Tailored anticoagulant treatment after a first venous thromboembolism : protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial
© 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..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
BMJ open - 14(2024), 3 vom: 23. März, Seite e078676 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Burggraaf-van Delft, J Louise I [VerfasserIn] |
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| Links: |
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| Themen: |
Anticoagulants |
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| Anmerkungen: |
Date Completed 25.03.2024 Date Revised 28.03.2024 published: Electronic ClinicalTrials.gov: NCT06087952 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2023-078676 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Tailored anticoagulant treatment after a first venous thromboembolism |b protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
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| 500 | |a Date Revised 28.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT06087952 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 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. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT06087952 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Anticoagulation | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a EPIDEMIOLOGIC STUDIES | |
| 650 | 4 | |a Thromboembolism | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 700 | 1 | |a van Rein, Nienke |e verfasserin |4 aut | |
| 700 | 1 | |a Bemelmans, Remy H H |e verfasserin |4 aut | |
| 700 | 1 | |a van den Berg, Jan-Willem K |e verfasserin |4 aut | |
| 700 | 1 | |a Bruggeman, Coty Y |e verfasserin |4 aut | |
| 700 | 1 | |a Cloos-van Balen, Marissa |e verfasserin |4 aut | |
| 700 | 1 | |a Coppens, Michiel |e verfasserin |4 aut | |
| 700 | 1 | |a Eefting, Matthijs |e verfasserin |4 aut | |
| 700 | 1 | |a Ende-Verhaar, Yvonne |e verfasserin |4 aut | |
| 700 | 1 | |a van Es, Nick |e verfasserin |4 aut | |
| 700 | 1 | |a van Guldener, Coen |e verfasserin |4 aut | |
| 700 | 1 | |a de Jong, Wouter K |e verfasserin |4 aut | |
| 700 | 1 | |a Kleijwegt, Fleur |e verfasserin |4 aut | |
| 700 | 1 | |a Koster, Ted |e verfasserin |4 aut | |
| 700 | 1 | |a Kroon, Cees |e verfasserin |4 aut | |
| 700 | 1 | |a Kuipers, Saskia |e verfasserin |4 aut | |
| 700 | 1 | |a Leentjens, Jenneke |e verfasserin |4 aut | |
| 700 | 1 | |a Luijten, Dieuwke |e verfasserin |4 aut | |
| 700 | 1 | |a Mairuhu, Albert T A |e verfasserin |4 aut | |
| 700 | 1 | |a Meijer, Karina |e verfasserin |4 aut | |
| 700 | 1 | |a van de Ree, Marcel A |e verfasserin |4 aut | |
| 700 | 1 | |a Roos, Rick |e verfasserin |4 aut | |
| 700 | 1 | |a Schrover, Ilse |e verfasserin |4 aut | |
| 700 | 1 | |a Swart-Heikens, Janneke |e verfasserin |4 aut | |
| 700 | 1 | |a van der Velden, Annette W G |e verfasserin |4 aut | |
| 700 | 1 | |a van den Akker-van Marle, Elske M |e verfasserin |4 aut | |
| 700 | 1 | |a le Cessie, Saskia |e verfasserin |4 aut | |
| 700 | 1 | |a Geersing, Geert-Jan |e verfasserin |4 aut | |
| 700 | 1 | |a Middeldorp, Saskia |e verfasserin |4 aut | |
| 700 | 1 | |a Huisman, Menno V |e verfasserin |4 aut | |
| 700 | 1 | |a Klok, Frederikus A |e verfasserin |4 aut | |
| 700 | 1 | |a Cannegieter, Suzanne C |e verfasserin |4 aut | |
| 700 | 0 | |a L-TRRiP investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Bilgin, Yavuz |e investigator |4 oth | |
| 700 | 1 | |a Goddrie, Marleen |e investigator |4 oth | |
| 700 | 1 | |a Jobse, Pieter |e investigator |4 oth | |
| 700 | 1 | |a Jong, Suzanne |e investigator |4 oth | |
| 700 | 1 | |a Kuipers, Saskia |e investigator |4 oth | |
| 700 | 1 | |a Murphy, Brianne |e investigator |4 oth | |
| 700 | 1 | |a Netten, Carolien van |e investigator |4 oth | |
| 700 | 1 | |a Boekholt, Carla |e investigator |4 oth | |
| 700 | 1 | |a van Guldener, Coen |e investigator |4 oth | |
| 700 | 1 | |a Werner, Danick |e investigator |4 oth | |
| 700 | 1 | |a Coppens, Michiel |e investigator |4 oth | |
| 700 | 1 | |a van Es, Nick |e investigator |4 oth | |
| 700 | 1 | |a Kratz, Laura |e investigator |4 oth | |
| 700 | 1 | |a Kremers, Marjolein |e investigator |4 oth | |
| 700 | 1 | |a Schilders, Monique |e investigator |4 oth | |
| 700 | 1 | |a Hajer, Gideon |e investigator |4 oth | |
| 700 | 1 | |a Langeveld, Bas |e investigator |4 oth | |
| 700 | 1 | |a Teunisse-de Recht, Saskia |e investigator |4 oth | |
| 700 | 1 | |a Bogerd, Annemiek |e investigator |4 oth | |
| 700 | 1 | |a Broers, Ymke |e investigator |4 oth | |
| 700 | 1 | |a Kolman, Stan |e investigator |4 oth | |
| 700 | 1 | |a van de Ree, Marcel A |e investigator |4 oth | |
| 700 | 1 | |a Sankatsing, Sanjay |e investigator |4 oth | |
| 700 | 1 | |a Cloos-van Balen, Marissa |e investigator |4 oth | |
| 700 | 1 | |a Koster, Ted |e investigator |4 oth | |
| 700 | 1 | |a van Tol, Lenneke |e investigator |4 oth | |
| 700 | 1 | |a Beishuizen, Edith |e investigator |4 oth | |
| 700 | 1 | |a Ende-Verhaar, Yvonne |e investigator |4 oth | |
| 700 | 1 | |a Stals, Milou A M |e investigator |4 oth | |
| 700 | 1 | |a Bharatsingh, Shantie |e investigator |4 oth | |
| 700 | 1 | |a Boersma, Edith |e investigator |4 oth | |
| 700 | 1 | |a van der Kraan-Donker, Annemarie |e investigator |4 oth | |
| 700 | 1 | |a Mairuhu, Albert T A |e investigator |4 oth | |
| 700 | 1 | |a Roos, Rick |e investigator |4 oth | |
| 700 | 1 | |a Arnhem, Sabine van |e investigator |4 oth | |
| 700 | 1 | |a Croon-de Boer, Fransien |e investigator |4 oth | |
| 700 | 1 | |a Dees, Ad |e investigator |4 oth | |
| 700 | 1 | |a Eefting, Matthijs |e investigator |4 oth | |
| 700 | 1 | |a van Embden, J P Hanneke |e investigator |4 oth | |
| 700 | 1 | |a Heller, Roxane |e investigator |4 oth | |
| 700 | 1 | |a Hoogendorp, Merel |e investigator |4 oth | |
| 700 | 1 | |a Jonkhoff, Roel |e investigator |4 oth | |
| 700 | 1 | |a van de Laar, Roel J J M |e investigator |4 oth | |
| 700 | 1 | |a Leunis-de Ruiter, Corry |e investigator |4 oth | |
| 700 | 1 | |a Scherpenisse-Klopstra, Patricia |e investigator |4 oth | |
| 700 | 1 | |a van den Berg, Jan-Willem K |e investigator |4 oth | |
| 700 | 1 | |a Stellema, Tom L H |e investigator |4 oth | |
| 700 | 1 | |a Warink, Kim |e investigator |4 oth | |
| 700 | 1 | |a van den Akker-van Marle, M Elske |e investigator |4 oth | |
| 700 | 1 | |a Akker, Lizanne E van den |e investigator |4 oth | |
| 700 | 1 | |a Burggraaf-van Delft, J Louise I |e investigator |4 oth | |
| 700 | 1 | |a Camilleri, Eleonora C |e investigator |4 oth | |
| 700 | 1 | |a Cannegieter, Suzanne C |e investigator |4 oth | |
| 700 | 1 | |a Huibregtse, Tess R C |e investigator |4 oth | |
| 700 | 1 | |a Huisman, Menno V |e investigator |4 oth | |
| 700 | 1 | |a de Jonge, Ingeborg |e investigator |4 oth | |
| 700 | 1 | |a Klok, Frederikus A |e investigator |4 oth | |
| 700 | 1 | |a Kok, Ruben Y |e investigator |4 oth | |
| 700 | 1 | |a Kunnekes, Inger N |e investigator |4 oth | |
| 700 | 1 | |a Cessie, Saskia le |e investigator |4 oth | |
| 700 | 1 | |a Luijten, Dieuwke |e investigator |4 oth | |
| 700 | 1 | |a Mahic, Lejla |e investigator |4 oth | |
| 700 | 1 | |a Nagtegaal, Hinke C |e investigator |4 oth | |
| 700 | 1 | |a Noordijk, Petra J |e investigator |4 oth | |
| 700 | 1 | |a Oztürk, Hülya |e investigator |4 oth | |
| 700 | 1 | |a van der Ploeg, Alexia M |e investigator |4 oth | |
| 700 | 1 | |a Rein, Nienke van |e investigator |4 oth | |
| 700 | 1 | |a Schmidt, Vibeke |e investigator |4 oth | |
| 700 | 1 | |a Schuitemaker, Anne-Marie |e investigator |4 oth | |
| 700 | 1 | |a Slootweg, Vera C |e investigator |4 oth | |
| 700 | 1 | |a Smeets, Mark J R |e investigator |4 oth | |
| 700 | 1 | |a Thibaudier, Milou |e investigator |4 oth | |
| 700 | 1 | |a Bruggeman, Coty Y |e investigator |4 oth | |
| 700 | 1 | |a van der Velden, Annette W G |e investigator |4 oth | |
| 700 | 1 | |a Dam, Marco |e investigator |4 oth | |
| 700 | 1 | |a de Jong, Swopkje |e investigator |4 oth | |
| 700 | 1 | |a Kroon, Cees |e investigator |4 oth | |
| 700 | 1 | |a Velde, Hanneke van der |e investigator |4 oth | |
| 700 | 1 | |a Abbink, Evertine |e investigator |4 oth | |
| 700 | 1 | |a Leentjens, Jenneke |e investigator |4 oth | |
| 700 | 1 | |a Middeldorp, Saskia |e investigator |4 oth | |
| 700 | 1 | |a Bresser, Carlinda |e investigator |4 oth | |
| 700 | 1 | |a Faber, Laura M |e investigator |4 oth | |
| 700 | 1 | |a Kleijwegt, Fleur |e investigator |4 oth | |
| 700 | 1 | |a Nijs, Tjerk de |e investigator |4 oth | |
| 700 | 1 | |a Sissing, Simone |e investigator |4 oth | |
| 700 | 1 | |a Bhoelan, Soerajja |e investigator |4 oth | |
| 700 | 1 | |a Elling, Tessa |e investigator |4 oth | |
| 700 | 1 | |a Heijkoop, Èmese |e investigator |4 oth | |
| 700 | 1 | |a Huisman, Francien |e investigator |4 oth | |
| 700 | 1 | |a Lenssen, Mark |e investigator |4 oth | |
| 700 | 1 | |a Makelburg, Anja B U |e investigator |4 oth | |
| 700 | 1 | |a Meijer, Karina |e investigator |4 oth | |
| 700 | 1 | |a Thedinga, Karen H |e investigator |4 oth | |
| 700 | 1 | |a Voskuilen, Marja A J |e investigator |4 oth | |
| 700 | 1 | |a Yspeerd, Femke |e investigator |4 oth | |
| 700 | 1 | |a Brookman, Sandra |e investigator |4 oth | |
| 700 | 1 | |a Lamberts, Titia |e investigator |4 oth | |
| 700 | 1 | |a Paas, Inge |e investigator |4 oth | |
| 700 | 1 | |a Heikens, Janneke Swart |e investigator |4 oth | |
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