A randomised controlled trial of the effectiveness of intermittent surface neuromuscular stimulation using the geko™ device compared with intermittent pneumatic compression to prevent venous thromboembolism in immobile acute stroke patients

Firstkind Limited0 个研究点目标入组 1,200 人开始时间: 2022年9月23日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•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

•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

发起方

Firstkind Limited