Clinical studies and registries involving the ER-REBOA™ Catheter

AAST AORTA Registry

The AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery registry was initiated in 2013. The study 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 significant numbers of ER-REBOA™ Catheter 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.

ABO Trauma Registry 

The multicenter ABO trauma registry was established in September 2014 when REBOA practicing centers in six 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 with  future reports planned by the authors.

DoD funded Emergent Truncal Hemorrhage Observational Study

The Department of Defense (DoD) funded Emergent Truncal Hemorrhage Observational Study was initiated in June 2017. The study, based in the United States, included six Level 1 Trauma Centers. Enrollment of new patients ended on June 15, 2018 with over 450 patients included in the study. The study is the first prospective observational investigation designed to collect detailed information on the ER-REBOA™ Catheter and other emergent truncal hemorrhage control interventions (open thoracotomy, IR, laparotomy). The study also collected information on outcomes and complications after treatment of non-compressible truncal hemorrhage arising below the diaphragm. Analysis of study data is ongoing.

UK REBOA Trial

The UK REBOA Trial is a prospective, randomized, controlled clinical trial of 120 adult patients age 16 or older. Patients include those 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 center. The study compares standard major trauma center treatment plus REBOA, compared with standard major trauma center 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.