Intrauterine application of a kaolin-based hemostatic agent for PPH

Organization: 
Z-Medica Corporation
Organization Location: 
Wallingford, CT USA

In developing countries Post Partum Hemorrhage (PPH) is the single most common cause of maternal morbidity and mortality and accounts for approximately 25 percent of maternal deaths globally. We propose to use an existing technology called QuikClot as a safe, effective, simple to use and low cost form of treatment for PPH. QuikClot is a hemostatic gauze containing kaolin, an inert mineral that promotes blood clotting; currently QuikClot is the main hemostatic device used by all branches of the US Military to control bleeding following war injuries. QuikClot is FDA cleared for the treatment of severe bleeding and has been judged simple enough to be used by unskilled individuals such as every single soldier, marine, sailor and airman within the US Military. QuikClot products are currently used also by health care providers in hospitals in the US and abroad. We propose to develop a novel hemostatic agent specifically designed for the treatment of PPH and based on the current, well validated kaolin-based hemostatic gauze. We plan to reach this goal with the help of experts in the field. We also propose to use the Seed Grant funds for the design and implementation of a feasibility pilot trial of treatment of PPH in a health care facility in a low resource setting. We anticipate that QuikClot will successfully control bleeding in PPH and significantly reduce morbidity and mortality. These results will lead to larger trials in more rural and distant setting where QuikClot will be applied by local unskilled individuals.