학술논문
Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial
Document Type
article
Author
Saskia le Cessie; Nick van Es; Michiel Coppens; Karina Meijer; Suzanne C Cannegieter; Saskia Middeldorp; Menno V Huisman; Frederikus A Klok; Geert-Jan Geersing; Annette W G van der Velden; Elske M van den Akker-van Marle; Albert T A Mairuhu; M Elske van den Akker-van Marle; Laura M Faber; Tjerk de Nijs; Remy H H Bemelmans; Coen van Guldener; Marcel A van de Ree; Marieke J.H. Wermer; Tessa Elling; Carolien van Netten; Milou A M Stals; Rick Roos; J Louise I Burggraaf-van Delft; Nienke van Rein; Jan-Willem K van den Berg; Coty Y Bruggeman; Marissa Cloos-van Balen; Matthijs Eefting; Yvonne Ende-Verhaar; Wouter K de Jong; Fleur Kleijwegt; Ted Koster; Cees Kroon; Saskia Kuipers; Jenneke Leentjens; Dieuwke Luijten; Ilse Schrover; Janneke Swart-Heikens; Yavuz Bilgin; Marleen Goddrie; Pieter Jobse; Suzanne Jong; Brianne Murphy; Carla Boekholt; Danick Werner; Laura Kratz; Marjolein Kremers; Monique Schilders; Gideon Hajer; Bas Langeveld; Saskia Teunisse-de Recht; Annemiek Bogerd; Ymke Broers; Stan Kolman; Sanjay Sankatsing; Lenneke van Tol; Edith Beishuizen; Shantie Bharatsingh; Edith Boersma; Annemarie van der Kraan-Donker; Sabine van Arnhem; Fransien Croon-de Boer; Ad Dees; J P (Hanneke) van Embden; Roxane Heller; Merel Hoogendorp; Roel Jonkhoff; Roel J J M van de Laar; Corry Leunis-de Ruiter; Patricia Scherpenisse-Klopstra; Tom L H Stellema; Kim Warink; Lizanne E van den Akker; Eleonora C Camilleri; Tess R C Huibregtse; Ingeborg de Jonge; Ruben Y Kok; Inger N Kunnekes; Lejla Mahic; Hinke C Nagtegaal; Petra J Noordijk; Hülya Oztürk; Alexia M van der Ploeg; Vibeke Schmidt; Anne-Marie Schuitemaker; Vera C Slootweg; Mark J R Smeets; Milou Thibaudier; Marco Dam; Swopkje de Jong; Hanneke van der Velde; Evertine Abbink; Carlinda Bresser; Simone Sissing; Soerajja Bhoelan; Èmese Heijkoop; Francien Huisman; Mark Lenssen; Anja B U Makelburg; Karen H Thedinga; Marja A J Voskuilen; Femke Yspeerd; Sandra Brookman; Titia Lamberts; Inge Paas; Janneke Swart Heikens; Janneke van den Brink; Aline van de Vendel; Ellis S. van Etten
Source
BMJ Open, Vol 14, Iss 3 (2024)
Subject
Language
English
ISSN
2044-6055
Abstract
Introduction Patients with a first venous thromboembolism (VTE) are at risk of recurrence. Recurrent VTE (rVTE) can be prevented by extended anticoagulant therapy, but this comes at the cost of an increased risk of bleeding. It is still uncertain whether patients with an intermediate recurrence risk or with a high recurrence and high bleeding risk will benefit from extended anticoagulant treatment, and whether a strategy where anticoagulant duration is tailored on the predicted risks of rVTE and bleeding can improve outcomes. The aim of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study is to evaluate the outcomes of tailored duration of long-term anticoagulant treatment based on individualised assessment of rVTE and major bleeding risks.Methods and analysis The L-TRRiP study is a multicentre, open-label, cohort-based, randomised controlled trial, including patients with a first VTE. We classify the risk of rVTE and major bleeding using the L-TRRiP and VTE-BLEED scores, respectively. After 3 months of anticoagulant therapy, patients with a low rVTE risk will discontinue anticoagulant treatment, patients with a high rVTE and low bleeding risk will continue anticoagulant treatment, whereas all other patients will be randomised to continue or discontinue anticoagulant treatment. All patients will be followed up for at least 2 years. Inclusion will continue until the randomised group consists of 608 patients; we estimate to include 1600 patients in total. The primary outcome is the combined incidence of rVTE and major bleeding in the randomised group after 2 years of follow-up. Secondary outcomes include the incidence of rVTE and major bleeding, functional outcomes, quality of life and cost-effectiveness in all patients.Ethics and dissemination The protocol was approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft. Results are expected in 2028 and will be disseminated through peer-reviewed journals and during (inter)national conferences.Trial registration number NCT06087952.