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Leiden Thrombosis Recurrence Risk Prevention
Sponsor: Leiden University Medical Center
Summary
The goal of this clinical trial is to evaluate tailored duration of long-term anticoagulant treatment after a first venous thromboembolism based on individualized risk assessments of recurrent VTE and major bleeding risks. Participants will be asked to fill in a questionnaire and take a buccal swab, which are used for an individual estimation of the risks of recurrent VTE and bleeding. Based on these risks a treatment advise will be made, or randomised in a subgroup of patients.
Official title: Leiden Thrombosis Recurrence Risk Prevention: Tailored Treatment After a First Venous Thromboembolism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
608
Start Date
2021-06-18
Completion Date
2027-06-01
Last Updated
2026-02-20
Healthy Volunteers
No
Interventions
Randomised treatment advice (discontinue vs continue after 3 months)
Randomisation to continue or discontinue anticoagulant therapy in 1:1 ratio stratified on risk category of L-TRRiP and VTE-BLEED score
VTE-BLEED score
Predict bleeding risk during extended anticoagulant treatment (high or low) using the VTE-BLEED score
L-TRRiP score
Predict VTE recurrence risk after anticoagulant discontinuation (high, intermediate or low) using the L-TRRiP score
Advise to continue anticoagulant treatment after 3 months
Advise to continue anticoagulant treatment after 3 months for patients with high VTE recurrence and low bleeding risk
Advise to discontinue anticoagulant treatment after 3 months
Advise to discontinue anticoagulant treatment after 3 months for patients with low VTE recurrence risk
Locations (19)
Leiden University Medical Center
Leiden, South Holland, Netherlands
Amsterdam Medical Center, location AMC
Amsterdam, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Nij Smellinghe Ziekenhuis
Drachten, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Isala Klinieken
Zwolle, Netherlands