TY - JOUR
T1 - Tailored anticoagulant treatment after a first venous thromboembolism
T2 - protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial
AU - Burggraaf-van Delft, J. Louise I.
AU - van Rein, Nienke
AU - Bemelmans, Remy H. H.
AU - van den Berg, Jan-Willem K.
AU - Bruggeman, Coty Y.
AU - Cloos-van Balen, Marissa
AU - Coppens, Michiel
AU - Eefting, Matthijs
AU - Ende-Verhaar, Yvonne
AU - van Es, Nick
AU - van Guldener, Coen
AU - de Jong, Wouter K.
AU - Kleijwegt, Fleur
AU - Koster, Ted
AU - Kroon, Cees
AU - Kuipers, Saskia
AU - Leentjens, Jenneke
AU - Luijten, Dieuwke
AU - Mairuhu, Albert T. A.
AU - Meijer, Karina
AU - van de Ree, Marcel A.
AU - Roos, Rick
AU - Schrover, Ilse
AU - Swart-Heikens, Janneke
AU - van der Velden, Annette W. G.
AU - van den Akker-van Marle, Elske M.
AU - L-TRRiP investigators
AU - le Cessie, Saskia
AU - Geersing, Geert-Jan
AU - Middeldorp, Saskia
AU - Huisman, Menno V.
AU - Klok, Frederikus A.
AU - Cannegieter, Suzanne C.
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/3/23
Y1 - 2024/3/23
N2 - 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.
AB - 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.
KW - Anticoagulation
KW - Clinical trials
KW - EPIDEMIOLOGIC STUDIES
KW - Thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85188868219&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-078676
DO - 10.1136/bmjopen-2023-078676
M3 - Article
C2 - 38521524
SN - 2044-6055
VL - 14
SP - e078676
JO - BMJ Open
JF - BMJ Open
IS - 3
ER -