DISTINCT: inDividual, targeted thrombosIS prophylaxis versus the standard ‘one size fits all’ approach in patients undergoing Total hIp or total kNee replaCemenT: a national, multicenter, randomized, multi-arm, open-label trial
- Conditions
- Venous thromboembolismTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-510186-98-00
- Lead Sponsor
- Academisch Ziekenhuis Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10078
Subjects scheduled to undergo an elective Total Hip Arthroplasty or Total Knee Arthroplasty, Subjects aged 18 years or older
Primary arthroplasty for fractures, Patients using thrombocyte aggregation inhibitors that cannot be temporarily discontinued at the discretion of their treating physician, 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method