Preparation And Evaluation Of A Multifunction Hemostatic Powder

Objective: Hemostasis is a key measure of trauma care and reducing transfusions ofallogeneic blood since bleeding is a common symptoms of trauma and trauma patientswith massive blood loss often require blood transfusion. Research in the field ofhemostasis has also been being a hot topic of military medicine and emergencymedicine at home and abroad. The exsited hemostatic products needs better productsubstitution in both effective and biocompatibility respects. Hence, the aim of this studyis to research and develop a multifunctional hemostatic powder with better hemostaticproperties and biocompatibility, and so on.Methods:1. Analysing of transfusion characteristics in trauma patients:1766traumacases who suffered traumatic injury and received hospital treatment between2001and2012were retrieved from the software “clinical transfusion database” which developedby our department. We retrospectively analyzed the transfusion characteristics of thepatients, then researched the effect of hemorrhagic shock and traumatic coagulopathy onthe total volume of blood transfusion, and investigated the significance of hemostasistimely and effectively to prevent allogeneic blood transfusion.2. Material screening andpreparation of styptic powder: In the study, we selected chemical hemostatic agents andstem cell factors as drug components, then carried these drugs by PS and prepared amultifunctional hemostatic powder. The adsorption of PS (porous starch) anddrug-loaded PS was evaluated by water absorption. Chemical hemostatic agents werescreened by the procoagulant tests in vitro, and the stem cell factors promoting repairwas tested by the healing of rat with full-thickness skin excision.3. Efficacy evaluatingof styptic powder: The hemostatic efficiency was evaluated by vitro and vivo test. Invitro, with the modified Lee-White method, the CT (coagulation time) was recorded.The experimental design consisted of blank control group, PS group and experimentalgroup, and10cases in each group. In vivo, we used27female SD rats to establish theanimal model of SD rats with liver trauma and then recorded the time-to-hemostasis.The rats were randomly and evenly divided into three groups: PS group, Yunnan baiyaogroup and experimental group. We evaluated the drug-release functionality and stability of the hemostatic powder through release testing and stability testing of drugrespectively.Results:1. Massive transfusion (OR=95.22), hemorrhagic shock(OR=17.2),traumatic coagulopathy (OR=4.52) were the risk factor of high volume transfusionwhich was more than10U. The transfusion rate of trauma patient was68.6%, and therewere33cases with coagulopathy.2. PS had good adsorption properties, and the waterabsorption of PS will not be affected when the drug loading capacity is not exceeding20.0mg/g PS.TA is an ideal candidate component, tranexamic acid-loaded porous starch(TAPS) with the drug loading capacity of20.0mg/g PS had the shortest CT and itswater absorption is116.4%. There was no significant difference in wound healing ratebetween SCF group and PBS group(p＞0.05).3. There was no significant statisticaldifference in CT between TAPS group and PS group(p＞0.05).Red blood cells whichgathered around the TAPS particles can be seen by microscopic observation.In ratsmodel, the time-to-hemostasis of TAPS to the left lobe of liver was236.67±55.00s,andthe haemostasis effect had the significant difference when compared with Yunnanbaiyao(340.00±73.48s,p＜0.05)or PS (396.67±68.37s,p＜0.01).TAPS could releaseTA more than50%in vitro within2minutes, and the cumulative release percentage ofTA reached93.64%after16minutes.Conclusion:1.There were approximately69%of hospitalized trauma patients requiretransfusion. Allogeneic blood transfusion can be avoided by the prevention andtreatment of haemorrhage and traumatic coagulopathy.2. TAPS with the drug loadingcapacity of20.0mg/g PS had the best homeostasis. There needs further experimentalstudy to confirm whether SCF can promote wound healing.3. TAPS has betterabsorption and stability. It promotes hemostasis by the synergistic effect of physicaladsorption and chemical hemostatic agents. The hemostasis properties of TAPS is betterthen Yunnan baiyao, and has the analogous hemostasis properties with Arista stypticpowder which developed by USA.