TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol
Introduction The post-thrombotic syndrome (PTS) is a form of chronic venous insufficiency due to a prior ipsilateral deep venous thrombosis (DVT). This is a frequent complication that develops in 20%–50% of patients after a proximal DVT and is associated with significant healthcare, economic and soc...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/10/e064715.full |
| _version_ | 1797628999940177920 |
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| author | Sam Schulman Aurélien Delluc Jameel Abdulrehman Susan Kahn Jean-Philippe Galanaud Ilia Makedonov Peter L Gross |
| author_facet | Sam Schulman Aurélien Delluc Jameel Abdulrehman Susan Kahn Jean-Philippe Galanaud Ilia Makedonov Peter L Gross |
| author_sort | Sam Schulman |
| collection | DOAJ |
| description | Introduction The post-thrombotic syndrome (PTS) is a form of chronic venous insufficiency due to a prior ipsilateral deep venous thrombosis (DVT). This is a frequent complication that develops in 20%–50% of patients after a proximal DVT and is associated with significant healthcare, economic and societal consequences. In the absence of effective and well-tolerated treatment options for established PTS, effective preventative measures are needed. Anticoagulation itself reduces the risk of PTS, and low-molecular-weight heparin may reduce this further through anti-inflammatory properties targeting the initial acute inflammatory phase of DVT.Methods and analysis The Tinzaparin Lead-In to Prevent the Post-Thrombotic syndrome pilot trial is an investigator-initiated, multicentre, open-label assessor-blinded trial that will randomise patients with first acute symptomatic common femoral or iliac DVT to receive either a 3-week lead-in course of tinzaparin, followed by rivaroxaban (experimental arm) or rivaroxaban alone (control arm). Its primary objectives are to assess: (1) proportion of PTS at 6 months using the Villalta scale and (2) study feasibility, which consists of (a) the proportion of screened patients eligible for the study, (2) the proportion of eligible patients recruited and (c) the proportion of recruited patients adherent to treatment (defined as at least 80% of drug taken). This study will determine the feasibility of a subsequent larger definitive trial. Secondary outcomes include change of quality of life scores, PTS severity, global improvement, patient satisfaction, bleeding, recurrent venous thromboembolism, leg pain, death and lost to follow-up. Target recruitment will be a total of 60 participants, recruited at 5–6 centres.Ethics and dissemination Primary ethics approval was received from the Sunnybrook Health Sciences Center Research Ethics Board (approval ID 3315). Results of the study will be disseminated via peer-reviewed presentation at scientific conferences and open access publication.Trial registration number NCT04794569. |
| first_indexed | 2024-03-11T10:48:10Z |
| format | Article |
| id | doaj.art-8ac82595b200489eb6d2c435395a7049 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T10:48:10Z |
| publishDate | 2023-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-8ac82595b200489eb6d2c435395a70492023-11-13T23:50:08ZengBMJ Publishing GroupBMJ Open2044-60552023-10-01131010.1136/bmjopen-2022-064715TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocolSam Schulman0Aurélien Delluc1Jameel Abdulrehman2Susan Kahn3Jean-Philippe Galanaud4Ilia Makedonov5Peter L Gross6professor6 Department of Medicine, University of Ottawa, Ottawa, Ontario, CanadaMedicine, University Health Network, Toronto, Ontario, CanadaMedicine, McGill University, Montreal, Quebec, CanadaDepartment of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada1 Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada5 Department of Medicine, McMaster University, Hamilton, Ontario, CanadaIntroduction The post-thrombotic syndrome (PTS) is a form of chronic venous insufficiency due to a prior ipsilateral deep venous thrombosis (DVT). This is a frequent complication that develops in 20%–50% of patients after a proximal DVT and is associated with significant healthcare, economic and societal consequences. In the absence of effective and well-tolerated treatment options for established PTS, effective preventative measures are needed. Anticoagulation itself reduces the risk of PTS, and low-molecular-weight heparin may reduce this further through anti-inflammatory properties targeting the initial acute inflammatory phase of DVT.Methods and analysis The Tinzaparin Lead-In to Prevent the Post-Thrombotic syndrome pilot trial is an investigator-initiated, multicentre, open-label assessor-blinded trial that will randomise patients with first acute symptomatic common femoral or iliac DVT to receive either a 3-week lead-in course of tinzaparin, followed by rivaroxaban (experimental arm) or rivaroxaban alone (control arm). Its primary objectives are to assess: (1) proportion of PTS at 6 months using the Villalta scale and (2) study feasibility, which consists of (a) the proportion of screened patients eligible for the study, (2) the proportion of eligible patients recruited and (c) the proportion of recruited patients adherent to treatment (defined as at least 80% of drug taken). This study will determine the feasibility of a subsequent larger definitive trial. Secondary outcomes include change of quality of life scores, PTS severity, global improvement, patient satisfaction, bleeding, recurrent venous thromboembolism, leg pain, death and lost to follow-up. Target recruitment will be a total of 60 participants, recruited at 5–6 centres.Ethics and dissemination Primary ethics approval was received from the Sunnybrook Health Sciences Center Research Ethics Board (approval ID 3315). Results of the study will be disseminated via peer-reviewed presentation at scientific conferences and open access publication.Trial registration number NCT04794569.https://bmjopen.bmj.com/content/13/10/e064715.full |
| spellingShingle | Sam Schulman Aurélien Delluc Jameel Abdulrehman Susan Kahn Jean-Philippe Galanaud Ilia Makedonov Peter L Gross TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol BMJ Open |
| title | TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol |
| title_full | TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol |
| title_fullStr | TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol |
| title_full_unstemmed | TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol |
| title_short | TILE pilot trial study protocol: Tinzaparin Lead-in to Prevent the Post-Thrombotic syndrome study protocol |
| title_sort | tile pilot trial study protocol tinzaparin lead in to prevent the post thrombotic syndrome study protocol |
| url | https://bmjopen.bmj.com/content/13/10/e064715.full |
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