Acquired FXIII Deficiency is Associated with High Morbidity.

BACKGROUND: A factor XIII (FXIII) level >30% is considered necessary to prevent spontaneous bleeding. Bleeding is also a risk in patients with acquired FXIII deficiency, but the hemostatic level of FXIII in this context remains to be determined. METHODS: We retrospectively analyzed all patients diagnosed with acquired FXIII deficiency at a large hospital over 3 years (study ID NCT04416594, http://www.clinicaltrials.gov) and assessed clinical data to identify the best cut-off point for FXIII activity to distinguish between low and high risk of major bleeding in a mixed medical and surgical population. RESULTS: Of the 97 patients who experienced bleeding despite a normal coagulation test, 43.2% had FXIII activity <70%. FXIII activity was significantly lower in surgical patients and patients admitted to the intensive care unit (ICU). Low FXIII activity was significantly associated with long ICU stays and a high incidence of major bleeding. CONCLUSION: Acquired FXIII deficiency is associated with high morbidity. The hemostatic level of FXIII in the setting of acquired FXIII deficiency might be above 30%.

Topical Hemostatic Agents at Time of Obstetric and Gynecologic Surgery: ACOG Committee Opinion, Number 812.

There are three broad categories of hemostatic agents: 1) caustic, 2) physical, and 3) biologic. Because of the paucity of data on the use of topical hemostatic agents in gynecologic and obstetric surgery, indications for use are extrapolated from data on the use of these agents in other types of surgeries and are based on expert opinion. Topical hemostatic agents can be a useful adjunct to assist in the management of intraoperative bleeding in select circumstances. Topical hemostatic agents most commonly are used in situations where the use of electrocautery or sutures for hemostatic control of surgical bleeding is not ideal or safe, including bleeding in areas with nearby vulnerable structures or in the presence of diffuse bleeding from peritoneal surfaces or cut surfaces of solid organs. When managing intraoperative bleeding, there is no substitute for meticulous surgical technique. When possible, the surgeon should attempt to control intraoperative bleeding with sutures, clips, or electrosurgery before the use of hemostatic agents. It is essential for surgeons to understand the appropriate use, contraindications, and cost of these agents in order to make the most informed decision for patient care.

Topical Hemostatic Agents at Time of Obstetric and Gynecologic Surgery: ACOG Committee Opinion Summary, Number 812.

There are three broad categories of hemostatic agents: 1) caustic, 2) physical, and 3) biologic. Because of the paucity of data on the use of topical hemostatic agents in gynecologic and obstetric surgery, indications for use are extrapolated from data on the use of these agents in other types of surgeries and are based on expert opinion. Topical hemostatic agents can be a useful adjunct to assist in the management of intraoperative bleeding in select circumstances. Topical hemostatic agents most commonly are used in situations where the use of electrocautery or sutures for hemostatic control of surgical bleeding is not ideal or safe, including bleeding in areas with nearby vulnerable structures or in the presence of diffuse bleeding from peritoneal surfaces or cut surfaces of solid organs. When managing intraoperative bleeding, there is no substitute for meticulous surgical technique. When possible, the surgeon should attempt to control intraoperative bleeding with sutures, clips, or electrosurgery before the use of hemostatic agents. It is essential for surgeons to understand the appropriate use, contraindications, and cost of these agents in order to make the most informed decision for patient care.

Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use. Final order.

The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Hospital economic impact from hemostatic matrix usage in cardiac surgery.

OBJECTIVE: Improved health outcomes can result in economic savings for hospitals and payers. While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated, evaluations of their economic benefit are limited. This study quantifies the cost consequences to hospitals, based on clinical outcomes, from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery. RESEARCH DESIGN AND METHODS: Applying clinical outcomes from a prospective randomized clinical trial, a cost consequence framework was utilized to model the economic impact of comparator groups. From that study, clinical outcomes were obtained and analyzed for a flowable hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation) vs non-flowable topical hemostats (SURGICEL Nu-Knit, Ethicon-Johnson & Johnson; GELFOAM, Pfizer). Costing analyses focused on the following outcomes: complications, blood transfusions, surgical revisions, and operating room (OR) time. Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data. Comparator group variability in cost consequences (i.e., cost savings) was calculated based on annualized impact and scenario testing. RESULTS: RESULTS suggest that if a flowable hemostatic matrix (rather than a non-flowable hemostat) was utilized exclusively in 600 mixed cardiac surgeries annually, a hospital could improve patient outcomes by a reduction of 33 major complications, 76 minor complications, 54 surgical revisions, 194 transfusions, and 242 h of OR time. These outcomes correspond to a net annualized cost consequence savings of $5.38 million, with complication avoidance as the largest contributor. CONCLUSIONS: This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents. These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix, rather than a non-flowable topical hemostat, in cardiac surgery.

Mecanismo de ação dos agentes hemostáticos locais e adesivos tissulares / Mechanism of action of topical hemostatic and adhesive tissue agents

Existe disponível, atualmente, grande variedade de agentes hemostáticos locais, vedantes e adesivos tissulares. O conhecimento do mecanismo de ação de cada um deles é primordial para a escolha do agente ideal para cada tipo de hemorragia. Os agentes hemostáticos são divididos em dois grupos, de acordo com seus mecanismos de ação: a) ativos - os ativadores das plaquetas; b) passivos ou mecânicos - promotores da absorção do sangue, aumentando o seu volume e pressionando o local do sangramento. Os agentes ativos podem ser usados nas coagulopatias, utilizam componentes do plasma humano como trombina e fibrina e, por isto, podem transmitir doenças virais e são mais dispendiosos. Os agentes mecânicos, por criarem uma barreira ao sangramento devido ao aumento de volume, não podem ser usados em áreas confinadas. Neste artigo são feitas considerações sobre as características dos vários agentes hemostáticos...

A wide variety of topical hemostatic agents, sealants, and tissue adhesives is currently available. Knowledge of the mechanism of action of each of them is essential for choosing the ideal agent for each type of hemorrhage. Hemostatic agents are divided into two groups accordingto mechanism of action: a) active, which activates platelets b) passive or mechanical, which promotes blood absorption, increase in volume, and creates pressure on the site of the bleeding. Active agents can be used in coagulopathies and use human plasma components like thrombin and fibrin. As such, they can transmit viral diseases and are more expensive.Mechanical agents, because they stop the bleeding due to volume increase cannot be used in confined areas. This article considers the characteristics of various hemostatic agents...

Prenatal and developmental effect of high molecular weight chitosan (HMWCS) to mice.

High molecular weight chitosan (HMWCS) is effective at hemostasis and wound healing, and will be potentially used on injured internal organs. To study its prenatal and developmental effect in vivo, forty-four ICR pregnant mice per group were singly injected intraperitoneally at 0, 125, 500 or 2000 mg/kg body weight, respectively, on gestation day 6 (GD6). Clinical signs, reproductive capacity, fetus and infant developments, and histopathological changes were then observed. The results showed that the treatment of HMWCS could decrease body weights and food consumptions, and induce diarrhea, vaginal bleeding, and some other adverse effects in F0 mice. For the emaciation and threatened abortion of pregnant mice, the numbers of live fetuses and early resorption were reduced significantly in HMWCS groups. However, the developments of F1 and F2 mice were not affected, except for lower weights of the body and some organs. In addition, the NOAEL of HMWCS in maternal toxicity was considered to be less than 125 mg/kg, and the NOAEL in developmental toxicity was 125 mg/kg.

Inherited platelet disorders and oral health.

Platelets play a key role in thrombosis and hemostasis. Accumulation of platelets at the site of vascular injury is the first step in the formation of hemostatic plugs, which play a pivotal role in preventing blood loss after injury. Platelet adhesion at sites of injury results in spreading, secretion, recruitment of additional platelets, and formation of platelet aggregates. Inherited platelet disorders are rare causes of bleeding syndromes, ranging from mild bruising to severe hemorrhage. The defects can reflect deficiency or dysfunction of platelet surface glycoproteins, granule contents, cytoskeletal proteins, platelet pro-coagulant function, and signaling pathways. For instance, Bernard-Soulier syndrome and Glanzmann thrombasthenia are attributed to deficiencies of glycoprotein Ib/IX/V and GPIIb/IIIa, respectively, and are rare but severe platelet disorders. Inherited defects that impair platelet secretion and/or signal transduction are among the most common forms of mild platelet disorders and include gray platelet syndrome, Hermansky-Pudlak syndrome, and Chediak-Higashi syndrome. When necessary, desmopressin, antifibrinolytic agents, and transfusion of platelets remain the most common treatment of inherited platelet disorders. Alternative therapies such as recombinant activated factor VII are also available for a limited number of situations. In this review, we will discuss the management of patients with inherited platelet disorders in various clinical situations related to dental cares, including surgical intervention.

Hemostats, sealants, and adhesives III: a new update as well as cost and regulatory considerations for components of the surgical toolbox.

The hemostat, sealant, and adhesive components of the surgical toolbox continue to evolve and enter clinical practice at a rapid rate. The goal of this comprehensive, sequential review is to update these components to include those now available (February 2012) as well as to explore cost and regulatory factors that impact the development and use of these materials. A unique system of definitions for organizing these components based on group, category, and class is used as a means of improving the understanding and appropriate use of these materials. The system will be used here to present the most recent additions to the toolbox, which are evaluated based on safety, efficacy, usability, and cost. These new additions include pooled human plasma fibrinogen and thrombin embedded in an equine collagen patch for cardiac surgical hemostasis, polyethylene glycol (PEG) and human serum albumin for lung surgical pneumostasis, modified PEG and trilysine amine for spinal sealing, octyl and butyl lactoyl cyanoacrylate for vascular sealing, and a variety of octyl and butyl cyanoacrylates with or without dyes and/or polyester mesh for skin closure with the creation of a bacterial barrier. The system of definitions will also be used to clarify key strategies in the current health care environment for reducing costs and for increasing understanding of Food and Drug Administration regulatory decisions for these materials.

Hemostatic agents.

Hemostasis is an integral and very important aspect of surgical practice. As a rule, most bleeding from dental surgery can be controlled by pressure. When the application of pressure does not yield satisfactory results, or where more effective hemostasis is required, hemostatic agents are used. These agents act to stop bleeding either mechanically or by augmenting the coagulation cascade. Some of the newer agents that are available to the dental profession have been presented.

Empleo del ácido tranexámico post-exodoncias / Postsurgical use of tranexamic acid

Este estudio clínico se basó en la evaluación de la eficacia del ácido tranexámico como elemento coadyuvante hemostático post-exodoncias.

Hemorrhage control in the battlefield: role of new hemostatic agents.

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.