Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
- Aged 18 years or older
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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