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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 36
- 主要终点
- Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The trial will be single blind for the primary outcome. Devices will be taken off before participants have Doppler imaging at 7 days and 14 days. Data on VTE will be taken by a blinded researcher using information available on hospital information systems.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Single or double leg amputations
结局指标
主要结局
Frequency of any symptomatic or asymptomatic Deep Vein Thrombosis (DVT) in the calf, popliteal or femoral veins or any Pulmonary Embolism (PE).
时间窗: From randomisation to 30 days. Compression Dopplers at 7 d (optional) and 14 d after randomisation.
Determine the number of patients diagnosed to have a VTE (DVT and PE), comparing the two groups: geko™ device compared to IPC standard of care. Asymptomatic DVT will be diagnosed using above knee compression Doppler (Compression Duplex Ultrasound) and PE will be diagnosed using ventilation perfusion scan or by computer tomography pulmonary angiogram (CTPA). Compression Dopplers will be conducted any time there is a clinical suspicion of DVT. Above knee compression Dopplers will be conducted at 7 days and 14 days after randomisation, or at patient discharge if patient recovers earlier than 7 d and 14 days post-randomisation.
次要结局
- Device Acceptability(At 14 days after randomisation)
- Device effectiveness(At 30 days after randomisation)
- Leg pain level using a Numerical Rating Scale (NRS) score(At 90 days after randomisation)
- Disability using the modified Rankin score(At 90 days after randomisation)
- Assessment of any symptomatic or asymptomatic DVT or PE(At 90 days after randomisation)
- Patient survival(At 90 days after randomisation)
- Adverse Event Assessments(Up to 30 days after randomisation or discharge, whichever comes earlier)
- NIH Stroke Scale/Score (NIHSS)(At 7 days (optional/if practical) and 14 days after randomisation)
- Health related quality of life using EQ-5D-5L(At 90 days after randomisation)