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Search / Trial NCT06581965

InDividual, Targeted ThrombosIS Prophylaxis Versus the Standard 'one Size Fits All' Approach in Patients Undergoing Total HIp or Total KNee ReplaCemenT

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Aug 29, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Venous Thromboembolism Prophylaxis Individualized Medicine Total Hip Arthroplasty Total Knee Arthroplasty Randomized Controlled Trial

ClinConnect Summary

This clinical trial is looking at how to customize blood thinner treatment for patients who are having total hip or knee replacements. After these surgeries, patients usually receive a standard blood thinner to prevent blood clots, but some people still develop clots or face bleeding issues. The study aims to determine if patients who are at low risk for blood clots can safely have a shorter treatment, which might help reduce bleeding. Conversely, for those at higher risk, the trial will explore if increasing the dose and length of treatment can better prevent clots without causing too much bleeding.

To participate, you need to be at least 18 years old and scheduled for an elective hip or knee replacement. The trial is currently looking for volunteers and does not require extra hospital visits; instead, participants will complete four questionnaires to track their health outcomes. This study is important because it could lead to more effective and safer blood thinner treatments tailored to individual patient needs.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
  • Aged 18 years or older
  • Exclusion Criteria:
  • 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

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Amsterdam, Noord Holland, Netherlands

Naarden, Noord Holland, Netherlands

Zwolle, Overijssel, Netherlands

Zoetermeer, Zuid Holland, Netherlands

Geldrop, Noord Brabant, Netherlands

Tilburg, Noord Brabant, Netherlands

Patients applied

0 patients applied

Trial Officials

Banne Nemeth, dr

Principal Investigator

Leiden University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported