ACTRN12622001527752招募中未知
Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thrombo-embolic events: a randomised clinical trial in patients undergoing surgery
niversity of Newcastle0 个研究点目标入组 4,130 人开始时间: 2022年12月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 4,130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patient undergoing elective major surgery with major surgery defined as any operation deemed by the surgical team to be requiring admission to hospital beyond 24 hours
- •>18 years of age
- •Moderate or high risk of venous thromboembolism (VTE) based on NSW risk assessment form
排除标准
- •Are unable to give written informed consent to take part in the study
- •are not expected to be ambulant within 24 hours
- •Have contraindications to LMWH
- •Have contraindications to GCS or IPCDs
- •Have had previous heparin-induced thrombocytopenia/thrombosis (HITT)
- •are undergoing lower leg surgery (orthopaedics)
- •Have active, clinically significant bleeding (Class 2 and above) i.e. volume loss of 15% to over 40% of total blood volume.
- •Have documented congenital or acquired bleeding tendency/disorders
- •Have had a recent intracranial haemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery
- •Have epidural or spinal anaesthesia planned
- •Have active peptic ulcer or treatment of same in the last three months
- •Have severe liver disease (Liver cirrhosis)
- •Have current thrombocytopenia e.g., platelets <70
- •Have renal Impairment GFR <30 and or creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participant
- •Are pregnant and/or breastfeeding women
- •Have evidence of leg ischemia caused by peripheral vascular disease (previously documented or on clinical assessment)
- •Have clinical signs of VTE and/or a history of VTE- Pulmonary embolism, Deep vein thrombosis
- •Have pre-existing indications for heparins (including LMWH). These are people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks ie Atrial fibrillation, Pulmonary hypertension, Cardiomyopathy, Ischemic stroke, Certain congenital heart disorders, Artificial valve replacement
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