating they are immobile. Participants will be monitored throughout the study, and it’s important to note that those with certain medical conditions or who are currently involved in other clinical trials may not be able to participate. This study aims to provide valuable information that could improve care for stroke patients and reduce the risk of serious complications.

Gender

ALL

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