Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06581965

inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT

Led by Leiden University Medical Center · Updated on 2025-09-03

10078

Participants Needed

10

Research Sites

324 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
  • Aged 18 years or older
Not Eligible

You will not qualify if you...

  • 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 (cancer diagnosis within six months before surgery, excluding basal-cell or squamous-cell carcinoma of the skin, recent recurrent or progressive cancer, or cancer requiring treatment within six months before surgery)
  • Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Gelre Ziekenhuizen

Apeldoorn, Gelderland, Netherlands, 7334 DZ

Actively Recruiting

2

Zuyderland

Geleen, Limburg, Netherlands, 6162 BG

Actively Recruiting

3

Anna Ziekenhuis

Geldrop, North Brabant, Netherlands, 5564EH

Actively Recruiting

4

Bravis ziekenhuis

Roosendaal, North Brabant, Netherlands, 4708 AE

Not Yet Recruiting

5

Elisabeth-TweeSteden Ziekenhuis

Tilburg, North Brabant, Netherlands, 5022GC

Actively Recruiting

6

OLVG

Amsterdam, North Holland, Netherlands, 1091AC

Actively Recruiting

7

Bergman Clinics

Naarden, North Holland, Netherlands, 1411DE

Actively Recruiting

8

Isala ziekenhuis

Zwolle, Overijssel, Netherlands, 8025AB

Actively Recruiting

9

Alrijne

Leiderdorp, South Holland, Netherlands, 2353 GA

Actively Recruiting

10

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, Netherlands, 2725NA

Actively Recruiting

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Research Team

B

Banne Nemeth, dr

CONTACT

R

Ruben Y Kok, drs

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

5

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