Hemostatic Control Research Articles

A randomized comparison of an adhesive gelatin sponge and a plain collagen sponge for hemostatic control during canine liver surgery.

To compare the effectiveness of a modified surface gelatin sponge to a plain collagen sponge for hemostasis of parenchymal hepatic bleeding. Prospective, randomized trial of two hemostatic agents. A total of 45 dogs undergoing elective liver surgery were randomly allocated into two groups: 22 in the adhesive gelatin (AG) group and 23 in the plain collagen (PC) group. A total of 20 patients per group underwent liver biopsy to create a uniformly sized bleeding surface, with the remaining patients (AG = 2, PC = 3) undergoing liver lobectomy. Evaluation of hemostatic effectiveness and tissue adhesion of each sponge type was performed by the operating surgeon using structured scoring systems. Hemostatic parameters were primarily evaluated at the liver biopsy site to maintain homogeneity of bleeding surface size. For the liver biopsy group (n = 40), 5 min after hemostatic sponge application, 10/20 dogs were bleeding in the PC group, compared to 2/20 in AG group (p = .0138). The PC bleeding was significantly higher than AG across the 3 to 6 min evaluation period (p < .001). When surgeons tested the adhesion of the sponge across the whole cohort (n = 45), AG scored 2 (of 3) against 1 for PC (p < .001). In group PC, 5/23 sponges dislodged during abdominal lavage and preparations for closure and had to be replaced due to recurrence of bleeding, compared with no AG sponges dislodging (p = .042). There were no further complications related to the use of either sponge. In the dogs with hepatic parenchymal incision, use of an adhesive gelatin sponge improved intraoperative attachment and haemostatic effectiveness, compared to a collagen sponge. Based on our clinical experience in these cases, adhesive gelatin sponges could be considered an effective option when selecting a hemostatic agent for liver surgery in dogs.

Efficacy, safety, and quality of life 4 years after valoctocogene roxaparvovec gene transfer for severe hemophilia A in the phase 3 GENEr8-1 trial

BackgroundValoctocogene roxaparvovec, an adeno-associated virus-mediated gene therapy for severe hemophilia A, enables endogenous factor VIII (FVIII) expression and provides bleed protection. ObjectivesDetermine valoctocogene roxaparvovec durability, efficacy, and safety 4 years post-treatment. MethodsIn the phase 3 GENEr8-1 trial, 134 adult males with severe hemophilia A without inhibitors and previously using FVIII prophylaxis received a 6x1013 vg/kg infusion of valoctocogene roxaparvovec. Efficacy endpoints included annualized bleed rate (ABR), annualized FVIII infusion rate, FVIII activity, and the Haemophilia-Specific Quality of Life Questionnaire for Adults (Haemo-QOL-A). Adverse events (AEs) and immunosuppressant use were assessed. Change from baseline was assessed after participants discontinued prophylaxis (scheduled for week 4). ResultsMedian follow-up was 214.3 weeks; 2 participants discontinued since the previous data cutoff. Declines from baseline in mean treated ABR (−82.6%; P<0.0001) and annualized FVIII infusion rate (−95.5%; P<0.0001) were maintained from previous years in the primary analysis population of 112 participants who enrolled from a noninterventional study. During year 4, 81/110 rollover participants experienced 0 treated bleeds. Week 208 mean and median chromogenic FVIII activity were 16.1 IU/dL and 6.7 IU/dL, respectively, in 130 modified intention-to-treat (mITT) participants. Seven participants resumed prophylaxis since the previous data cutoff. Mean change from baseline to week 208 in Haemo-QOL-A Total Score (P<0.0001) remained clinically meaningful for mITT participants. Alanine aminotransferase elevation was the most common AE during year 4 (56/131 participants); none required immunosuppressants. ConclusionsValoctocogene roxaparvovec provides persistent FVIII expression, hemostatic control, and health-related quality of life improvements with no new safety signals.

Acquired hemophilia A as a disease of the elderly: A comprehensive review of epidemiology, pathogenesis, and novel therapy

AbstractAcquired hemophilia A (AHA) is a rare autoimmune bleeding disorder characterized by the development of neutralizing autoantibodies (inhibitors) against coagulation factor VIII (FVIII). This review provides an in-depth exploration of AHA, covering its epidemiology, pathogenesis, clinical presentation, diagnosis, complications, and treatment strategies, focusing on recent advancements. AHA can manifest in both men and women with no prior bleeding history. The annual incidence is estimated to be approximately 1 case per million individuals in the general population. The incidence increases significantly with age: the incidence among individuals aged 60 years or older is approximately 3 to 4 cases per million individuals per year. Typically, patients present with an acquired bleeding disorder that is characterized by an isolated, prolonged activated partial thromboplastin time stemming from FVIII deficiency. Diagnosis relies on the detection of neutralizing antibodies using the Nijmegen-modified Bethesda assay. Hemostatic control strategies involve bypassing agents like recombinant activated factor VII, activated prothrombin complex concentrate, and recombinant porcine FVIII for bleeding patients. Emicizumab, a novel bypassing agent, exhibits several potential advantages. In the realm of immunosuppressive treatment for inhibitor eradication, the CyDRi regimen emerged as a remarkable advancement, significantly enhancing the outlook for the management of AHA even in the elderly frail population.

Tissue factor pathway inhibitor - cofactor-dependent regulation of the initiation of coagulation.

In humans, tissue factor pathway inhibitor (TFPI) exists in two alternatively spliced isoforms, TFPIα and TFPIβ. TFPIα consists of three Kunitz domains (K1, K2 and K3) and a highly basic C-terminal tail. K1 inhibits the tissue factor-activated factor VII complex, K2 specifically inhibits activated factor X, K3 is essential for interaction with its cofactor, protein S, and the basic C-terminus is binds factor V-short (FV-short) with high affinity. TFPIβ consists of K1 and K2 that is glycosylphosphatidylinositol anchored directly to cell surfaces. This review explores the structure/function of TFPI and its cofactors (protein S and FV-short), and the relative contributions that different TFPI isoforms may play in haemostatic control. Recent data have underscored the importance of TFPIα function and its reliance on its cofactors, protein S and FV-short, in influencing haemostatic control as well as bleeding and thrombotic risk. TFPIα is likely the most important pool of TFPI in modifying the risk of thrombosis and bleeding. TFPIα forms a trimolecular complex with FV-short and protein S in plasma. FV-short expression levels control the circulating levels of TFPIα, whereas protein S exerts essential cofactor mediated augmentation of it anticoagulant function.

Emergency Anesthesiology Encounters, Care Practices, and Outcomes for Patients with Firearm Injuries: A 9-Year Single-Center US Level 1 Trauma Experience.

Firearm injuries cause significant morbidity and mortality. Patients with firearm injuries require urgent/emergency operative procedures but the literature incompletely describes how anesthesia care and outcomes differ between high acuity trauma patients with and without firearm injuries. Our objective was to examine anesthesia care, resource utilization, and outcomes of patients with acute firearm injuries compared to nonfirearm injuries. We conducted a retrospective cross-sectional study of patients ≥18 years admitted to a regional Level 1 trauma center between 2014 and 2022 who required operative management within the first 2 hours of hospital arrival. We examined clinical characteristics, anesthesiology care practices, and intra- and postoperative outcomes of patients with firearm injuries compared to patients with nonfirearm injuries. Over the 9-year study period, firearm injuries accounted for the largest yearly average increase in trauma admissions (firearm 10.1%, blunt 3.2%, other 1.3%, motor-vehicle crash 0.9%). Emergency anesthesiology care within 2 hours of arrival was delivered to 4.7% of injured patients (2124; 541 firearm [25.4%] and 1583 [74.5%] nonfirearm). Patients with firearm injuries were younger (30 [23-40] years vs 41 [29-56] years; P < .0001), male (90% vs 75%; P < .0001), direct admissions from scene (78% vs 62%; P < .0001), had less polytrauma (10% vs 22%; P < .0001), arrived after hours (73% vs 63%; P < .0001), and received earlier anesthesiology care (0.4 [0.3-0.7] vs 0.9 [0.5-1.5] hours after arrival; P < .0001). Patients with firearm injuries more often received invasive arterial (83% vs 77%; P < .0001) and central venous (14% vs 10%; P = .02) cannulation, blood products (3 [0-11] vs 0 [0-7] units; P < .0001), tranexamic acid (30% vs 22%; P < .001), as well as had higher estimated blood loss (500 [200-1588] mL vs 300 [100-1000] mL; P < .0001), and were transferred to the intensive care unit (ICU) more frequently (83% vs 77%; P < .001) than patients with nonfirearm injuries. Intraoperative mortality was comparable (6% firearm vs 4% nonfirearm) but postoperative mortality was lower for patients with firearm injuries who survived the intraoperative course (6% vs 14%; P < .0001). Comparatively, more patients with firearm injuries were discharged to home, or to jail (P < .001). Over the study period, anesthesiologists increasingly cared for patients with firearm injuries, who often present outside of daytime hours and require urgent operative intervention. Operating room readiness and high-intensity resuscitation capacity, such as access to hemostatic control measures, are critical to achieving intraoperative survival and favorable postoperative outcomes, particularly for patients with firearm injuries.

Shoeshine maneuver for cystic duct dissection: a simple technique to make Calot-triangle dissection smooth.

Laparoscopic cholecystectomy, introduced in 1985 by Prof. Dr. Erich Mühe, has become the gold standard for treating chronic symptomatic calculous cholecystopathy and acute cholecystitis, with an estimated 750,000 procedures performed annually in the United States of America. The risk of iatrogenic bile duct injury persists, ranging from 0.2 to 1.3%. Risk factors include male gender, obesity, acute cholecystitis, previous hepatobiliary surgery, and anatomical variations in Calot's triangle. Strategies to mitigate bile duct injury include the Critical View of Safety and fundus-first dissection, along with intraoperative cholangiography and alternative approaches like subtotal cholecystectomy. This paper introduces the shoeshine technique, a maneuver designed to achieve atraumatic exposure of anatomical structures, local hemostatic control, and ease of infundibulum mobilization. This technique involves the use of a blunt dissection tool and gauze to create traction and enhance visibility in Calot's triangle, particularly beneficial in cases of severe inflammation. Steps include using the critical view of safety and Rouviere's sulcus line for orientation, followed by careful dissection and traction with gauze to maintain stability and reduce the risk of instrument slippage. The technique, routinely used by the authors in over 2000 cases, has shown to enhance patient safety and reduce bile duct injury risks. The shoeshine technique represents a simple and easy way to apply maneuver that can help surgeon during laparoscopic cholecystectomies exposing the hepatocystic area and promote blunt dissection.

Valoctocogene roxaparvovec gene therapy provides durable haemostatic control for up to 7 years for haemophilia A.

Valoctocogene roxaparvovec is an adeno-associated virus vector serotype 5 (AAV5)-mediated gene therapy approved for severe haemophilia A (HA). To report the safety and efficacy of valoctocogene roxaparvovec 7 years after dosing in a phase 1/2 clinical study (NCT02576795). Males ≥18 years with severe HA (factor VIII [FVIII] ≤1 international unit [IU]/dL) who were previously receiving exogenous FVIII and had no history of FVIII inhibitors or anti-AAV5 antibodies received valoctocogene roxaparvovec treatment and were followed for 7 (6×1013vg/kg; n=7) and 6 (4×1013vg/kg; n=6) years. In the last year, one participant in each cohort reported treatment-related adverse events (AEs): grade 1 (G1) hepatomegaly (6×1013), and G1 splenomegaly and G1 hepatic steatosis (4×1013). During all follow-up, mean annualized treated bleeds and exogenous FVIII infusion rates were ≥88% lower than baseline values. At years 7 and 6, mean (median) FVIII activity (chromogenic assay) was 16.2 (10.3) and 6.7 (7.2) IU/dL in the 6×1013 (n=5) and 4×1013 (n=4) cohorts, respectively, corresponding to mild haemophilia. Regression analyses of the last year estimated rate of change in FVIII activity was -0.001 and -0.07IU/dL/week for the 6×1013 and 4×1013 cohorts, respectively. Two participants (6×1013) resumed prophylaxis in year 7: one after a non-treatment-related G4 serious AE of spontaneous internal carotid artery bleed, and the other to manage bleeds and FVIII activity. The safety and efficacy of valoctocogene roxaparvovec remain generally consistent with previous reports, with good haemostatic control for most participants. Two participants returned to prophylaxis.

Application of a New Hemostatic Clip to Prevent Delayed Bleeding After Endoscopic Sphincterotomy: A Propensity Score-matched Analysis.

Delayed bleeding after endoscopic sphincterotomy (ES) is a serious adverse event of endoscopic retrograde cholangiopancreatography. The aim of this study is to evaluate the effect of prevent delayed bleeding of hemostatic clip (Sureclip) after ES. Consecutive patients diagnosed with common bile duct stones with a high risk of delayed bleeding who received ES from January 1, 2013, to July 31, 2022, were analyzed retrospectively. A 1:1 propensity score-matching analysis and logistic regression analysis were used. The patients were allocated into the hemostatic clip and control groups. The rate of delayed bleeding, hyperamylasemia, pancreatitis, and hemostatic clip closing the bile duct or pancreatic duct by mistake were compared between the 2 groups. Overall, 161 and 232 patients were allocated to the control and hemostatic clip groups, respectively, propensity score matching created 120 matched pairs. The rate of delayed bleeding was significantly lower in the hemostatic clip group than in the control group (1.67% vs. 7.5%, P =0.031). After adjusting for confounding factors, logistic regression showed hemostatic clip was associated with decreased odds of delayed bleeding (0.134, 95% CI: 0.025-0.719). No case of hemostatic clip closing the bile duct or pancreatic duct by mistake occurred in the hemostatic clip group. No significant differences were observed in postoperative hyperamylasemia and pancreatitis between the 2 groups. This study indicated that the prophylactic application of a hemostatic clip is associated with a significantly reduced rate of delayed bleeding after ES in high-risk patients. This approach did not increase the risk of adverse event.

INVESTIGATING THE RELATIONSHIP BETWEEN BLEEDING, CLOTTING, AND COAGULOPATHY DURING AUTOMATED PARTIAL REBOA STRATEGIES IN A HIGHLY LETHAL PORCINE HEMORRHAGE MODEL.

Background: Death due to hemorrhagic shock, particularly, noncompressible truncal hemorrhage, remains one of the leading causes of potentially preventable deaths. Automated partial and intermittent resuscitative endovascular balloon occlusion of the aorta (i.e., pREBOA and iREBOA, respectively) are lifesaving endovascular strategies aimed to achieve quick hemostatic control while mitigating distal ischemia. In iREBOA, the balloon is titrated from full occlusion to no occlusion intermittently, whereas in pREBOA, a partial occlusion is maintained. Therefore, these two interventions impose different hemodynamic conditions, which may impact coagulation and the endothelial glycocalyx layer. In this study, we aimed to characterize the clotting kinetics and coagulopathy associated with iREBOA and pREBOA, using thromboelastography (TEG). We hypothesized that iREBOA would be associated with a more hypercoagulopathic response compared with pREBOA due to more oscillatory flow. Methods: Yorkshire swine (n = 8/group) were subjected to an uncontrolled hemorrhage by liver transection, followed by 90 min of automated pREBOA, iREBOA, or no balloon support (control). Hemodynamic parameters were continuously recorded, and blood samples were serially collected during the experiment (i.e., eight key time points: baseline (BL), T0, T10, T30, T60, T90, T120, T210 min). Citrated kaolin heparinase assays were run on a TEG 5000 (Haemonetics, Niles, IL). General linear mixed models were employed to compare differences in TEG parameters between groups and over time using STATA (v17; College Station, TX), while adjusting for sex and weight. Results: As expected, iREBOA was associated with more oscillations in proximal pressure (and greater magnitudes of peak pressure) because of the intermittent periods of full aortic occlusion and complete balloon deflation, compared to pREBOA. Despite these differences in acute hemodynamics, there were no significant differences in any of the TEG parameters between the iREBOA and pREBOA groups. However, animals in both groups experienced a significant reduction in clotting times (R time: P < 0.001; K time: P < 0.001) and clot strength (MA: P = 0.01; G: P = 0.02) over the duration of the experiment. Conclusions: Despite observing acute differences in peak proximal pressures between the iREBOA and pREBOA groups, we did not observe any significant differences in TEG parameters between iREBOA and pREBOA. The changes in TEG profiles were significant over time, indicating that a severe hemorrhage followed by both pREBOA and iREBOA can result in faster clotting reaction times (i.e., R times). Nevertheless, when considering the significant reduction in transfusion requirements and more stable hemodynamic response in the pREBOA group, there may be some evidence favoring pREBOA usage over iREBOA.

The Use of Bone Wax in Hemostatic Control for Total Knee and Hip Arthroplasties: A Systematic Review.

Background/Objectives: Blood loss can be a serious complication in patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA). Various methods are used by surgeons to achieve hemostatic control in these patients. Complications are associated with perioperative blood loss. In this systematic review, we examined the efficacy of using bone wax to control bleeding in patients undergoing THA and TKA. Methods: The PRISMA model was used to systematically identify and aggregate articles for this study. The PubMed and EMBASE databases were used to search individual studies that examined the use of bone wax in THA or TKA. After applying the search term "bone wax", 2478 articles were initially identified. After inclusion and exclusion criteria were applied, three articles were aggregated for this systematic review. Results: The use of bone wax in THA and TKA decreased blood loss in patients undergoing these operations. Postoperative blood loss following surgery was lower in the bone wax groups compared to the control groups as well. Patients in the bone wax groups also required fewer blood transfusions than those who did not receive bone wax. Conclusions: Bone wax appears to be another modality that can be used by physicians to maintain hemostatic control in THA or TKA patients. Reduced blood loss and transfusion rates in surgery can increase patient outcomes. More studies are needed to examine the efficacy of bone wax in comparison with other hemostatic tools.

Transitioning from emicizumab prophylaxis to valoctocogene roxaparvovec gene therapy: A simulation study for individuals with severe haemophilia A.

Valoctocogene roxaparvovec, a gene therapy evaluated in the phase 3 GENEr8-1 trial, supports endogenous factor VIII (FVIII) production to prevent bleeding in people with severe haemophilia A. Individuals receiving emicizumab, an antibody mimicking the function of activated FVIII, were excluded from GENEr8-1 enrolment since emicizumab was an investigational therapy at the time of trial initiation. Utilize pharmacokinetic simulations to provide guidance on best practices for maintaining haemostatic control while transitioning from emicizumab prophylaxis to valoctocogene roxaparvovec. To estimate bleeding risk at weekly intervals following valoctocogene roxaparvovec infusion, a published emicizumab pharmacokinetic model was used to simulate emicizumab concentrations and merged with FVIII activity time-course data for participants in GENEr8-1. The analysis investigated three approved emicizumab dosing regimens for two transition scenarios that varied whether the last dose of emicizumab was administered on the same day or 4weeks after valoctocogene roxaparvovec infusion. Simulations demonstrated administering the last emicizumab dose the day of valoctocogene roxaparvovec infusion and 4weeks after offered similar levels of haemostatic control, and bleeding risk was similar for all emicizumab dosing regimens. An algorithm was developed to provide guidance for discontinuation of emicizumab. Theoretical cases based on GENEr8-1 participants are presented to illustrate how decisions may vary among individuals. Pharmacokinetic simulations demonstrated no clinically meaningful difference in bleeding risk caused by decaying emicizumab levels and rising gene therapy-derived endogenous FVIII for all examined emicizumab doses and dosing regimens. Therefore, multiple approaches can safely transition individuals from emicizumab prophylaxis to valoctocogene roxaparvovec.

An Algorithm for Control of Excessive Perioperative Bleeding and Ecchymosis in Rhinoplasty Patients Based on 4 Decades of Experience.

Persistent intraoperative bleeding, excessive post-operative ecchymosis, epistaxis, or blood collection in the supratip area increases the complexity of rhinoplasty, causing suboptimal outcomes. We present an intraoperative bleeding management algorithm developed by the senior author (B.G.) based on 43 years of experience and assess its efficacy in achieving hemostatic control through 103 consecutive cases. A retrospective chart review was conducted on 103 consecutive patients who had undergone septorhinoplasty by a single surgeon. Patient demographics, coagulopathies, medications, diet, intraoperative use of tranexamic acid (TXA), desmopressin (DDAVP), Vitamin K, and post-operative complications were reviewed. Twenty-six (25.2%) patients did not receive intraoperative hemostatic agents. Twenty-six (25.2%) patients required TXA only, three (2.91%) patients were given DDAVP only, one (0.97%) patient received Vitamin K only, and forty-six (44.7%) patients required both TXA and DDAVP. One (0.97%) patient needed TXA, DDAVP, and vitamin K. Intraoperative bleeding was controlled in all patients. One patient with known factor 11 deficiency received both TXA and DDAVP intraoperatively but did not require fresh frozen plasma. Intraoperative bleeding was controlled by first administering 10 mg/kg of TXA intravenously, followed by DDAVP with a maximum dose of 0.3 mcg if needed, and 10 mg of Vitamin K if bleeding persisted. Patients with known type I or IIa Von Willebrand disease received DDAVP preoperatively. No patient experienced post-operative epistaxis, thromboembolism, or other associated complications. The algorithm of TXA, DDAVP, and Vitamin K is effective in controlling excessive intraoperative bleeding, post-operative ecchymosis, and epistaxis. IV.

VNOTES Radical Hysterectomy: A New Approach to Cervical Cancer

To demonstrate how a radical hysterectomy with sentinel node resection for cervical cancer can be performed via vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). Demonstration of the technique in 10 steps. making use of narrated original video footage SETTING: The surgical treatment of cervical cancer is traditionally performed via one of the following techniques: Wertheim radical hysterectomy via laparotomy, Schauta radical hysterectomy vaginally, laparoscopic radical hysterectomy or robotic radical hysterectomy. The results of the LACC trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open radical hysterectomy among women with early-stage cervical Cancer [1]. For endometrial cancer, a vNOTES retroperitoneal approach to sentinel node resection was first published in 2019 [2]. Based on the experience with this approach and with Schauta-Stoeckel radical hysterectomy for cervical cancer [3], a new approach was developed to perform a radical hysterectomy via vNOTES whereby most of the procedure is performed retroperitoneally [4]. This video article demonstrates in 10 steps how a radical hysterectomy via vNOTES is performed. Radical hysterectomy via vNOTES demonstrated making use of original video footage of a 57-year-old woman operated on for cervical adenocarcinoma 7 weeks after a LEEP cone. The steps of the procedure are: 1. Vaginal cuff creation, 2. Development of lateral retroperitoneal space and sentinel node resection, 3. Uterine artery and vein transection, 4. Hypogastric nerve dissection, 5. Development of central retroperitoneal space and rectum dissection, 6. Posterior colpotomy, 7. Parametrium dissection, 8. Bladder pillar dissection, 9. Anterior colpotomy, 10. Salpingo-oophorectomy or salpingectomy. 3 Patients were so far treated by this new technique that allowed for good hemostatic control. vNOTES enables a potentially less invasive approach to radical hysterectomy performed largely retroperitoneally and completely transvaginally, leaving no visible scars. The endoscopic approach offers excellent visualization of the retroperitoneal and parametrial anatomy. This is a new approach that requires further validation and should only be performed in a research setting, taking into account the current reservations about endoscopic surgery for cervical cancer resulting from the LACC trial. VIDEO ABSTRACT.

Safety and feasibility of cystic artery control with bipolar electrocauterization during laparoscopic cholecystectomy

Background Securing the cystic artery in laparoscopic cholecystectomy can be achieved with clips, electrocautery, and ultramodern vessel-sealing energy devices. Bipolar electrocoagulation of cystic artery is safe and a cost-effective measure in developing countries. Patients and methods The rationale of this current prospective study was to establish the safety and feasibility of bipolar electrocautery in securing cystic artery during laparoscopic cholecystectomy in the local setting. Patients who were eligible for laparoscopic cholecystectomy at the Aswan University Hospital’s General Surgery Department were included. Results One hundred twenty patients were included in our study. Most of the participants were females, representing 93.33% of patients. The mean age of participants was 39.93±9.97 years, and 95.83% were overweight or obese. The mean±SD operative time was 88.57±28.06 min, and the median (interquartile range) was 84 min (33.25 min). Also, the mean±SD hospital stay was 1.12±0.57 days, and the median (interquartile range) was 1 (0) day. There was no intraoperative bleeding from the cystic artery nor from the right hepatic artery. No visceral injury was encountered. The success rate of the operation was 100%. None needed to be redone. No case needed conversion to open surgery. Conclusion In conclusion, in resource-constrained settings where the harmonic scalpel and all advanced bipolar instruments like ENSEAL and Legasure raise issues regarding cost and accessibility, bipolar diathermy is effective in hemostatic control of the cystic artery during laparoscopic cholecystectomy.

A sodium alginate - silk fibroin biosponge loaded with thrombin: Effective hemostasis and wound healing

In trauma first aid, rapid hemostasis is a priority, extricating patients from hemorrhagic shock and infection risks. This paper explores novel hemostatic materials, using ion-crosslinking and freeze-drying techniques. Iterative experiments determined optimal conditions for the temperature-variable mixing-freeze-drying chemical reaction of sodium alginate (SA)/silk fibroin (SF). We used SA, SA/SF, SA/SF-TB and commercial hemostatic sponge control samples to perform hemostasis experiments on rat liver injury and femoral artery injury models, and to perform wound healing experiments on rat back full-layer skin. The results showed that the hemostatic time and blood loss of SA/SF-TB group rats (liver hemorrhage model: 397.17 ± 34.80 mg, 77.83 ± 7.41 s; Femoral artery bleeding model: 940.33 ± 41.93 mg, 96.83 ± 4.07 s) was significantly better than other experimental groups, and similar to the commercial group. The wound healing experiment showed that the new granulation tissue thickness of SA/SF-TB group was thicker (380.39 ± 28.56 μm) at day 14. In addition, the material properties and biocompatibility of sponges were characterized by cell experiments and in vivo embedding experiments. All the results showed that the SA/SF-TB hemostatic sponge prepared in this study could not only seal the wound quickly and stop bleeding, but also promote the growth of epidermal cells and fibroblasts and accelerate wound healing. This new material solves the shortcomings of traditional materials such as low stability, limited shelf life, high unit price, and has good biocompatibility, easy preparation, rapid hemostasis and other excellent properties. Therefore, this innovative hemostatic material has great prospects and potential in clinical applications.

Surgical gestures can be used to assess surgical competence in robot-assisted surgery

To collect validity evidence for the assessment of surgical competence through the classification of general surgical gestures for a simulated robot-assisted radical prostatectomy (RARP). We used 165 video recordings of novice and experienced RARP surgeons performing three parts of the RARP procedure on the RobotiX Mentor. We annotated the surgical tasks with different surgical gestures: dissection, hemostatic control, application of clips, needle handling, and suturing. The gestures were analyzed using idle time (periods with minimal instrument movements) and active time (whenever a surgical gesture was annotated). The distribution of surgical gestures was described using a one-dimensional heat map, snail tracks. All surgeons had a similar percentage of idle time but novices had longer phases of idle time (mean time: 21 vs. 15 s, p < 0.001). Novices used a higher total number of surgical gestures (number of phases: 45 vs. 35, p < 0.001) and each phase was longer compared with those of the experienced surgeons (mean time: 10 vs. 8 s, p < 0.001). There was a different pattern of gestures between novices and experienced surgeons as seen by a different distribution of the phases. General surgical gestures can be used to assess surgical competence in simulated RARP and can be displayed as a visual tool to show how performance is improving. The established pass/fail level may be used to ensure the competence of the residents before proceeding with supervised real-life surgery. The next step is to investigate if the developed tool can optimize automated feedback during simulator training.

Safe and Efficacious Near Superhydrophobic Hemostat for Reduced Blood Loss and Easy Detachment in Traumatic Wounds.

Hemorrhage is the leading cause of trauma death, and innovation in hemostatic technology is important. The strongly hydrophobic carbon nanofiber (CNF) coating has previously been shown to have excellent hemostatic properties. However, the understanding of how CNF coating guides the coagulation cascade and the biosafety of CNF as hemostatic agents has yet to be explored. Here, our thrombin generation assay investigation showed that CNF induced fast blood coagulation via factor (F) XII activation of the intrinsic pathway. We further performed studies of a rat vein injury and demonstrated that the CNF gauze enabled a substantial reduction of blood loss compared to both the plain gauze and kaolin-imbued gauze (QuikClot). Analysis of blood samples from the model revealed no acute toxicity from the CNF gauze, with no detectable CNF deposition in any organ, suggesting that the immobilization of CNF on our gauze prevented the infiltration of CNF into the bloodstream. Direct injection of CNF into the rat vein was also investigated and found not to elicit overt acute toxicity or affect animal survival or behavior. Finally, toxicity assays with primary keratinocytes revealed minimal toxicity responses to CNF. Our studies thus supported the safety and efficacy of the CNF hemostatic gauze, highlighting its potential as a promising approach in the field of hemostatic control.

Wound microenvironment-responsive dually cross-linked nanofibrillar peptide hydrogels for efficient hemostatic control and multi-faceted wound management

The wound microenvironment-responsive hydrogel, featuring a dually cross-linked architecture, offers distinct advantages in the realm of drug delivery due to its exceptional mechanical properties and responsiveness to stimuli. In this investigation, a versatile dually cross-linked hydrogel was synthesized. The initial framework was established through non-covalent interactions employing a self-assembling peptide indomethacin-Gly-Phe-Phe-Tyr-Gly-Arg-Gly-Asp (abbreviated as IDM-1), while the second framework underwent chemical cross-linking of chitosan (CS) mediated by genipin. This dually-network arrangement significantly bolstered the structure, proving effective for hemostatic control. In addition, hydrogels can be triggered for degradation by proteases highly expressed in the wound microenvironment, releasing drugs like indomethacin (IDM) and CS. This characteristic introduced efficient multi-faceted wound management in vitro and in vivo, such as anti-inflammatory and antibacterial activities, ultimately augmenting the wound healing process. Thus, the development of a dually cross-linked hydrogel that enables smart drug release triggered by specific wound microenvironment presents considerable potential within the realm of wound management.

Acute epistaxis management by hemostatic agents a systematic review

Background: When compared to nasal packing, the data shows that hemostatic medications are more successful in controlling acute epistaxis. A comprehensive analysis was conducted to assess the effectiveness of topical hemostats in the treatment of epistaxis. Method: Four databases were searched thoroughly for literature. Only admissible observational studies were included. Information retrieved from eight studies included the following: country, rate of short-term and 30-day hemostatic control, patient-reported outcome measures, adverse events, sample size, intervention, treating method, and length of stay in hospital. Results: Eight papers were included in the review when it reached the second stage and satisfied the qualifying requirements. A total of 268 individuals were involved in three cohort and five case series investigations; 232 of them received absorbable intranasal medications. Two investigations on oxidized cellulose compounds and 5 studies on agents that promote the common coagulation pathway were presented. While oxidized regenerated cellulose was inserted endoscopically on the bleeding site in one trial and sutured to the nasal septum in another study, the earlier medicines were applied intranasally. Successful short-term hemostasis was attained in 80% to 100% of patients in 7 out of 8 trials. Patients treated with oxidized regenerated cellulose had considerably lower pain scores than those treated with nasal packing. There were no negative effects linked to the use of intranasal agents in any of the investigations. Conclusion: When compared to nasal packing, the data shows that hemostatic medications are more successful in controlling acute epistaxis.

Low Rebleed Incidence with Eptacog Beta Treatment through 24 and 48 Hours in Children (

Introduction Persons with hemophilia A or B and inhibitors (PwHABI) who are not on prophylaxis may have high rates of bleeding, and, if not treated effectively, may have significant morbidity related to rebleeding. Dosing strategies of bypassing agents (BPAs) are variable in clinical practice, and following a period of initial bleed control, rebleeding may occur. The development of additional bypassing agents that can minimize the incidence of rebleeding in this patient population is an important medical need. Eptacog beta is a recombinant activated human factor VII approved in the US and Mexico (Sevenfact®, 2020), as well as the EU and UK (Cevenfacta®, 2022) as a BPA for the treatment of bleeding episodes (BEs) in PwHABI aged 12 years and older using two initial dose regimens (IDRs) of 75 or 225 µg/kg. In the EU and UK, eptacog beta is also indicated for preventing bleeding in the setting of surgery and other invasive procedures. Approval in the US and Mexico was based on demonstrated efficacy in the pivotal phase 3 PERSEPT 1 trial (NCT02020369), which included 27 adolescent and adult PwHABI who treated 465 mild or moderate BEs. Bleed resolution at 24 hours post-initial infusion was 96.7% and 99.5% for 75 and 225 µg/kg IDRs, respectively, with a single bleed recurrence observed before 24 hours. The subsequent phase 3 PERSEPT 2 trial (NCT02448680) enrolled 25 PwHABI &amp;lt;12 years of age who treated 546 mild or moderate BEs. Bleed resolution at 24 hours post-initial infusion in these pediatric patients was 97.4% and 98.0% for 75 and 225 µg/kg IDRs, respectively. The objective of this analysis is to evaluate the incidence of rebleeding when treating mild or moderate BEs in PwHABI &amp;lt;12 years of age with eptacog beta during PERSEPT 2 at 24 and 48 hours post-initial dose. Methods PwHABI in PERSEPT 2 were randomized to either the 75 or the 225 µg/kg IDR to treat BEs and were crossed over to the alternate IDR every 3 months. No subjects in PERSEPT 2 were using prophylaxis. Subjects assigned to the 75 µg/kg IDR treated BEs with initial doses of 75 µg/kg eptacog beta followed by 75 µg/kg q3h as needed. Subjects assigned to the 225 µg/kg IDR treated BEs with an initial 225 µg/kg eptacog beta dose, followed after 9 hours by 75 µg/kg q3h as needed. Mild or moderate BE treatment success at a given time point was assessed by the patient or caregiver and was defined as obtaining a hemostasis evaluation of “excellent” or “good” on a 4-point scale with no additional eptacog beta being infused, no alternative hemostatic agents or blood products being used, and no increase in pain following the first “excellent” or “good” assessment. For this analysis, a BE was considered a rebleed if occurring at the same anatomical location as the original bleed, and within 24 or 48 hours of the initial infusion for the original bleed. Results During the study, subjects treated 546 BEs. Nine rebleeds occurred among 4 of the 25 children within 24 hours, and 13 rebleeds occurred among 6 children within 48 hours. The rebleed incidence and 95% confidence intervals (CIs) through 24 hours was 1.3% [95% CI: 0.0%, 3.6%] for the 75 µg/kg IDR and 2.0% [95% CI: 0.0%, 3.9%] for the 225 µg/kg IDR. The corresponding rebleed incidence and 95% CIs through 48 hours for the 75 and 225 µg/kg IDRs were 2.1% [95% CI: 0.0%, 4.5%] and 2.6% [95% CI: 0.4%, 4.9%], respectively. The differences in rebleed incidence between the two IDRs were not statistically significant at either 24 or 48 hours (Figure 1). The overall rebleed incidence in PERSEPT 2 was 1.6% [95% CI: 0.0%, 3.7%] through 24 hours and 2.4% [95% CI: 0.2%, 4.5%] through 48 hours. No treatment-related adverse events or thrombotic complications were observed. Conclusions Eptacog beta demonstrated a low overall incidence of rebleeding through 24 hours (1.6%) and 48 hours (2.4%) in PwHABI &amp;lt;12 years of age during PERSEPT 2. Rebleeding was similarly low for either IDR at both time points. These findings align with those previously reported for PERSEPT 1 in adolescent and adult patients. Combined with the high efficacy at 24 hours (&amp;gt;96%) observed in both trials and both IDRs, these results suggest that eptacog beta can provide clinicians and caregivers with a treatment option that can establish and maintain hemostatic control of mild or moderate BEs in PwHABI of all ages.