The world-wide impact of traumatic injury and associated hemorrhage on human health and well-being cannot be overstated. Twelve percent of the global disease burden is the result of violence or accidental injury. Hemorrhage is responsible for 30 to 40% of trauma mortality, and of these deaths, 33 to 56% occur during the prehospital period. Among those who reach care, early mortality is caused by continued hemorrhage, coagulopathy, and incomplete resuscitation. The techniques of early care, including blood transfusion, may underlie late mortality and long-term morbidity. While the volume of blood lost cannot be measured, physiologic and chemical measures and the number of units of blood given are readily recorded and analyzed. Improvements in early hemorrhage control and resuscitation and the prevention and aggressive treatment of coagulopathy appear to have the greatest potential to improve outcomes in severely injured trauma patients.

Impact of hemorrhage on trauma outcome: an overview of epidemiology, clinical presentations, and therapeutic considerations.

Bleeding complications arising from trauma, surgery, and as congenital, disease-associated, or drug-induced blood disorders can cause significant morbidities and mortalities in civilian and military populations. Therefore, stoppage of bleeding (hemostasis) is of paramount clinical significance in prophylactic, surgical, and emergency scenarios. For externally accessible injuries, a variety of natural and synthetic biomaterials have undergone robust research, leading to hemostatic technologies including glues, bandages, tamponades, tourniquets, dressings, and procoagulant powders. In contrast, treatment of internal noncompressible hemorrhage still heavily depends on transfusion of whole blood or blood's hemostatic components (platelets, fibrinogen, and coagulation factors). Transfusion of platelets poses significant challenges of limited availability, high cost, contamination risks, short shelf-life, low portability, performance variability, and immunological side effects, while use of fibrinogen or coagulation factors provides only partial mechanisms for hemostasis. With such considerations, significant interdisciplinary research endeavors have been focused on developing materials and technologies that can be manufactured conveniently, sterilized to minimize contamination and enhance shelf-life, and administered intravenously to mimic, leverage, and amplify physiological hemostatic mechanisms. Here, a comprehensive review regarding the various topical, intracavitary, and intravenous hemostatic technologies in terms of materials, mechanisms, and state-of-art is provided, and challenges and opportunities to help advancement of the field are discussed.

/pdf/biomaterials-and-advanced-technologies-for-hemostatic-7zfgldaph9.pdf

Biomaterials and Advanced Technologies for Hemostatic Management of Bleeding.

Seminal recent studies that have shed new light on the remarkable properties of clay interactions suggest unexplored opportunities for biomaterial design and regenerative medicine. Here, recent conceptual and technological developments in the science of clay interactions with biomolecules, polymers, and cells are examined, focusing on the implications for tissue engineering and regenerative strategies. Pioneering studies demonstrating the utility of clay for drug-delivery and scaffold design are reviewed and areas for future research and development highlighted.

/pdf/clay-new-opportunities-for-tissue-regeneration-and-50w2ojn60c.pdf

Clay: new opportunities for tissue regeneration and biomaterial design.

Objectives: Uncontrolled hemorrhage remains a leading cause of traumatic death. Several topical adjunct agents have been shown to be effective in controlling hemorrhage, and two, chitosan wafer dressing (HemCon [HC]) and zeolite powder dressing (QuikClot [QC]), are being utilized regularly on the battlefield. However, recent literature reviews have concluded that no ideal topical agent exists. The authors compared a new chitosan granule dressing (CELOX [CX]) to HC, QC and standard dressing in a lethal hemorrhagic groin injury.

Methods:  A complex groin injury with transection of the femoral vessels and 3 minutes of uncontrolled hemorrhage was created in 48 swine. The animals were then randomized to four treatment groups (12 animals each). Group 1 included standard gauze dressing (SD); Group 2, CX; Group 3, HC; and Group 4, QC. Each agent was applied with 5 minutes of manual pressure followed by a standard field compression dressing. Hetastarch (500 mL) was infused over 30 minutes. Hemodynamic parameters were recorded over 180 minutes. Primary endpoints included rebleed and death.

Results:  CX reduced rebleeding to 0% (p < 0.001), HC to 33% (95% CI = 19.7% to 46.3%, p = 0.038), and QC to 8% (95% CI = 3.3% to 15.7%, p = 0.001), compared to 83% (95% CI = 72.4% to 93.6%) for SD. CX improved survival to 100% compared to SD at 50% (95% CI = 35.9% to 64.2%, p = 0.018). Survival for HC (67%) (95% CI = 53.7% to 80.3%) and QC (92%; 95% CI = 84.3% to 99.7%) did not differ from SD.

Conclusions:  In this porcine model of uncontrolled hemorrhage, CX improved hemorrhage control and survival. CELOX is a viable alternative for the treatment of severe hemorrhage.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1553-2712.2007.00009.x

An Alternative Hemostatic Dressing: Comparison of CELOX, HemCon, and QuikClot

/pdf/nano-hemostat-solution-immediate-hemostasis-at-the-nanoscale-1xtf203ffo.pdf

Nano hemostat solution: Immediate hemostasis at the nanoscale

Minimally processed greige (unbleached) cotton fibers demonstrate enhanced clotting relative to highly processed United States Pharmacopeia (USP) type 7 bleached cotton gauze. This effect is thought to be due to the material surface polarity. We hypothesized that a textile could be constructed, conserving the hemostasis-accelerating properties of greige cotton, while maintaining structural integrity and improving absorbance. Spun bond nonwovens of varying surface polarity were designed and prepared based on ratios of greige cotton/bleached cotton/polypropylene fibers. A thromboelastographic analysis was performed on fibrous samples in citrated blood to evaluate the rate of fibrin and clot formation. Lee White clotting times were obtained to assess the material's clotting activity in platelet fresh blood. An electrokinetic analysis of samples was performed to analyze for material surface polarity. Hemostatic properties varied with composition ratios, fiber density, and fabric fenestration. The determinations of the surface polarity of cotton fabrics with electrokinetic analysis uncovered a range of surface polarities implicated in fabric-initiated clotting; a three-point design approach was employed with the combined use of thromboelastography, thrombin velocity index, Lee White clotting, and absorption capacity determinations applied to fabric structure versus function analysis. The resulting analysis demonstrates that greige cotton may be utilized, along with hydrophilic and hydrophobic fibers, to improve the initiation of fibrin formation and a decrease in clotting time in hemostatic dressings suitable to be commercially developed. Hydroentanglement is an efficient and effective process for imparting structural integrity to cotton-based textiles, while conserving hemostatic function.

Development of a Nonwoven Hemostatic Dressing Based on Unbleached Cotton: A De Novo Design Approach

Introduction Developing affordable and effective hemostatic and antimicrobial wound dressings for prolonged field care (PFC) of open wounds is of interest to prevent infection, to prevent sepsis, and to conserve tissue viability. The need for an effective hemostatic dressing that is also antimicrobial is required of a hemostatic dressing that can be left in place for extended periods (days). This is particularly important in light of the existence of pathogens that have coagulopathy properties. Thus, dressings that provide effective hemostasis and reduction in the frequency of dressing changes, whereas exerting robust antimicrobial activity are of interest for PFC. Highly cleaned and sterile unbleached cotton has constituents not found in bleached cotton that are beneficial to the hemostatic and inflammatory stages of wound healing. Here, we demonstrate two approaches to cotton-based antimicrobial dressings that utilize the unique components of the cotton fiber with simple modification to confer a high degree of hemostatic and antimicrobial efficacy. Methods Spun bond nonwoven unbleached cotton was treated using traditional pad dry cure methods to add ascorbic acid, zeolite (NaY) with pectin, calcium chloride, and sodium carbonate/calcium chloride. Similarly, nanosilver-embedded cotton fiber was blended with pristine cotton fibers at various weight ratios to produce hydroentangled nonwoven fabrics. The resulting treated fabrics were assessed for hemostasis using thromboelastographic clotting assays and antimicrobial activity utilizing American Association of Textile Chemists and Colorists 100. Results Zeolite-containing dressings possessed significant hemostatic activity, whereas ascorbic acid- and silver-containing dressings reduced Gram-positive and Gram-negative organism numbers by several logs. Conclusion Based on this study, a multilayered hemostatic dressing with antimicrobial properties is envisioned. This dressing would be safe, would be economical, and have a stable shelf-life that would be conducive for using PFC.

Antimicrobial and Hemostatic Activities of Cotton-Based Dressings Designed to Address Prolonged Field Care Applications.

The development of affordable, effective, and environmentally friendly barrier fabrics is a current goal in antimicrobial textile development. The discovery of new routes to achieve non-toxic naturally occurring molecules with antimicrobial activity is of interest in the development of materials that promote wound healing, improve hygiene, and offer protection against nosocomial infection. Highly cleaned and sterile unbleached cotton has constituents that produce hydrogen peroxide at levels commensurate with those that favor cell signaling in wound healing. Here, we show the antimicrobial and antiviral properties of spunlaced griege cotton-containing nonwovens treated with ascorbic acid formulations. The mechanism of action occurs through the promotion of enhanced hydrogen peroxide activity. The levels of hydrogen peroxide activity afford antimicrobial activity against Gram-negative and Gram-positive bacteria and antiviral activity against MS2 bacteriophages. Spun-bond nonwoven unbleached cotton was treated with ascorbic acid using traditional pad-dry-cure methods. An assessment of antibacterial and antiviral activity against Staphylococcus aureus, Klebsiella pneumoniae, and MS2 bacteriophages with the AATCC 100 test method showed a 99.99% inhibitory activity. An approach to the covalent attachment of ascorbic to cellulose through citric acid crosslinking chemistry is also discussed. Thus, a simple, low-cost approach to antimicrobial and antiviral cotton-based nonwovens applicable to dressings, nosocomial barrier fabrics, and face masks can be adopted by combining ascorbic acid with spunlace greige cotton nonwoven fabrics.

/pdf/ascorbic-acid-as-an-adjuvant-to-unbleached-cotton-promotes-2cy9tii2.pdf

Ascorbic Acid as an Adjuvant to Unbleached Cotton Promotes Antimicrobial Activity in Spunlace Nonwovens

Uncontrolled hemorrhage is the leading cause of preventable combat-related deaths. The vast majority of these deaths occur in the field before the injured can be transported to a treatment facility. Early control of hemorrhage remains the most effective strategy for treating combat casualties. A number of hemostatic agents have recently been deployed to the warfront that can be used to arrest bleeding before surgical control of the source. The purpose of this article is to summarize the background information regarding these hemostatic agents, indications and rationale for their use, and characteristics of these products that may impact effectiveness.

/pdf/hemorrhage-control-in-the-battlefield-role-of-new-hemostatic-lhdsr16f03.pdf

Hemorrhage Control in the Battlefield: Role of New Hemostatic Agents

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Development of a Nonwoven Hemostatic Dressing Based on Unbleached Cotton: A De Novo Design Approach

Antimicrobial and Hemostatic Activities of Cotton-Based Dressings Designed to Address Prolonged Field Care Applications.

Ascorbic Acid as an Adjuvant to Unbleached Cotton Promotes Antimicrobial Activity in Spunlace Nonwovens

Hemorrhage Control in the Battlefield: Role of New Hemostatic Agents