The DISTINCT Trial: 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
- 发起方
- 入组人数
- 10,078
- 试验地点
- 24
- 主要终点
- Venous thromboembolic events
研究概览
简要总结
After hip or knee replacement all patients receive a standardized treatment with blood thinners, this medication is called thrombosis prophylaxis. However, despite this standard treatment some individuals still develop venous thrombosis (VTE), while others experience bleeding. This indicates that not all patients have the same VTE risk following surgery. Individualizing the amount of thrombosis prophylaxis following surgery might lead to less thrombotic and bleeding events. In this study the investigators individualize the treatment with thrombosis prophylaxis based on the medical history of a patient.
The main questions this study aims to answer are:
Can thrombosis prophylaxis be shortened in patients with a low VTE risk to decrease the risk of bleeding without increasing the risk of VTE? Does an increase in the dose and duration of thrombosis prophylaxis in patients with a high VTE risk reduce the risk of VTE without inducing an unacceptable risk of bleeds?
Researchers will compare both the shortened treatment in low VTE risk patients and the intensified and extended treatment in high VTE risk patients with the standard treatment to assess the risk of VTE and bleeding in comparison to the standard treatment.
Participants will receive 4 questionnaires to evaluate whether they have experienced a VTE or bleed. For this study no additional hospital visits are necessary.
详细描述
Background
Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are associated with an overall symptomatic venous thromboembolism (VTE) risk of about 1.3% despite the use of prophylactic anticoagulants in all patients. While not preventing all VTEs, the uniform application of anticoagulant prophylaxis is at the same time associated with a major bleeding risk of at least 0.5%. Considering that a large proportion of all patients actually have a low VTE risk, this group is unnecessarily exposed to the burden and risks of thrombosis prophylaxis. On the contrary, some patients with a high VTE risk experience a VTE despite the use of the same prophylactic anticoagulants. These VTE cases could have possibly been prevented by intensified prophylaxis.
Objectives
Overall objective: To study whether the application of a targeted anticoagulation strategy leads to less thrombotic and bleeding complications in this large patient group.
Primary objective DISTINCT study arm 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.
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
- None
盲法说明
Blinded endpoint adjudication
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
- •Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
- •Aged 18 years or older
排除标准
- •Primary arthroplasty for fractures
- •Revision surgery
- •Hemiarthroplasty
- •Pregnancy
- •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)
- •Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician
研究组 & 干预措施
DISTINCT 3 extended prophylaxis
Patients with a high VTE risk (predicted 3-months postoperative VTE risk >1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
干预措施: Higher intensity and longer duration prophylaxis (Other)
DISTINCT 3 control
Patients with a high VTE risk (predicted 3-months postoperative VTE risk >1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
干预措施: Control (Other)
DISTINCT 1 short duration prophylaxis
Patients with a low VTE risk (predicted 3-months postoperative VTE risk <1%) based on the TRiP(plasty) score. (Nemeth, 2024)
干预措施: Short duration prophylaxis (Other)
DISTINCT 1 control
Patients with a low VTE risk (predicted 3-months postoperative VTE risk <1%) based on the TRiP(plasty) score. (Nemeth, 2024)
干预措施: Control (Other)
DISTINCT 2 observational arm
Patients with an intermediate VTE risk (predicted 3-months postoperative VTE risk ≥1%-≤1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
干预措施: Control (Other)
结局指标
主要结局
Venous thromboembolic events
时间窗: 90 days postoperative
Number of VTEs in the first 3 months postoperative.
Major bleeding
时间窗: 90 days postoperative
Number of major bleeds in the first 3 months postoperative.
次要结局
- Clinically relevant non major bleeding(90 days postoperative)
- Impact of events on QALY's(90 days and 1 year postoperative)
- Healthcare costs(90 days and 1 year postoperative)
- Prosthetic joint infections(90 days postoperative)
- Patient reported quality of life(1 year postoperative)
- Patient reported outcome measures(1 year postoperative)
- Myocardial infarction(90 days postoperative)
- Ischemic stroke(90 days postoperative)
- Death(90 days postoperative)
研究者
B.Nemeth
Postdoctoral researcher Clinical epidemiology
Leiden University Medical Center