The DISTINCT Trial: 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.

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty

• Aged 18 years or older

Locations
Other Locations
Netherlands
OLVG
RECRUITING
Amsterdam
Gelre Ziekenhuizen
RECRUITING
Apeldoorn
Anna Ziekenhuis
RECRUITING
Geldrop
Zuyderland
RECRUITING
Geleen
Alrijne
RECRUITING
Leiderdorp
Bergman Clinics
RECRUITING
Naarden
Bravis ziekenhuis
NOT_YET_RECRUITING
Roosendaal
Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
Reinier Haga Orthopedisch Centrum
RECRUITING
Zoetermeer
Isala ziekenhuis
RECRUITING
Zwolle
Contact Information
Primary
Banne Nemeth, dr
B.Nemeth@lumc.nl
+31715264037
Backup
Ruben Y Kok, drs
R.Y.Kok@lumc.nl
+31715265633
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2031-02-01
Participants
Target number of participants: 10078
Treatments
Experimental: DISTINCT 1 short duration prophylaxis
Patients with a low VTE risk (predicted 3-months postoperative VTE risk \<1%) based on the TRiP(plasty) score. (Nemeth, 2024)
Active_comparator: DISTINCT 1 control
Patients with a low VTE risk (predicted 3-months postoperative VTE risk \<1%) based on the TRiP(plasty) score. (Nemeth, 2024)
Other: DISTINCT 2 observational arm
Patients with an intermediate VTE risk (predicted 3-months postoperative VTE risk ≥1%-≤1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
Experimental: DISTINCT 3 extended prophylaxis
Patients with a high VTE risk (predicted 3-months postoperative VTE risk \>1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
Active_comparator: DISTINCT 3 control
Patients with a high VTE risk (predicted 3-months postoperative VTE risk \>1.5%) based on the TRiP(plasty) score. (Nemeth, 2024)
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov