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

RecruitingPhase 4Ages 18 Years - anyAllLeiden University Medical Center
NCT06581965 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
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
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What it tests

  • Short duration prophylaxis
  • Higher intensity and longer duration prophylaxis
  • Control
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Where

13 sites
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Zuyderland
Geleen, Netherlands
Anna Ziekenhuis
Geldrop, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
OLVG
Amsterdam, Netherlands
Bergman Clinics
Naarden, Netherlands
Isala ziekenhuis
Zwolle, Netherlands
Alrijne
Leiderdorp, Netherlands

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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