Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Burggraaf-van Delft J Louise I, van Rein Nienke, 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, de Jong Wouter K, Kleijwegt Fleur, Koster Ted, Kroon Cees, Kuipers Saskia, Leentjens Jenneke, Luijten Dieuwke, Mairuhu Albert T A, Meijer Karina, van de Ree Marcel A, Roos Rick, Schrover Ilse, Swart-Heikens Janneke, van der Velden Annette W G, van den Akker-van Marle Elske M, le Cessie Saskia, Geersing Geert-Jan, Middeldorp Saskia, Huisman Menno V, Klok Frederikus A, Cannegieter Suzanne C, L-TRRiP investigators
Аннотация
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.