Status:
RECRUITING
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
Lead Sponsor:
Leiden University Medical Center
Conditions:
Venous Thromboembolism
Venous Thromboses
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 individ...
Detailed Description
Background Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are associated with an overall symptomatic venous thromboembolism (VTE) risk of about 1.3% despite the use of prophylactic an...
Eligibility Criteria
Inclusion
- Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty
- Aged 18 years or older
Exclusion
- 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
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
10078 Patients enrolled
Trial Details
Trial ID
NCT06581965
Start Date
November 11 2024
End Date
February 1 2031
Last Update
September 3 2025
Active Locations (10)
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1
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands, 7334 DZ
2
Zuyderland
Geleen, Limburg, Netherlands, 6162 BG
3
Anna Ziekenhuis
Geldrop, North Brabant, Netherlands, 5564EH
4
Bravis ziekenhuis
Roosendaal, North Brabant, Netherlands, 4708 AE