Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial

IntroductionPatients 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...

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Veröffentlicht in:BMJ open 2024-03, Vol.14 (3), p.e078676
Hauptverfasser: Burggraaf-van Delft, J Louise I, Bemelmans, Remy H H, van den Berg, Jan-Willem K, Bruggeman, Coty Y, Cloos-van Balen, Marissa, Coppens, Michiel, Eefting, Matthijs, Ende-Verhaar, Yvonne, van Es, Nick, van Guldener, Coen, Kleijwegt, Fleur, Koster, Ted, Kroon, Cees, Kuipers, Saskia, Leentjens, Jenneke, Luijten, Dieuwke, Meijer, Karina, van de Ree, Marcel A, Roos, Rick, Swart-Heikens, Janneke, van der Velden, Annette W G, le Cessie, Saskia, Geersing, Geert-Jan, Klok, Frederikus A, Cannegieter, Suzanne C, Bilgin, Yavuz, Goddrie, Marleen, Jobse, Pieter, Murphy, Brianne, Netten, Carolien van, Werner, Danick, Kremers, Marjolein, Schilders, Monique, Hajer, Gideon, Teunisse-de Recht, Saskia, Broers, Ymke, van Tol, Lenneke, Beishuizen, Edith, Boersma, Edith, van der Kraan-Donker, Annemarie, Mairuhu, Albert T A, Arnhem, Sabine van, Dees, Ad, Heller, Roxane, Hoogendorp, Merel, van de Laar, Roel J J M, Leunis-de Ruiter, Corry, Scherpenisse-Klopstra, Patricia, Warink, Kim, van den Akker-van Marle, M Elske, Akker, Lizanne E van den, Camilleri, Eleonora C, Kok, Ruben Y, Kunnekes, Inger N, Cessie, Saskia le, Nagtegaal, Hinke C, Oztürk, Hülya, van der Ploeg, Alexia M, Rein, Nienke van, Schmidt, Vibeke, Smeets, Mark J R, Dam, Marco, Velde, Hanneke van der, Abbink, Evertine, Middeldorp, Saskia, Bresser, Carlinda, Faber, Laura M, Sissing, Simone, Bhoelan, Soerajja, Elling, Tessa, Lenssen, Mark, Makelburg, Anja B U, Thedinga, Karen H, Voskuilen, Marja A J, Yspeerd, Femke, Brookman, Sandra, Lamberts, Titia, Paas, Inge, Heikens, Janneke Swart, van den Brink, Janneke, Jong, Wouter K de, van de Vendel, Aline, Wermer, Marieke J.H., van Etten, Ellis S.
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Sprache:eng
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Zusammenfassung:IntroductionPatients 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 analysisThe 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 disseminationThe 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 numberNCT06087952.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-078676