Personalized Blood Clot Prevention Compared to Standard Treatment After Total Hip or Knee Replacement Surgery A National Multicenter Phase 4 Trial

What this Trial Is About

Researchers are evaluating whether customizing blood thinner treatment after hip or knee replacement surgery can reduce both blood clots and bleeding compared to the standard approach used for all patients. This study focuses on patients undergoing elective total hip or knee arthroplasty and aims to determine if shorter treatment is safe for low-risk patients and if higher doses for high-risk patients lower clot risks without causing too much bleeding. Participants are grouped based on their predicted risk of venous thromboembolism VTE using a risk score called TRiPplasty. Low-risk patients are randomly assigned to either a shortened prophylaxis during hospital stay only or standard treatment for about 4 weeks. High-risk patients are randomly assigned to receive intensified and extended prophylaxis for 6 weeks or standard treatment. Intermediate-risk patients participate in an observational arm without treatment changes. Treatments include types of blood thinners such as low molecular weight heparin or direct oral anticoagulants given according to Dutch guidelines. During the study, participants complete four questionnaires one before surgery, and at 2 weeks, 6 weeks, and 3 months after surgery to assess blood clots and bleeding events. An additional questionnaire at 1 year evaluates quality of life and joint function for those who experienced complications or a matched group. No extra hospital visits are required. Researchers will measure rates of venous thromboembolic events and major bleeding within 90 days, along with other health outcomes and patient-reported quality of life.

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