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Multi-site study of vascular trauma using the PROOVIT (PROspective Observational Vascular Injury Treatment) registry

Todd Costantini, MD & Joseph DuBose, MD

Investigators will review the medical records of patients in this database who suffered life- or limb-threatening vascular trauma requiring surgical repair. They’ll evaluate outcomes related to vascular graft patency at least six-months after reconstruction, demonstrating the utility of PROOVIT as a “real-world” data source to compare two approaches to traumatic vascular injury repair—arterial reconstruction with autologous vein and Humacyte’s Human Acellular Vessel (HAV).

“Vascular injuries are a significant contributor to loss of life and limb following acute trauma in both military and civilian scenarios, and amputation rates following traumatic injury are reported to be as high as eight percent,” explained Dr. Todd Costantini, MD, the primary investigator on the project. “So, there’s an urgent need for novel vascular repair options to achieve improved clinical outcomes and enhance quality of life for patients.”

While the current standard of care for vascular injuries requiring open repair is the use of autologous vein grafts, several scenarios can preclude this intervention, including concomitant injury to the vein, insufficiency of vein present, or absence of vein due to previous medical procedures. In instances when vein is available, the process of harvesting can demand increased time and resources and can negatively influence clinical outcomes. As such, the optimal vascular conduit would provide clinical outcomes similar to autologous vein, without requiring vein harvest.

Dr. Joseph Dubose, co-PI on the project, said, “The HAV has been shown to integrate with host physiology and exhibit resistance to infection compared to synthetic alternatives, and it is currently being investigated in a Phase II study for trauma. Preliminary results suggest positive patient outcomes.” Because of the promising results, the U.S. Department of Defense has supported development of the HAV, designating it a Priority Product.