Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial
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...
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e078676.full |
| _version_ | 1797228860331261952 |
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| 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 Saskia le Cessie 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 Nienke van Rein 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 Wouter K de Jong Aline van de Vendel Ellis S. van Etten |
| author_facet | 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 Saskia le Cessie 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 Nienke van Rein 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 Wouter K de Jong Aline van de Vendel Ellis S. van Etten |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T15:03:24Z |
| format | Article |
| id | doaj.art-a64444f5ad18406f879dce721db0685e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-24T15:03:24Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-a64444f5ad18406f879dce721db0685e2024-04-02T14:20:09ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-078676Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial Saskia le Cessie0Nick van Es1Michiel Coppens2Karina Meijer3Suzanne C Cannegieter4Saskia Middeldorp5Menno V Huisman6Frederikus A Klok7Geert-Jan Geersing8Annette W G van der Velden9Elske M van den Akker-van Marle10Albert T A Mairuhu11M Elske van den Akker-van Marle12Laura M Faber13Saskia le Cessie14Tjerk de NijsRemy H H Bemelmans15Coen van Guldener16Marcel A van de Ree17Marieke J.H. WermerTessa Elling18Carolien van NettenMilou A M Stals19Rick Roos20J Louise I Burggraaf-van Delft21Nienke van Rein22Jan-Willem K van den Berg23Coty Y Bruggeman24Marissa Cloos-van Balen25Matthijs Eefting26Yvonne Ende-Verhaar27Wouter K de Jong28Fleur Kleijwegt29Ted Koster30Cees Kroon31Saskia Kuipers32Jenneke Leentjens33Dieuwke Luijten34Ilse Schrover35Janneke Swart-Heikens36Yavuz BilginMarleen GoddriePieter JobseSuzanne JongBrianne MurphyCarla BoekholtDanick WernerLaura KratzMarjolein KremersMonique SchildersGideon HajerBas LangeveldSaskia Teunisse-de RechtAnnemiek BogerdYmke BroersStan KolmanSanjay SankatsingLenneke van TolEdith BeishuizenShantie BharatsinghEdith BoersmaAnnemarie van der Kraan-DonkerSabine van ArnhemFransien Croon-de BoerAd DeesJ P (Hanneke) van EmbdenRoxane HellerMerel HoogendorpRoel JonkhoffRoel J J M van de LaarCorry Leunis-de RuiterPatricia Scherpenisse-KlopstraTom L H StellemaKim WarinkLizanne E van den AkkerEleonora C CamilleriTess R C HuibregtseIngeborg de JongeRuben Y KokInger N KunnekesLejla MahicHinke C NagtegaalPetra J NoordijkHülya OztürkAlexia M van der PloegNienke van ReinVibeke SchmidtAnne-Marie SchuitemakerVera C SlootwegMark J R SmeetsMilou ThibaudierMarco DamSwopkje de JongHanneke van der VeldeEvertine AbbinkCarlinda BresserSimone SissingSoerajja BhoelanÈmese HeijkoopFrancien HuismanMark LenssenAnja B U MakelburgKaren H ThedingaMarja A J VoskuilenFemke YspeerdSandra BrookmanTitia LambertsInge PaasJanneke Swart HeikensJanneke van den BrinkWouter K de JongAline van de VendelEllis S. van Etten2 Department of Epidemiology and Statistics, Leiden University Medical Centre, Leiden, The Netherlands3 Department of Vascular Medicine, Academic Medical Center, Amsterdam, The NetherlandsVascular Medicine, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands6 Faculty of Medical Sciences, University Medical Centre Groningen, Groningen, NetherlandsDepartment of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The NetherlandsVascular Medicine, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsThrombosis and Hemostasis, LUMC, Leiden, The Netherlands23 Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlandsgeneral practitioner and associate professorDepartment of Internal Medicine, Martini Hospital, Groningen, The NetherlandsDepartment of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Center, Leiden, The NetherlandsInternal Medicine, Haga Hospital, Den Haag, The NetherlandsBiomedical Data Sciences, Leiden University Medical Center, Leiden, The NetherlandsInternal Medicine, Red Cross Hospital, Beverwijk, The NetherlandsDepartment of Medical Statistics and Bioinformatics, Leiden University Medical Centre, Leiden, The NetherlandsDepartment of Vascular Medicine, University Medical Center Utrecht, Utrecht, The NetherlandsDepartment of Internal Medicine, Amphia Ziekenhuis, Breda, Noord Brabant, The Netherlandsmedical doctor specialised in internal and vascular medicinedoctoral studentThrombosis and Hemostasis, LUMC, Leiden, The NetherlandsDepartment of Internal Medicine, Haga Teaching Hospital, The Hague, The NetherlandsDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, Zuid-Holland, The NetherlandsDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, Zuid-Holland, The NetherlandsDepartment of Pulmonology, Isala Klinieken, Zwolle, Overijssel, The NetherlandsDepartment of Internal Medicine, Martini Ziekenhuis, Groningen, Groningen, The NetherlandsDepartment of Internal Medicine, Groene Hart Ziekenhuis, Gouda, Zuid-Holland, The NetherlandsDepartment of Internal Medicine, Ikazia Ziekenhuis, Rotterdam, Zuid-Holland, The NetherlandsDepartment of Internal Medicine, Medisch Centrum Haaglanden, Den Haag, Zuid-Holland, The NetherlandsDepartment of Pulmonology, Ziekenhuis Gelderse Vallei, Ede, Gelderland, The NetherlandsDepartment of Internal Medicine, Rode Kruis Ziekenhuis, Beverwijk, Noord-Holland, The NetherlandsDepartment of Internal Medicine, Groene Hart Ziekenhuis, Gouda, Zuid-Holland, The NetherlandsDepartment of Internal Medicine, Ziekenhuis Nij Smellinghe, Drachten, Friesland, The NetherlandsDepartment of Internal Medicine, ADRZ, Goes, Zeeland, The NetherlandsDepartment of Internal Medicine, Radboud university medical center, Nijmegen, Gelderland, The NetherlandsDepartment of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Zuid-Holland, The NetherlandsDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, Zuid-Holland, The NetherlandsDepartment of Clinical Epidemiology, Leiden University Medical Center, Leiden, Zuid-Holland, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/14/3/e078676.full |
| spellingShingle | 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 Saskia le Cessie 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 Nienke van Rein 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 Wouter K de Jong Aline van de Vendel Ellis S. van Etten Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial BMJ Open |
| title | Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
| title_full | Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
| title_fullStr | Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
| title_full_unstemmed | Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
| title_short | Tailored anticoagulant treatment after a first venous thromboembolism: protocol of the Leiden Thrombosis Recurrence Risk Prevention (L-TRRiP) study - cohort-based randomised controlled trial |
| title_sort | tailored anticoagulant treatment after a first venous thromboembolism protocol of the leiden thrombosis recurrence risk prevention l trrip study cohort based randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/3/e078676.full |
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