Authorised Therapeutic use (Phase IV) Venous thromboembolism

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

EU CTIS ID: 2023-510186-98-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Subjects scheduled to undergo an elective Total Hip Arthroplasty or Total Knee Arthroplasty
  • Subjects aged 18 years or older

You likely can't join if

  • Primary arthroplasty for fractures
  • Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician
  • Revision surgery
  • Hemiarthroplasty
  • Pregnancy
  • Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)
See the full eligibility criteria
Who can join
  • Subjects scheduled to undergo an elective Total Hip Arthroplasty or Total Knee Arthroplasty
  • Subjects aged 18 years or older
What rules you out
  • Primary arthroplasty for fractures
  • Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician
  • 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)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.