Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study)
Introduction Pharmacomechanical thrombectomy (PMT) can be a useful treatment for restoring vein patency quickly, especially for extensive acute deep vein thrombosis (DVT). However, previous evidence failed to validate the effectiveness of PMT in reducing the incidence of post-thrombotic syndrome (PT...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/6/e089797.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850125747685949440 |
|---|---|
| author | Hui Zhao Hui Zhuang Meng Ye Hongfei Sang Ziheng Wu Qihong Ni Xiande Ye Chunshui He Wensheng Lou |
| author_facet | Hui Zhao Hui Zhuang Meng Ye Hongfei Sang Ziheng Wu Qihong Ni Xiande Ye Chunshui He Wensheng Lou |
| author_sort | Hui Zhao |
| collection | DOAJ |
| description | Introduction Pharmacomechanical thrombectomy (PMT) can be a useful treatment for restoring vein patency quickly, especially for extensive acute deep vein thrombosis (DVT). However, previous evidence failed to validate the effectiveness of PMT in reducing the incidence of post-thrombotic syndrome (PTS). To address this controversy, the reformation study aims to improve rheolytic thrombectomy for acute DVT of the lower limb through primary popliteal vein thrombosis clearance.Method and analysis Reformation is a prospective randomised multicentre trial. It has 160 patients in two groups: the modified access group (80 patients) and the traditional access group (80 patients). The purpose of this study is to assess whether the modified access approach for removing inflow thrombus in a one-stage procedure is more effective in enhancing the success rate of the procedure and reducing the incidence of PTS during a 24-month follow-up period, for patients with acute whole limb DVT.Ethics and dissemination The reformation study has been registered at www.clinicaltrials.gov. The study protocol has been approved by the Institutional Review Board and Human Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (approved number: KY2021-067-A). The results will be disseminated by publication in a peer-reviewed journal.Trial registration number NCT05286710.Protocol version and date V.1.2, 20 August 2022. |
| format | Article |
| id | doaj-art-4d39bff59be342c2b755a07a42fe3372 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4d39bff59be342c2b755a07a42fe33722025-08-20T02:34:04ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-089797Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study)Hui Zhao0Hui Zhuang1Meng Ye2Hongfei Sang3Ziheng Wu4Qihong Ni5Xiande Ye6Chunshui He7Wensheng Lou8Nantong University Affiliated Hospital, Nantong, ChinaDepartment of Vascular Surgery, Xiamen University Xiamen Cardiovascular Hospital, Xiamen, ChinaDepartment of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, ChinaSecond Affiliated Hospital of Soochow University, Suzhou, Jiangsu, ChinaDepartment of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, ChinaDepartment of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, ChinaDepartment of General Surgery, Shanghai Pudong New Area People’s Hospital, Shanghai, ChinaDepartment of Vascular Surgery, Chengdu University of Traditional Chinese Medicine, Chengdu, ChinaInterventional Vascular Department, The Affiliated Hospital of Nanjing University Medical School, Nanjing, ChinaIntroduction Pharmacomechanical thrombectomy (PMT) can be a useful treatment for restoring vein patency quickly, especially for extensive acute deep vein thrombosis (DVT). However, previous evidence failed to validate the effectiveness of PMT in reducing the incidence of post-thrombotic syndrome (PTS). To address this controversy, the reformation study aims to improve rheolytic thrombectomy for acute DVT of the lower limb through primary popliteal vein thrombosis clearance.Method and analysis Reformation is a prospective randomised multicentre trial. It has 160 patients in two groups: the modified access group (80 patients) and the traditional access group (80 patients). The purpose of this study is to assess whether the modified access approach for removing inflow thrombus in a one-stage procedure is more effective in enhancing the success rate of the procedure and reducing the incidence of PTS during a 24-month follow-up period, for patients with acute whole limb DVT.Ethics and dissemination The reformation study has been registered at www.clinicaltrials.gov. The study protocol has been approved by the Institutional Review Board and Human Research Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiao Tong University (approved number: KY2021-067-A). The results will be disseminated by publication in a peer-reviewed journal.Trial registration number NCT05286710.Protocol version and date V.1.2, 20 August 2022.https://bmjopen.bmj.com/content/15/6/e089797.full |
| spellingShingle | Hui Zhao Hui Zhuang Meng Ye Hongfei Sang Ziheng Wu Qihong Ni Xiande Ye Chunshui He Wensheng Lou Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) BMJ Open |
| title | Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) |
| title_full | Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) |
| title_fullStr | Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) |
| title_full_unstemmed | Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) |
| title_short | Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study) |
| title_sort | improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance protocol for a prospective multicenter randomized controlled trial the reformation study |
| url | https://bmjopen.bmj.com/content/15/6/e089797.full |
| work_keys_str_mv | AT huizhao improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT huizhuang improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT mengye improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT hongfeisang improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT zihengwu improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT qihongni improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT xiandeye improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT chunshuihe improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy AT wenshenglou improvementofrheolyticthrombectomyforacutedeepveinthrombosisofthewholelowerlimbbyprimarypoplitealveinthrombosisclearanceprotocolforaprospectivemulticenterrandomizedcontrolledtrialthereformationstudy |