Non-variceal upper gastrointestinal bleeding (NVUGIB) is a major cause of morbidity and mortality worldwide. Incidence of NVUGIB in the US is 53 events per 100,000 adults, with approximately 160,000 hospital admissions annually. US treatment and prevention of NVUGIB continues to be a major medical emergency, costing 550-900 million dollars every year. Failure in standard of care for NVUGIB results in mortality rates from 3-4% in the US. An improved hemostatic approach to NVUGIB will significantly reduce hemorrhage related morbidity and mortality with substantial follow-on benefits to patient comfort and reduced cost in hospital care. An ideal device would be nontoxic, provide immediate hemostasis, would not require significant follow-up or removal, and allow low accuracy/acuity placement. This proposal addresses the development of such a device. To address serious NVUGIB, HemCon proposes to develop a chitosan gastrointestinal hemostatic dressing (CGHD) suitable for use in the unique environment of the gastro-intestinal (GI) tract with rapid delivery by endoscopy. The primary objective of this research proposal is to demonstrate feasibility of development of a novel efficacious CGHD and its management of challenging acute GI bleeding in a low pH fluid (i.e. the gastric environment) that can be left in place to be digested or dissolved in less than 168 hours. A secondary objective is to develop the CGHD so that it is compatible with a diagnostic endoscope via an anticipated umbrella catheter delivery system. The central hypothesis of this proposal is that the CGHD will provide effective immediate and sustained hemostasis for brisk non-variceal upper GI bleeding.
The chitosan gastrointestinal hemostatic dressing (CGHD) development will provide for rapid control (d 1 hour) of robust gastrointestinal bleeding under hospital care enabling significant reduction in morbidity and mortality (currently 3-4%) associated with non- variceal upper gastrointestinal bleeding (NVUGIB). The CGHD development has the potential to significantly reduce the overall length and cost of hospitalization associated with NVUGIB by hundreds of millions of dollars.