There are currently two large clinical studies and two registries involving the ER-REBOA™ Catheter: 1) The AAST AORTA Registry; 2) the ABO Trauma Registry; 3) the DoD funded Emergent Truncal Hemorrhage observational study; and 4) the UK REBOA Trial. Each is briefly described below.
- The AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery registry was initiated in 2013 and prospectively identifies and collects data for trauma patients requiring AO from several ACS Level 1 centers in the United States. Presentation, intervention, and outcome variables are being collected and analyzed to compare REBOA and open AO. There are now significant numbers of ER-REBOA™ patients enrolled in this registry. An interim report was published in the Journal of Trauma and Acute Care Surgery in 2016 and a final report is expected in 2018.
- The multicenter ABO trauma registry was established in September 2014 when REBOA practicing centers in 6 countries (Sweden, Italy, Finland, Russia, Israel, and Japan) were invited to join. The registry includes both retrospective and prospective REBOA cases. Demographics, injury patterns, hemodynamic variables, REBOA-specific data, complications and 30-days mortality are being reported and analyzed. An interim report was published in the European Journal of Trauma and Emergency Medicine Surgery in August 2017 and future reports are planned by the authors.
- The DoD funded Emergent Truncal Hemorrhage Observational Study was initiated in June 2017 and includes six Level 1 Trauma Centers in the US. The study will collect detailed prospective information on current use of the Prytime ER-REBOA™ Catheter and other emergent truncal hemorrhage control interventions (open thoracotomy, IR, or laparotomy), outcomes and complications after treatment of non-compressible truncal hemorrhage arising below the diaphragm in up to 500 patients.
- The UK REBOA Trial is a prospective, randomized, controlled clinical trial of 120 adult patients age 16 or older with confirmed or suspected life-threatening torso hemorrhage, which is thought to be amenable to adjunctive treatment with REBOA, who present to a major UK trauma centre. The study compares standard major trauma centre treatment plus REBOA, compared with standard major trauma centre treatment alone. The primary clinical outcome will be 90-day mortality (defined as death within 90 days of injury, before or after discharge from hospital). The primary economic outcome will be lifetime incremental cost per quality adjusted life year gained, from a health and personal social services perspective.