Personalized blood thinner treatment for hip and knee replacement patients
Official title: 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.
Run by Leiden University Medical Center · NCT06581965 · Data updated 2026-11-12
This study is testing if personalized blood thinner treatments can better prevent blood clots and bleeding in patients getting hip or knee replacements compared to standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10078 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 13 sites (Apeldoorn, Gelderland and 12 other locations) |
| Status | Recruiting |
| Started | November 11, 2024 |
| Main results expected | May 1, 2030 |
| Study ends | February 1, 2031 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT06581965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older scheduled for elective total hip or knee arthroplasty.
✕Probably not a fit
Patients undergoing revision surgeries, those with active malignancies, or individuals currently on therapeutic anticoagulant therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of individualized thrombosis prophylaxis compared to standard treatment in patients undergoing total hip or knee replacement. It aims to determine if shorter or intensified anticoagulation strategies can reduce the risk of venous thromboembolism (VTE) and bleeding complications based on a patient's specific risk profile. By tailoring the duration and intensity of blood thinner treatment, the study seeks to optimize patient outcomes and minimize unnecessary risks. The research involves comparing different prophylaxis approaches in a diverse patient population.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective prevention of blood clots for patients undergoing joint replacement surgeries.
How similar studies have gone: Previous studies have shown promise in individualized anticoagulation strategies, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty * Aged 18 years or older Exclusion Criteria: * 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
Where it's running
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Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands Recruiting -
Zuyderland
Geleen, Limburg, Netherlands Recruiting -
Anna Ziekenhuis
Geldrop, North Brabant, Netherlands Recruiting -
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, Netherlands Recruiting -
Olvg
Amsterdam, North Holland, Netherlands Recruiting -
Bergman Clinics
Naarden, North Holland, Netherlands Recruiting
Show 7 more locations
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Isala ziekenhuis
Zwolle, Overijssel, Netherlands Recruiting -
Alrijne
Leiderdorp, South Holland, Netherlands Recruiting -
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, Netherlands Recruiting -
St. Antonius Ziekenhuis
Utrecht, Utrecht, Netherlands Recruiting -
ZorgSaam
Terneuzen, Zeeland, Netherlands Recruiting -
Groene Hart Ziekenhuis
Gouda, Netherlands Recruiting -
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Banne Nemeth, dr — Leiden University Medical Center
- Study coordinator: Banne Nemeth, dr
- Email: B.Nemeth@lumc.nl
- Phone: +31715264037
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.