Topical Hemostatic Agents Research Articles

The role of Glubran 2 as biliostatic agent in liver resection

Background: Two of the most important sugical complications after liver resection are the development of biloma, an encapsulated collection of bile outside the biliary tree supported by a predominantly iatrogenic biliary fistula, and bile likeage. The development of biliary complications increases postoperative mortality, so the use of topical hemostatic agents have been recommended. Nonetheless, in Literature, only few study focused attention on the use of these agents to prevent complication related to liver resection

Prevention and management of difficult hemostasis in acute type A aortic dissection repair.

Postoperative bleeding after surgery for acute aortic dissection is one of the most common complications and has an important influence on mortality and morbidity. Therefore, various methods have been introduced to prevent or manage postoperative bleeding. In this article, we investigated the causes of bleeding after surgery for acute aortic dissection, and introduce appropriate transfusion or pharmacologic treatment, topical hemostatic agents, and local compressive maneuver to manage it.

Effect of hyperthermic chemotherapy on topical hemostatic agents

Purpose There is no clear consensus as to which topical hemostatic agent is best used during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy. The aim of this study was to evaluate the effect of hyperthermic chemotherapy on the biomechanical properties of organic topical hemostatic agents and histologically fibrin formation rates. Methods Four topical hemostatic agents (Spongostan™, Surgicel®, Fibrillar™, Arista®) were evaluated. All agents were mixed with 3 ml blood in sterile tubes separately to form clot formation. The resulting clot formations were incubated with 36 °C and 42 °C with saline or cisplatin for 1 h. Strength and flexibility of hemostatic samples were evaluated under weight of 0 g, 50 g, 100 g, 200 g and 300 g. All samples were stained with hemotoxylin-eosin and compared histologically for fibrin clot formation under light microscope. Results There were no statistically significant differences according to strength and flexibility of topical hemostatic agents on hyperthermic chemotherapy. Histopathologically, the highest fibrin formation was observed in Surgicel®, followed by Fibrillar™. The least fibrin formation was detected in Arista®. Conclusions This study demonstrated that exposure to hyperthermic chemotherapy did not significantly affect the biomechanical properties of organic topical hemostatic agents and the fibrin clot formation.

Use of liquid topical hemostatic agents in bleeding from the veins of the esophagus

Use of liquid topical hemostatic agents in bleeding from the veins of the esophagus

Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery.

Background and Objectives:This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic surgery.Methods:Utilization rates for oxidized regenerated cellulose powder (ORC), polysaccharide powder (PSP), and fibrin sealant solution (FSS) were obtained from hospitals via the Premier Healthcare databases for all surgical procedures from January 1, 2018 to September 30, 2020. All reported cases were extracted from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for ORC and PSP and from the FDA Adverse Event Reporting System (FAERS) database for FSS. Distributions of AEs by anatomical site (MAUDE/FAERS) and surgical procedures by specialty (Premier) were evaluated for each product. Number of cases and number and types of AEs were compared to the total utilization for each product.Results:PSP was the most used product during the period analyzed (n = 126,509 uses), followed by FSS (n = 80,628 uses), and ORC (n = 41,583 uses). Distribution of surgical procedures by anatomical site varied significantly between hemostatic agents (p < 0.001). ORC was associated with more patient cases with AEs and numbers of reported AEs compared with PSP and FSS (p < 0.001). ORC was associated with higher number of infections than PSP (p < 0.001) and FSS (p < 0.001).Conclusion:These findings suggest that ORC use in abdominal and pelvic surgery may result in more postoperative complications compared with non-ORC hemostatic agents. Further prospective randomized studies are needed to compare efficacy and safety of these products.

Hemostatic effects of traditional Inula viscosa and Capsella bursa-pastoris plant mixture extract on rat liver parenchymal bleeding model.

Failure to achieve effective bleeding control and problems related to transfusion in liver surgery are the most common causes of post-operative mortality and morbidity. Various methods/drugs including topical hemostatic agents have been em-ployed for bleeding control in liver surgery. This study was aimed to investigate the hemostatic properties of the herb mixture extract of Inula viscosa and Capsella bursa-pastoris (IvCbp) in rat liver laceration model, which have been traditionally used as antiseptic and hemostatic agents public in Hatay/Tukey. Thirty rats were divided into three groups equally and blood samples were taken from all rats for preoperative hemoglobin (Hb) measurements. Then, the standard liver resection model was applied to all rats. Sponge for the first rat group, Ankaferd Blood Stopper® Trend-Tech for the second rat group and IvCbp plant extract mixture for the third group were applied to resection areas for 3 minutes. Liver samples of all rats were evaluated in terms of inflammation and necrosis intensity on the 5th post-operative day. Post-operative Hb values were found as 11.0±1.1 g/dL in the sponge group, 11.9±2.0 g/dL in the Ankaferd group, and 14.1±1.2 g/dL in the IvCbp herb mixture group (p<0.001). In the histopathological examination, less necrosis was observed in the herb mixture group compared to the sponge and Ankaferd groups (p=0.001). In addition, no statistically significant necrosis difference was observed between sponge and Ankaferd groups. While less inflammation was observed in the herb mixture group compared to the other groups, Ankaferd group had the highest inflammation score (p<0.001). IvCbp herb mixture extract group provide effective hemostatic control, caused less Hb decrease and resulted in less inflammation and necrosis compared to Ankaferd and sponge groups in a rat liver resection model.

Post-cesarean ileus: An assessment of incidence, risk factors and outcomes

ObjectiveTo estimate the frequency of post cesarean paralytic ileus and to identify associated risk factors and outcomes. Study designA retrospective cohort study of woman who underwent cesarean delivery between 2005 and 2019. All parturients who had cesarean delivery were stratified and compared according to whether or not they were diagnosed with a paralytic ileus. Women were excluded if they had an intestinal injury or repair during the cesarean or if they suffered from a post cesarean mechanical bowel obstruction diagnosed during re-laparotomy. Basic demographics, obstetric history, current delivery characteristics, re-suturing indications and outcomes were obtained and analyzed. Univariate analyses were followed by a multivariate analysis (adjusted Odds Ratio (aORs) ; [95% Confidence Interval]). ResultsA total of 23,486 women met the inclusion and exclusion criteria of which 135 (0.6%) were diagnosed with paralytic ileus whilst 23,347 (99.4%) did not and served as the control group. Multivariate analysis revealed that an estimated intra-operative blood loss ≥ 1000 ml was the most significant risk factor for post cesarean paralytic ileus (aOR 2.27 (1.18–4.36)), followed by multifetal gestation (aOR 2.08 (1.24–3.51)), corporeal uterine incision (aOR 1.97 (1.07–3.63)), use of topical hemostatic agents (aOR 1.78 (1.19–2.66)) and increasing maternal age (aOR 1.78 (1.19–2.66)). Regarding maternal outcomes, post cesarean paralytic ileus was associated with higher rates of postpartum hemorrhage (44.4% vs. 13.4%, p < 0.01), transfusion of blood products (23.7% vs. 3.9%, p < 0.01), post-cesarean exploratory laparotomy (4.4% vs. 0.1%, p < 0.01) and prolonged hospital stay (32.6% vs. 5.2%, p < 0.01). ConclusionIn our population, whilst post cesarean paralytic ileus is infrequent, when it occurs it is associated with increased short-term maternal morbidity.

Optically Anisotropic Topical Hemostatic Coacervate for Naked‐Eye Identification of Blood Coagulation

AbstractBleeding control is critical for improving survival rates in clinical and military environments. Despite considerable efforts to develop hemostatic agents useful in open surgery, there has been little focus on effective topical hemostatic formulations capable of clearly identifying internal hemostasis and/or rehemorrhage processes without any optical labeling, particularly in minimally invasive endoscopic interventions. Herein, an optically anisotropic topical hemostatic agent for naked‐eye clarification of bleeding is reported. Hemostatic agents are formed via nonionic self‐coacervation between tannic acid, which is an adhesive polyphenol widely found in plants, and cholesteryl liquid crystals. Applying the hemostatic coacervates onto the injury site enables the visualization of the hemostasis process through immediate formation of a “polyphenol‐blood barrier,” followed by green‐colored light emission of the liquid crystal delaminated from the coacervates. Thus, such optically active hemostatic materials may help manage and prevent complications associated with internal hemorrhage in limited clinical settings.

Rescue fibrin glue-infiltrating hemostasis combined with hepatorrhaphy to control intractable postoperative bleeding from the liver cut surface.

Various topical hemostatic agents can help induce coagulation at the liver cut surface. However, hemostasis is usually ineffective in controlling bleeding. We present a case of rescue fibrin glue-infiltrating hemostasis combined with hepatorrhaphy to manage intractable postoperative bleeding from the liver cut surface. The case was a 56-year-old male patient with hepatocellular carcinoma in hepatitis B virus-associated cirrhotic liver. The patient was administered warfarin because of graft replacement of the ascending aorta and hemi-arch one year earlier. After warfarin was discontinued, segment VII partial hepatectomy was performed according to standard procedures. However, considerable bleeding occurred during and after hepatectomy. Bleeding from the liver cut surface was controlled over one hour using surface coagulation and topical application of four kinds of hemostatic agents. However, active abdominal bleeding led to reoperation soon after the hepatectomy. During the reoperation, we identified diffuse oozing from the edge of the liver cut surface which was difficult to control. Thus, we performed direct parenchymal injection of fibrin glue at the bleeding points using 12 fibrin glue kits which induced complete hemostasis. Because the patient would undergo anticoagulation again soon after the operation, we also performed hepatorrhaphy. The patient recovered uneventfully after the reoperation. He has been doing well for six months without complications. In conclusion, fibrin glue-infiltrating hemostasis effectively controlled intractable bleeding from the hepatic cut surface in our case. Thus, it can be considered as an optional method for rescue hemostasis.

Absorbable Hemostatic Particles to Reduce the Damage on the Follicular Reserve After Ovarian Endometriomas Stripping

Objective: to reduce the surgical damage to the ovarian reserve, after stripping of ovarian endometrioma, of the necrotic type given by the electrohaemostasis or ischemic type given by the suture. Design: perform haemostasis on ovarian parenchyma with topical haemostatic agents. Materials and methods: we used Arista AH which is a powder made up of microporous polysaccharide hemospheres that act by osmotic action and accelerate the natural coagulation process. We used Arista AH in 27 women with mono- or bilateral ovarian endometriosis. Results: in all treated cases we obtained a rapid and optimal haemostasis. There were no post-surgical complications related to haemostatic defects. Three months after the surgery, we checked the Antral Follicle Count (AFC) with a trans-vaginal ultrasound probe. AFC in 24 women with full follow-up gave the following results: unilateral endometrioma – AFC between 5 and 8 (MV: 6.3), bilateral endometriomas – the AFC between 5 and 7 (MV: 5.8). Conclusions: The use of Arista AH powder allows highly effective hemostasis and is easy to use, fully respecting the residual ovarian parenchyma after stripping.

Topical hemostatic agents in neurosurgery, a comprehensive review: 15years update.

Hemostasis in neurosurgery is of utmost importance. Bleeding management is one of the crucial steps of each neurosurgical procedure. Several strategies, namely thermal, mechanical, electric, and chemical, have been advocated to face blood loss within the surgical field. Over time, countless hemostatic agents and devices have been proposed. Furthermore, the ever-growing recent technological innovation has made available several novel and interesting tools. Pursuant to their impact on surgical practice, we perceived the imperative to update our previous disclosure paper. Therefore, we reviewed the literature and analyzed technical data sheets of each product in order to provide an updated and comprehensive overview in regard to chemical properties, mechanisms of action, use, complications, tricks, and pitfalls of topical hemostatic agents.

Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Topical hemostatic agents have become essential tools to aid in preventing excessive bleeding in surgical or emergency settings and to mitigate the associated risks of serious complications. In the present study, we compared the hemostatic efficacy of SURGIFLO® Hemostatic Matrix Kit with Thrombin (Surgiflo—flowable gelatin matrix plus human thrombin) to HEMOBLAST™ Bellows Hemostatic Agent (Hemoblast—a combination product consisting of collagen, chondroitin sulfate, and human thrombin). Surgiflo and Hemoblast were randomly tested in experimentally induced bleeding lesions on the spleens of four pigs. Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 min. Secondary endpoints included the number of product applications and the percent of product needed from each device to achieve hemostasis. Surgiflo demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast. Surgiflo-treated lesion sites achieved hemostasis in 77.4% of cases following a single product application vs. 3.3% of Hemoblast-treated sites. On average, Surgiflo-treated sites required 63% less product applications than Hemoblast-treated sites (1.26 ± 0.0.51 vs. 3.37 ± 1.16). Surgiflo provided more effective and faster hemostasis than Hemoblast. Since both products contain thrombin to activate endogenous fibrinogen and accelerate clot formation, the superior hemostatic efficacy of Surgiflo in the porcine spleen punch biopsy model seems to be due to Surgiflo’s property as a malleable barrier able to adjust to defect topography and to provide an environment for platelets to adhere and aggregate. Surgiflo combines a flowable gelatin matrix and a delivery system well-suited for precise application to bleeding sites where other methods of hemostasis may be impractical or ineffective.

Thrombin Embedded in eMPs@Thr/Sponge with Enhanced Procoagulant Ability for Uncompressible and Massive Hemorrhage Control.

Uncontrollable hemorrhage, especially uncompressible and massive hemorrhage, is life threatening. To develop a kind of hemostatic material that is biocompatible and has effective hemostatic performance, a starch-polyethylene glycol sponge (St-PEG sponge) incorporated with electrospraying microspheres made from carboxymethyl chitosan and sodium alginate (CMC/SA eMPs) is employed to fabricate the topical hemostatic agent for application. To load thrombin safely and effectively, CMC/SA eMPs encapsulating thrombin compounds (eMPs@Thr) are further incorporated with St-PEG sponge to obtain eMPs@Thr/sponge. The results show that eMPs@Thr/sponge could obviously reduce blood loss and shorten the hemostatis time compared with commercial hemostatic products Kuai Kang. The construction of the eMPs@Thr/sponge could not only maintain the expandable properties of the St-PEG sponge but also strengthen the procoagulant activity. Therefore, this work provides a facile approach for loading thrombin given the fact that thrombin suffers from instability and risk of thrombus. It is predicted that eMPs@Thr/sponge might hold great potential in uncompressible and massive hemorrhage control.

PEG-coated patch parenchymal closure technique and initial outcomes during minimally invasive partial nephrectomy.

The Hemopatch® is a novel polyethylene glycol-coated (PEG-coated) collagen patch that acts as a topical hemostatic agent. It has been applied to a variety of surgical techniques. Here, we present our series and technique using a PEG-coated patch for minimally invasive partial nephrectomy (MIPN). We conducted a retrospective chart review of all patients undergoing MIPN by a single surgeon at a tertiary Canadian medical center between July and December 2018. We included patients if a PEG-coated patch was used to close the renal parenchymal defect. We also describe in detail our technique for laparoscopic patch deployment. A total of 17 patients met inclusion criteria, of whom 12 were male. Mean age was 63 years old. Median size of renal mass was 2.85 cm in largest dimension and median RENAL score was 6. Hilar clamping was carried out in 12 (70.9%) cases, with an average warm ischemic time of 16.1 minutes. The remainder of cases were performed off-clamp. Median estimated blood loss was 238 mL and the mean change in hemoglobin on postoperative day 1 compared to preoperatively was 21.2 g/L. The average length of stay was 1.76 days. No patient required blood transfusion or underwent angioembolization or re-operation for bleeding within 90 days. There were no Clavien-Dindo grade 3 or greater complications. A PEG-coated patch can be used safely and effectively in lieu of traditional two-layer renorrhaphy with acceptable outcomes. Larger, prospective series are required to ascertain its true value and cost-effectiveness.

Systematic studies on blood coagulation mechanisms of halloysite nanotubes-coated PET dressing as superior topical hemostatic agent

Halloysite nanotubes (HNTs), a traditional mineral Chinese medicine, have been used to stop bleeding for thousands of years. However, the coagulation mechanisms of HNTs and their practical application potential have not been fully elucidated. In this study, HNTs were found to accelerate hemostasis via multiple dependent approaches: (i) absorbing water and concentrating blood due to their super-hydrophilicity and unique tubular nanostructure; (ii) triggering an intrinsic coagulation cascade by negatively charged surface interaction; and (iii) accelerating clot formation by activating and linking with platelets. To solve the difficulty in the application of powder, a HNT-coated polyester fiber dressing was designed by an impregnation method. The HNT coating enables the dressing to resist massive hemorrhaging of the liver and vessels, as well as epidermal bleeding. Moreover, the HNT-coated fiber dressings are not accompanied by burning or adhesion at the wound sites. In summary, this work provides profound insight into HNT hemostasis through the physical and biological interactions between HNTs and blood, which represents a promising strategy for effective prehospital treatment and civilian needs.

Management of life-threatening hemoptysis in the ICU.

Life-threatening hemoptysis is commonly encountered in the ICU and its management can be challenging even for experienced clinicians. Depending on the etiology and severity, one can tailor the treatment modality and therapeutic intervention(s). The grading of severity of hemoptysis varies greatly in the literature; however, unlike hemorrhage in other scenarios, small amounts of blood can significantly impair oxygenation and ventilation leading to cardiovascular collapse. Importantly, the initial evaluation and management should focus on airway and hemodynamic stabilization along with maintenance of oxygenation and ventilation. In this review, we discuss commonly encountered etiologies, vascular anatomy, diagnostic evaluation, and therapeutic interventions. We examine the evolving trends in etiologies of life-threating hemoptysis over the years. The role of flexible and rigid bronchoscopy as both a diagnostic and therapeutic modality is explored, as well as the use and indications of several bronchoscopic techniques, such as topical hemostatic agents, endobronchial tamponade, and tranexamic acid (TXA). In addition, we assess the use of multi-row detector computed tomography as the initial rapid diagnostic method of choice and its use in planning for definitive treatment. The efficacy and long-term results of bronchial artery embolization (BAE) are evaluated, as well as indications for surgical intervention. Furthermore, the importance of a multidisciplinary approach is emphasized. The necessary interplay between intensivists, consultative services, and radiologists is described in detail and an algorithmic management strategy incorporating the above is outlined. Given the complexity in management of life-threatening hemoptysis, this paper aims to summarize the available diagnostic and therapeutic methods and provide a standardized approach for the management of patients with this often difficult to treat condition.

An international multidisciplinary peer-driven consensus on the optimal use of hemostatic powders in surgical practice.

Bleeding is a consequence of insufficient hemostasis and excessive bleeding at a surgical site is associated with an increased risk of post-operative infection, transfusion and re-operation, in addition to increased hospital length of stay and costs. Surgeons employ a range of methods to achieve hemostasis, including topical hemostatic agents of differing composition and properties. Hemostatic powders are a sub-group of topical hemostats, which can be used in helping as adjuncts to manage troublesome bleeding in a variety of situations. As this technology is relatively new and potentially not well known by the broad surgical community, no specific guidelines or recommendations for the optimal use of hemostatic powders in surgery currently exist. A steering group throughout Europe of multidisciplinary surgeons, expert in hemostasis and hemostatics, identified from literature and from personal experience, five key topics. When to use hemostatic powder, the evidence for use, benefits of use, safety remarks and considerations in various surgical specialties. Thirty-seven statements were subsequently drawn from these five key topics. An online survey was sent to 128 high-volume surgeons working in breast surgery, gynaecological and obstetric surgery, general and emergency surgery, thoracic surgery and urological surgery in Europe to assess agreement (consensus) with these statements. Consensus was defined as high if ≥ 75% and very high if ≥ 90% of respondents agreed with a statement. A total of 79 responses were received and consensus among the surgical experts was very high in 27 (73%) statements, high in 8 (22%) statements and was not achieved in 2 (5%) statements. Based on the consensus scores, the steering group produced 16 key recommendations which they considered could improve patient outcomes by reducing post-operative bleeding and its associated complications using hemostatic powder.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13304-021-01136-x.

Tranexamic acid-loaded hemostatic nanoclay microsphere frameworks.

Fast acting topical hemostatic agents play a key role in hemorrhage control. Retarding fibrinolysis is also critical in improving coagulation, thereby expanding chances of survival. The purpose of the present work was to investigate the physical properties, loading capacity and hemostatic efficacy of newly developed nanoclay microsphere frameworks (NMFs) loaded with tranexamic acid (TA), as antifibrinolytic agent. Nanoclay compositions were prepared with increasing levels of TA. Results showed that TA was successfully incorporated into the nanoclay structure and released when solvated with ethanol. Both doped and undoped NMFs significantly decreased activated partial thromboplastin time and increased clot stiffness, which was attributed to significantly thinner fibrin fibers and a denser clot structure.

Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial

When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA). We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups. The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of-13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.

The Effect of Zinc Oxide Scallop-Shell Powder and Complications After Coronary Angiography

Introduction: Coronary angiography is often associated with complications such as hemorrhage and hematoma that should be considered and be minimized. Objective: This study aimed to determine the effect of Zinc oxide scallop-shell powder as a topical hemostatic agent (composed mainly of calcium) on complications after coronary angiography. These complications include hemostasis time, low back pain, hemorrhage, hematoma, the necessity of sandbags, and patient ambulation. Materials and Methods: The current research was a blind, parallel, randomized clinical trial done on 150 patients under coronary angiography. They were randomly divided into three equal groups of A (control), B (case 1), and C (case 2). In group A, hemostasis was done with manual compression, use of ChitoHem powder, putting sandbag for 4-6 h in a supine position, and getting out of bed after 24 h. In group B, instead of ChitoHem powder, we used Zinc oxide scallop-shell powder. In group C, hemostasis was done with manual compression, Zinc oxide scallop-shell powder, putting sandbag for 1 h in a supine position, and getting out of bed after 2 h. The duration of hemostasis, bleeding, and hematoma after hemostasis and the severity of low back pain were investigated at 8 point intervals during 24 h. Data analysis was done using descriptive statistics indicators and Kolmogorov-Smirnov, ANOVA, Chi Square, Fisher exact test and Kruskal-Wallis tests. Results: The mean ±SD ages of groups of A, B, and C were 60.08 ±11.32, 60.22 ±10.30, and 61.69 (10.61), respectively, which was not statistically different. Furthermore, there was no significant difference between these three groups regarding their demographic information. There were statistically significant differences between groups about the amount of low back pain at the second, third, and fourth hours after angiography (P= 0.001). There was a significant difference in the amount of bleeding between the three groups (P=0.017). The difference in time of hemostasis in the three groups was not statistically significant. Conclusion: The Zinc oxide scallop-shell powder reduces catheter site bleeding after coronary angiography and bed rest time and ultimately the severity of low back pain. Performing a similar study is recommended.