DISTINCT: inDividual, targeted thrombosIS prophylaxis versus the standard ‘one size fits all’ approach in patients undergoing Total hIp or total kNee replaCemenT: a national, multicenter, randomized, multi-arm, open-label trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10,078
- 试验地点
- 14
- 主要终点
- Number of VTEs in the first 3 months postoperative
研究概览
简要总结
DISTINCT 1: to determine whether in-hospital thrombosis prophylaxis only is as effective compared with the standard thrombosis prophylaxis approach to prevent symptomatic VTE after total knee and hip arthroplasty in patients with a low VTE risk. DISTINCT 2: to determine the incidence of symptomatic VTE after total knee and hip arthroplasty in patients with an intermediate VTE risk. DISTINCT 3: to determine whether intensified thrombosis prophylaxis is more effective and equally safe compared with standard thrombosis prophylaxis to prevent symptomatic VTE in patients with a high VTE risk by comparing symptomatic VTE and bleeding complications.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled to undergo an elective Total Hip Arthroplasty or Total Knee Arthroplasty
- •Subjects aged 18 years or older
排除标准
- •Primary arthroplasty for fractures
- •Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician
- •Revision surgery
- •Hemiarthroplasty
- •Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)
- •A contraindication for either study drug
- •Insufficient knowledge of the Dutch language
- •Insufficient mental or physical ability to fulfil trial requirements
- •Active malignancy (i.e. cancer diagnosis within six months before surgery (excluding basal-cell or squamous-cell carcinoma of the skin), recently recurrent or progressive cancer or any cancer that required anti-cancer treatment within six months before surgery)
结局指标
主要结局
Number of VTEs in the first 3 months postoperative
Number of VTEs in the first 3 months postoperative
Number of major bleeds in the first 3 months postoperative.
Number of major bleeds in the first 3 months postoperative.
次要结局
- Clinically relevant non major bleeding
- Impact of events on QALY’s
- Healthcare costs
- Prosthetic joint infections
- Patient reported outcome measures
- Myocardial infarction
- Ischemic stroke
- Death
研究者
Study team DISTINCT trial
Scientific
Academisch Ziekenhuis Leiden