inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
NCT Number: NCT06581965
Acronym: DISTINCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Venous Thromboembolism|Venous Thromboses|Pulmonary Embolism|Deep Vein Thrombosis
Interventions: OTHER: Short duration prophylaxis|OTHER: Higher intensity and longer duration prophylaxis|OTHER: Control
Sponsor: Leiden University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10078
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2031-02-01
Locations: Bergman Clinics, Naarden, Noord-Holland, 1411DE, Netherlands|Isala ziekenhuis, Zwolle, Overijssel, 8025AB, Netherlands|Reinier Haga Orthopedisch Centrum, Zoetermeer, Zuid-Holland, 2725NA, Netherlands

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 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.

Primary Outcome Measures: Venous thromboembolic events, Number of VTEs in the first 3 months postoperative., 90 days postoperative|Major bleeding, Number of major bleeds in the first 3 months postoperative., 90 days postoperative
Secondary Outcome Measures: Clinically relevant non major bleeding, Incidence of clinically relevant non-major bleeding, 90 days postoperative|Impact of events on QALY's, Estimated using the EQ-5D-5L, 90 days and 1 year postoperative|Healthcare costs, Healthcare costs will be estimated from patient questionnaires at 0, 2, 6, 13 and 52 weeks., 90 days and 1 year postoperative|Prosthetic joint infections, Defined according to the European Bone and Joint Infection Society (EBJIS) definition of periprosthetic joint infection described in Bone Joint J 2021;103-B(1):18-25., 90 days postoperative|Patient reported quality of life, Measured using the EQ-5D-5L (scored as described in: Value in Health 2016, 19(4), 343-352.), 90 days and 1 year postoperative|Patient reported quality of life, Measured using the 36-Item Short Form Health Survey (score 0-100 with a higher score indicating a higher quality of life), 1 year postoperative|Patient reported outcome measures, Measured using Oxford Hip score or Ofxord Knee Score depending on the performed surgery. (score 0-100 with a higher score indicating a better outcome), 1 year postoperative|Myocardial infarction, Incidence of myocardial infarction, 90 days postoperative|Ischemic stroke, Incidence of ischemic stroke, 90 days postoperative|Death, Incidence of death, 90 days postoperative