RECRUITINGPhase 4INTERVENTIONAL

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

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Scheduled to undergo an elective total hip arthroplasty or total knee arthroplasty - Aged 18 years or older Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Short duration prophylaxis

Only during hospitalization: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guideline "Antitrombotisch beleid". First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use (same type as used for control group).

OTHER

Higher intensity and longer duration prophylaxis

The use of any thrombocyte aggregation inhibitors should be discontinued 5 days prior to surgery. Day 0-2: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use. Day 3: Apixaban 5mg b.i.d., continued until 6 weeks after surgery, conditional on the fact that no active bleeding of the surgical wound can be observed. In case of active bleeding, the prophylactic dose of thrombosis prophylaxis is continued. Thereafter, in case no active bleeding has been observed for 24 hours, the 5mg b.i.d. apixaban treatment will be started. The 5mg b.i.d. apixaban dose will be adjusted to 2.5mg b.i.d. in case of an impaired kidney function (defined as eGFR 10-30ml/min).

OTHER

Control

4 weeks: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use.

Locations (10)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, Netherlands

Zuyderland

Geleen, Limburg, Netherlands

Anna Ziekenhuis

Geldrop, North Brabant, Netherlands

Bravis ziekenhuis

Roosendaal, North Brabant, Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, North Brabant, Netherlands

OLVG

Amsterdam, North Holland, Netherlands

Bergman Clinics

Naarden, North Holland, Netherlands

Isala ziekenhuis

Zwolle, Overijssel, Netherlands

Alrijne

Leiderdorp, South Holland, Netherlands

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, Netherlands