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Taking peoplePhase 4

Tailored blood clot prevention after hip or knee replacement surgery

Tests shorter or longer blood thinner use by clot risk after joint replacement.

Key facts

Who runs it
Leiden University Medical Center
Where
Netherlands16 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
Status
Recruiting
Phase
Phase 4
People taking part
10,078 people, planned
Started
11 Nov 2024
Expected to end
1 Feb 2031
Type of study
Interventional, 5 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Short duration prophylaxis
  • Higher intensity and longer duration prophylaxis
  • Control
Record updated
8 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are planned to have a total hip or total knee replacement. It tests blood thinner treatment after surgery adjusted to each person's clot risk.

Age
18 years or older
Sex
All sexes can join
Disease stage
Planned (elective) total hip or total knee replacement. Replacement after a fracture, repeat (revision) surgery or partial hip replacement (hemiarthroplasty) cannot join.
Earlier treatment
People who currently take full-dose blood thinners of any type (e.g., LMWH, DOAC, vitamin K antagonist) cannot join.

Main reasons for not taking part

  • Pregnancy
  • Current use of full-dose blood thinners, or a reason you cannot take either study drug
  • Active cancer: diagnosed, returned, growing or treated within six months before surgery (except basal-cell or squamous-cell skin cancer)
  • Taking platelet-blocking drugs (thrombocyte aggregation inhibitors) that the doctor cannot pause for a while
  • Not enough knowledge of the Dutch language, or not mentally or physically able to follow the trial

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
  • Aged 18 years or older

Who cannot take part

  • Revision surgery
  • Current use of therapeutic anticoagulant therapy of any type (e.g., LMWH, DOAC, vitamin K antagonist)
  • A contraindication for either study drug
  • 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
  • Primary arthroplasty for fractures
  • Hemiarthroplasty
  • Pregnancy
  • Insufficient knowledge of the Dutch language
  • Insufficient mental or physical ability to fulfil trial requirements

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 5 groups in the trial

  • DISTINCT 1 short duration prophylaxisTreatment being tested

    Patients with a low VTE risk (predicted 3-months postoperative VTE risk \<1%) based on the TRiP(plasty) score. (Nemeth, 2024)

    Treatment: Short duration prophylaxis

  • DISTINCT 1 controlExisting treatment, for comparison

    Patients with a low VTE risk (predicted 3-months postoperative VTE risk \<1%) based on the TRiP(plasty) score. (Nemeth, 2024)

    Treatment: Control

  • DISTINCT 2 observational armOther group

    Patients with an intermediate VTE risk (predicted 3-months postoperative VTE risk ≥1%-≤1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)

    Treatment: Control

  • DISTINCT 3 extended prophylaxisTreatment being tested

    Patients with a high VTE risk (predicted 3-months postoperative VTE risk \>1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)

    Treatment: Higher intensity and longer duration prophylaxis

  • DISTINCT 3 controlExisting treatment, for comparison

    Patients with a high VTE risk (predicted 3-months postoperative VTE risk \>1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)

    Treatment: Control

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tailored blood clot prevention after hip or knee replacement surgeryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Publications
Record updated
8 September 2026