GEKO Venous Thromboembolism Prevention Study

Официальное название

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

Обзор

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, on a 1:1 allocation, to receive either standard of care (Intermittent Pneumatic Compression) or geko™ neuromuscular electrostimulation device. The aim is to assess the prevention of VTE during a follow-up period of 90 days (three months) post-randomisation.

Подробное описание

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 anticoagulation medication. However, this is not recommended in the UK after stroke. Instead the recommended treatment is Intermittent Pneumatic Compression (IPC), where cuffs placed around the lower legs are filled with air to help squeeze the legs and induce blood flow. However, not all patients are able to receive or tolerate IPC treatment. Another treatment which has shown promising results to prevent VTE in immobile patients after stroke, is with a medical device called the geko™ device. The geko™ device is a CE marked medical device which means the manufacturer has checked that the device complies with the essential safety and performance requirements for its' intended use which is to increase blood circulation to help prevent VTE. The aim of this study is to determine if the geko™ device is more effective at preventing VTE in immobile acute stroke patients, than the current IPC standard of care treatment. Following the consent process, stroke patients will be randomised to receive either IPC or geko device. Both devices will be applied until the patient can walk again without help, or for a maximum of 30 days. A compression Doppler exam of the legs will be conducted after 7 days or at discharge if the patient recovers earlier (optional) and after 14 days (mandatory). At 14 days post-randomisation, a patient questionnaire about the comfort of the device, as well as additional health information will be collected. At 30 days after randomisation, additional information about symptomatic DVTs or PEs etc., will be collected from the participant's medical notes. A final follow-up will then be conducted over the phone after 90 days to find out about the patient's recovery, health, mobility and quality of life.

Вмешательства

• Устройство geko™ device
  Neuromuscular electrical stimulation of the peroneal nerve

Первичные конечные точки

• Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE). [Срок оценки: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.]

Вторичные конечные точки (9)

• Device Acceptability [Срок оценки: At 14 days after randomisation]
• Device effectiveness [Срок оценки: At 30 days after randomisation]
• Leg pain level using a Numerical Rating Scale (NRS) score [Срок оценки: At 90 days after randomisation]
• Disability using the modified Rankin score [Срок оценки: At 90 days after randomisation]
• Health related quality of life using EQ-5D-5L [Срок оценки: At 90 days after randomisation]
• Patient survival [Срок оценки: At 90 days after randomisation]
• Assessment of any symptomatic or asymptomatic DVT or PE [Срок оценки: At 90 days after randomisation]
• Adverse Event Assessments [Срок оценки: Up to 30 days after randomisation or discharge, whichever comes earlier]
• NIH Stroke Scale/Score (NIHSS) [Срок оценки: At 7 days (optional/if practical) and 14 days after randomisation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Великобритания · 18 центров

• West Suffolk Hospital — Bury St Edmunds
• Royal United Hospital — Bath
• Queen Elizabeth Hospital Birmingham — Birmingham
• The Royal Bournemouth Hospital — Bournemouth
• Fairfield General Hospital — Bury
• Addenbrooke's Hospital — Cambridge
• Kent and Canterbury Hospital — Canterbury
• Countess of Chester Hospital — Chester
• … и ещё 10 центров

Идентификаторы

NCT: NCT05476913 · FSK-VTE-001 · ISRCTN11175235

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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