Expandable Hemostats for Treatment of Noncompressible Intracavitary Hemorrhage
Abstract
FY20 PRMRP Area of Encouragement: Hemorrhage Control (Development of new and innovative capabilities to stop non-compressible intracavitary hemorrhage). Background and Rationale: Hemorrhage, in particular non-compressible intracavitary hemorrhage from the junctional and pelvic regions, remains the leading cause of 90% preventable death on the battlefield. This is attributed to a lack of armor protection in the limbs and perineum area, which results in junctional trauma (perineal wounds and pelvic fractures). Furthermore, bullet shrapnel penetration into the body cavity restricts the ability to apply compression to the wound. Hence, it is necessary to design hemostats that prevent blood loss without applying compression to the wound site. Similarly, in the civilian population, 26%-40% of death of trauma patients is attributed to non-compressible intracavitary hemorrhage, including anastomosis hemorrhage and percutaneous intervention during surgery. So, early (e.g., pre-hospital) hemorrhage control allowing for bridging to definitive surgical care, may yield a large survival advantage. Life-threatening hemorrhage is a time-dependent disease in which the duration of ongoing bleeding may either lead to death or, in case of initial survival and subsequent massive transfusion, to possible sepsis and multi-organ failure. Hence, it is necessary to design hemostats that prevent blood loss without applying compression to the wound site. Among currently available hemostats, QuikClot™ and Celox™, have been extensively used in military applications. QuikClot™ is a first-generation zeolite-based hemostatic gauze containing kaolin, a naturally occurring clay that activates the intrinsic pathway of the clotting cascade. On the other hand, Celox™ is a second-generation chitosan-based granular hemostat that helps plug blood flow by creating a sealant using red blood cells (RBCs) and platelets. Importantly, the kaolin that is found in QuikClot™ is an inorganic non-bioresorbable clay, which needs to be removed during surgery, thus increasing the chances of surgery complications. Additionally, the time and performance of Celox™ is independent of the physiological components, but become flakey to use, which limit its application for internal wounds. A promising new hemostat, XStat™ has an improved time to hemostasis, but survival rates require the insertion of ~92 miniature sponges, which need to be removed from the patient within 4 hours, limiting its applicability in prolonged field care and non-compressible intracavitary hemorrhage. Overall, currently available commercial hemostats lack multiple characteristics needed for non-compressible intracavitary hemorrhage including (a) quick hemostatic ability, (b) injectable and expandable hemostats for non-compressible wounds, (c) deployable in the battlefield, and (d) bioresorbable. To address these challenges, we propose an integrated, multidisciplinary strategy that leverages our expertise in responsive biomaterials (Principal Investigator PI: Gaharwar), as well as shape memory devices (co-Investigator: Maitland), to design the next generation of hemostats for treatment of non-compressible intracavitary hemorrhage. Objective, Hypothesis and Specific Aims: The primary objective of this proposal is to develop and validate shape-memory hemostat to facilitate rapid hemostasis in non-compressible intracavitary hemorrhages. We hypothesize that intracavitary administration of a shape-memory hemostat with a high expansion ratio would result in rapid hemostasis (<2 minutes) and improved survival of patients with lethal battlefield injuries. The proposed hemostat will consist of two major components: first, a biodegradable shear-thinning biomaterial loaded with 2D nanosilicates to achieve rapid hemostasis and second, a biodegradable shape-memory polymer microfoam for rapid expansion in the wound cavity. This project builds upon the PI’s (Gaharwar) patented nanosilicates-based injectable hem
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210932
Entities
People
- Akhilesh K. Gaharwar
Organizations
- Texas Engineering Experiment Station
- United States Army