Protocol of the Reformation study: a prospective, multicenter, randomized controlled trial on the improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance

Abstract 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 deep vein thrombosis of the lower limb through primary popliteal vein thrombosis clearance. Method and analysis: Reformation is a prospective randomized multicenter 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 post-thrombotic syndrome 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 (registration number: NCT05286710). 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