Personalized blood thinner treatment for hip and knee replacement patients
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.
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 |
| Enrollment | 10078 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 10 sites (Apeldoorn, Gelderland and 9 other locations) |
| Trial ID | NCT06581965 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective total hip or knee arthroplasty.
Not a fit: Patients undergoing revision surgeries, those with active malignancies, or individuals currently on therapeutic anticoagulant therapy may not benefit from this study.
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 performed: Previous studies have shown promise in individualized anticoagulation strategies, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Apeldoorn, Gelderland and 9 other locations
- Gelre Ziekenhuizen — Apeldoorn, Gelderland, Netherlands (Recruiting)
- Zuyderland — Geleen, Limburg, Netherlands (Recruiting)
- Anna Ziekenhuis — Geldrop, North Brabant, Netherlands (Recruiting)
- Bravis ziekenhuis — Roosendaal, North Brabant, Netherlands (Not_yet_recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, North Brabant, Netherlands (Recruiting)
- Olvg — Amsterdam, North Holland, Netherlands (Recruiting)
- Bergman Clinics — Naarden, North Holland, Netherlands (Recruiting)
- Isala ziekenhuis — Zwolle, Overijssel, Netherlands (Recruiting)
- Alrijne — Leiderdorp, South Holland, Netherlands (Recruiting)
- Reinier Haga Orthopedisch Centrum — Zoetermeer, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Banne Nemeth, dr — Leiden University Medical Center
- Study coordinator: Banne Nemeth, dr
- Email: B.Nemeth@lumc.nl
- Phone: +31715264037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.