Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Venous Thromboembolic Events (VTE)
研究概览
简要总结
Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments.
This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.
详细描述
The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines.
Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute unilateral Achilles tendon rupture or isolated Ankle Fracture
- •Treatment starts within 10 days in a hospital setting
排除标准
- •Inability or refusal to give informed consent for participation in the study
- •Inability to comply with the study instructions
- •Known kidney disorder
- •Heart failure with pitting oedema
- •Presence of known malignancy
- •Current bleeding disorder
- •Pregnancy
- •Planned follow-up at another hospital
- •Pilon fracture
研究组 & 干预措施
Leg Immobilization
Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Adjuvant IPC
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
干预措施: Adjuvant IPC (Device)
结局指标
主要结局
Venous Thromboembolic Events (VTE)
时间窗: Up til the time of removal of leg immobilization, approx. 6-8 weeks
The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
次要结局
- Patient reported Outcome - EQ-5D-5L(6 months and 1 year)
- Health economic analyses(2 years)
- Patient reported Outcome - ATRS(6 months and 1 year)
- Patient reported Outcome - FAOS(6 months and 1 year)
- Patient reported Outcome - OMAS(6 months and 1 year)
- Functional outcome - muscular endurance tests (heel-rise)(1 year)
- Patient mortality(1year and 2 years)
- VTE-preventive mechanisms(6 weeks)
- Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC(6-8 weeks)
- Callus production(6 weeks)
研究者
Paul Ackermann
Professor, MD, PhD
Karolinska University Hospital