inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
Recruiting now · Phase 4
Conditions studied: Venous Thromboembolism, Venous Thromboses, Pulmonary Embolism, Deep Vein Thrombosis
In brief
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.
Key facts
- Study ID
- NCT06581965
- Run by
- Leiden University Medical Center
- People needed
- 10078
- Starts
- 2024-11-11
- Expected to finish
- 2031-02-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
- Aged 18 years or older
You may not qualify if…
- 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
Where it is running
- Reinier Haga Orthopedisch Centrum — Zoetermeer, South Holland, Netherlands (enrolling)
- Zuyderland — Geleen, Limburg, Netherlands (enrolling)
- Anna Ziekenhuis — Geldrop, North Brabant, Netherlands (enrolling)
- Gelre Ziekenhuizen — Apeldoorn, Gelderland, Netherlands (enrolling)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, North Brabant, Netherlands (enrolling)
- OLVG — Amsterdam, North Holland, Netherlands (enrolling)
- Bergman Clinics — Naarden, North Holland, Netherlands (enrolling)
- Isala ziekenhuis — Zwolle, Overijssel, Netherlands (enrolling)
- Alrijne — Leiderdorp, South Holland, Netherlands (enrolling)
- Bravis ziekenhuis — Roosendaal, North Brabant, Netherlands
Full record on ClinicalTrials.gov
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