Use Of Hemostatic Agents Research Articles

Bleeding from lumbar ventral epidural venous plexus managed with hemostatic agent from oxidized non-regenerated cellulose

Bleeding from epidural blood vessels may be an unpleasant complication during surgery of the lumbar spine, which is often difficult to manage with electrocoagulation. The use of local hemostatic agents is apossible solution. This paper presents the first experience with an agent of oxidized non-regenerated cellulose. The agent of oxidized non-regenerated cellulose was used in 21 patients (12 women and 9 men) to stop bleeding from the ventral epidural lumbar venous plexus. It was always removed before the end of the operation. In all cases, bleeding was stopped within 2 minutes. Bleeding did not recur until the end of surgery (even after removal of the agent). No early or other complications were observed in the patients studied. The agent of oxidized non-regenerated cellulose appears to be arational and effective solution for bleeding from epidural veins in the lumbar spine.

Anticoagulation Use prior to Common Dental Procedures: A Systematic Review

Currently, the number of patients on oral anticoagulation is increasing. There is a paucity of data regarding maintaining oral anticoagulation (especially novel oral anticoagulants) around the time of specific dental procedures. A dentist has three options: either to stop anticoagulation, to continue it, or to bridge with heparin. A systematic review of 10 clinical trials was conducted to address this issue. It was found that continuing anticoagulation during dental procedures did not increase the risk of bleeding in most trials. Although none of the studies reported a thromboembolic event after interruption of anticoagulation, the follow-up periods were short and inconsistent, and the heightened thromboembolic risk when stopping anticoagulation is well known in the literature. Heparin bridging was associated with an increased bleeding incidence. We recommend maintaining oral anticoagulation with vitamin K antagonists and novel oral anticoagulants for the vast majority of dental procedures along with the use of local hemostatic agents.

The Impact on Ovarian Reserve of Different Hemostasis Methods in Laparoscopic Cystectomy: A Systematic Review and Meta-analysis.

The objective of this review was to analyze the impact on ovarian reserve of the different hemostatic methods used during laparoscopic cystectomy. The studies were identified by searching electronic databases (MEDLINE, Embase, Cochrane, LILACS) and scanning reference lists of articles. We selected clinical trials that assessed the influence of hemostatic techniques on ovarian reserve in patients with ovarian cysts with benign sonographic appearance submitted to laparoscopic cystectomy by stripping technique. The included trials compared different laparoscopic hemostatic techniques: suture, bipolar electrocoagulation, ultrasonic energy and hemostatic sealants. The outcomes evaluated were level of serum anti-Mullerian hormone (AMH) and antral follicle count (AFC). The possibility of publication bias was evaluated by funnel plots. Twelve trials involving 1,047 patients were evaluated. Laparoscopic suture was superior to bipolar coagulation when evaluating serum AMH and AFC, in the 1st, 3rd, 6th and 12th month after surgery. In the comparison between bipolar and hemostatic sealants, the results favored the use of hemostatic agents. The use of ultrasonic energy was not superior to the use of bipolar energy. We recommend suture for hemostasis during laparoscopic cystectomy.

55 - The use of haemostatic agents in the setting of glans resurfacing and restoration for localized lesions of the penis

55 - The use of haemostatic agents in the setting of glans resurfacing and restoration for localized lesions of the penis

Drainless parotidectomy and the same day discharge with routine use of topical haemostatic agent and Balaclava bandage.

Drainless parotidectomy and the same day discharge with routine use of topical haemostatic agent and Balaclava bandage.

Imaging appearance on CT post laparoscopic Roux-en-Y gastric bypass using bioabsorbable prosthesis with fibrin glue fixation to prevent a Petersen's space hernia.

Imaging post bariatric surgery is becoming more common over the past decade due to increasing incidence of obesity in the population and subsequent treatment.In recent years, the use of topical haemostatic agents and bioabsorbable prostheses has increased leading to higher likelihood of encountering these agents on post-operative imaging. Imaging in the post-operative period is occasionally performed to assess for complications such as obstruction, leak and abscess formation. Familiarity with these agents is crucial in preventing incorrect diagnosis.Laparoscopic Roux-en-Y gastric bypass (RYGB) is favoured over the open approach as it is safer and more effective, with a mortality rate of 0.5% and morbidity around 7–14 %. The main cause of late post-RYGB complications is the development of internal hernias such as a Petersen’s hernia. During the procedure, a space between the alimentary loop of the small bowel and the transverse mesocolon is created and is called the Petersen’s defect. Subsequently, a part of the small bowel can herniate through this orifice. As this operation is becoming more common, the incidence of internal herniation has been increasing.This case report describes a new bariatric surgical technique and the associated post-operative radiological appearances on CT. The surgical technique has been pioneered in Sydney, Australia and involves a laparoscopic RYGB using bioabsorbable prosthesis with fibrin glue fixation to prevent a Petersen’s space hernia.

Magnetic resonance imaging characteristics and changes in hemostatic agents after partial nephrectomy

To evaluate the characteristics of images generated by magnetic resonance imaging (MRI) and changes in the mass-like lesion (MLL) during the follow-up of patients who underwent partial nephrectomy (PN) with the intra-operative use of hemostatic agents (HAs). The records of patients who had undergone PN in our clinic due to renal mass between January 2013 and August 2018 were retrospectively reviewed. Our study included 47 patients who were administered one or more HAs during the PN and who received diffusion and dynamic MRI at the post-operative 2nd/4th Queryand 12th month. MLL is defined as T2 heterogeneous, intermediate-signal intensity bolster-related mass with a pseudocapsule in the renal parenchymal defect. When we looked at the morphological changes of MLL, the mean largest axial dimensions of masses were 27.3 (range 12.2-44.7) mm in the first follow-up period (2nd/4th months) and 21.2 (range 11-44.7)mm in the 12th month follow-up period. The average change in size of MLL was - 0.66mm/month. We did not see any significant relationship between observation of MLL in the post-operative follow-up MRI images and the use of HAs such as Surgicel®, Spongostan®, and autologous fatty tissue as well as the amount of the agents used in PN operations (p = 0.405, p = 0.159, respectively). The distinction of MLL causing bolster-related mass and granulomatosis tissue from relapse/recurrence can be made based on the change in mass size observed in the MR images and image characteristics.

Patient’s blood management in obstetric practice with placenta accrete

Placenta accreta is one of the most severe anomalies of attachment, due to the high risk of massive bleeding. At present, the paradigm of organ-preserving delivery is laid. The implementation of this tactic is possible in the context of the introduction into the obstetric practice of patient blood management (PBM).Objective:to evaluate the effectiveness of blood preservation methods in the management and delivery of pregnant women with placenta placenta accrete.Materials and methods:The study group consisted of 59 pregnant women with placenta accreta in age from 20 to 40 years old (32,43 ± 5,05), who were examined in «Scientific Medical Research Center of Obstetrics”. Clinical, special (ultrasound and magnetic pelvic magnetic resonance imaging) and laboratory methods were used. A program of preparation for delivery was developed using the principles of the PBM: treating anemia at the preoperative stage; a multidisciplinary operating team was prepared (two obstetricians, a surgeon, anesthesiologist and resuscitator, anesthetist, transfusionist, physician, who provides work for Cell Saver, laboratory assistant). Operational tactics included a bottom cesarean section using one of the methods of surgical prevention and arrest of bleeding - bilateral ligation of the internal iliac arteries (1st group) (19 women), temporary stop of blood flow in common iliac artery by means of vascular clamps Satinsky (18 patients – 2ndgroup); bilateral overlay of turnstile harnesses on the base of the wide ligaments and the cervical-neck area, supplemented by a controlled balloon tamponade of the uterus (22 patients – 3rd d group). The operation was carried out under conditions of intraoperative reinfusion of autoerythrocytes on the apparatus “Cell-Saver 5”, donor FFP and erythrocyte component, tranexam preparations, rFVIIa (KoagilVII) were administered. In 80% of women, operations were performed under combined spinal-epidural anesthesia.Results:the lowest blood loss was detected in the 3rd group with compression complex hemostasis: 1286 ± 510 ml. Accordingly, the volumes of infusion and transfusion therapy were also the smallest in this group. The volume of reinfused autoerythrocytes ranged from 260 ml to 1420 ml and averaged 801,7 ± 414,18 ml with a hematocrit of 55-60%. Donor erythrocytes were transfused to only 27 patients in an average volume of 785,1 ± 134,2 ml. rFVIIa (Koagil) was administered to four patients: three from the first group and one from the second group: a significant decrease in the speed and volume of bleeding was noted, and he performed an organ-sparing operation. Hysterectomy was performed on five women (8,77%). In the postoperative period was carried out antianemic therapy. The hospital stay averaged 7,9 ± 1,8 days.Conclusion:The special role in the management and delivery of pregnant with placenta accreta plays the use of various PBM techniques , which include rational therapy of preoperative and postoperative anemia with modern iron preparations, rational surgical tactics, red blood cell autotransfusion, use of modern hemostatic agents and blood substitutes. A comprehensive multidisciplinary approach to this problem allows reducing blood loss, minimizing the volume of donor blood components and implementing organ-preserving tactics in a significant number of women.

Nanostructured fibrin agarose hydrogel as a novel haemostatic agent

Blood loss remains a major concern during surgery and can increase the morbidity of the intervention. The use of topical haemostatic agents to overcome this issue therefore becomes necessary. Fibrin sealants are promising haemostatic agents due to their capacity to promote coagulation, but their effectiveness and applicability need to be improved. We have compared the haemostatic efficacy of a novel nanostructured fibrin‐agarose hydrogel patch, with (c‐NFAH) or without cells (a‐NFAH), against two commercially available haemostatic agents in a rat model of hepatic resection. Hepatic resections were performed by making short or long incisions (mild or severe model, respectively), and haemostatic agents were applied to evaluate time to haemostasis, presence of haematoma, post‐operative adhesions to adjacent tissues, and inflammation factors. We found a significantly higher haemostatic success rate (time to haemostasis) with a‐NFAH than with other commercial haemostatic agents. Furthermore, other relevant outcomes investigated were also improved in the a‐NFAH group, including no presence of haematoma, lower adhesions, and lower grades of haemorrhage, inflammation, and necrosis in histological analysis. Overall, these findings identify a‐NFAH as a promising haemostatic agent in liver resection and likely in a range of surgical procedures.

Use of topical haemostatic agents in cardiovascular surgery

The problem of haemostasis in cardiovascular surgery is of current concern. Recent trends are towards increased use of topical haemostatic agents. Tachocomb has been used for more than 30 years in abdominal surgery and oncology. The purpose of the present publication is to analyse the literature data and formulate the indications for the use of Tachocomb in cardiovascular surgery. Multicenter randomized and local studies have demonstrated efficacy of Tachocomb in treatment of surgical haemorrhage in operations on the heart, thoracic aorta, carotid arteries and lower-limb arteries, resulting in significantly decreased time to achieve haemostasis, decreased volume of blood loss and haemotrasfusion, as well as reduced frequency of complications. Also shown was economic efficacy, including a shortened length of patients' hospital stay. This is followed by describing a wide spectrum of examples of alternative use of Tachocomb, including its use for seamless closure of defects of cardiac chamber walls, aero- and lymphostasis, prevention of formation of commissures. Convincing experimental and clinical results make it possible to formulate a series of indications for the use of Tachocomb in cardiovascular surgery.

Peri- and Postpartum Management of Patients With Factor XI Deficiency.

Factor XI (FXI) deficiency is an uncommon autosomal disorder with variable bleeding phenotype, making peripartum management challenging. We describe our experience in pregnant women with FXI deficiency and identify strategies to minimize the use of hemostatic agents and increase utilization of neuraxial anesthesia. Electronic records of 28 pregnant women with FXI deficiency seen by a hematology service in an academic medical center from January 2006 to August 2018 were reviewed. Data on bleeding, obstetric history, peripartum management, and FXI activity were collected. Partial FXI deficiency was defined as >20 IU/dL and severe <20 IU/dL. Median FXI activity was 42 IU/dL (range <1-73 IU/dL), and median activated partial thromboplastin time was 32.2 seconds (range: 27.8-75 seconds). There were 64 pregnancies: 53 (83%) live births and 11 (17%) pregnancy losses. Postpartum hemorrhage occurred in 9 (17%) pregnancies. Antifibrinolytic agents and fresh frozen plasma were used only in women with severe deficiency (42% with bleeding and 17% with no bleeding phenotype, respectively). Neuraxial anesthesia was successfully administered in 32 (59%) deliveries. Most women with FXI deficiency have uncomplicated pregnancies and deliveries with minimal hemostatic support. Neuraxial anesthesia can be safely administered in most women.

Experimental assessment of efficiency of new domestic local haemostatic means on the basis of chitosan

One of the main reasons for the death of potentially wounded military personnel on the battlefield is ongoing bleeding. In recent years, with the advent of a new group of local hemostatic drugs, the results of prehospital care with external massive bleeding have improved significantly. At the same time, local haemostatic agents based on chitosan showed the greatest effectiveness. The results of the experimental evaluation of the effectiveness of new local haemostatic agents based on chitosan: «Gemohit» (powder, 20 g in the package) and «Hemohit-bandage» (a bandage in the z-fold, 8×150 cm) using the model of external massive arterial bleeding in sheep according to the variant of marginal femoral artery injury. Some of the tests were carried out after 3 years of storage of the preparations (3 samples) and under ambient conditions minus45°C (2 tests). It was found that with external massive arterial bleeding, the use of powder and bandage in the z-fold ensured survival of the animals in 100% of cases, primary and final hemostasis was achieved in 50 and 100% of cases, respectively. Storage for 3 years, as well as use of the drug at low ambient temperature does not reduce its effectiveness. The use of local haemostatic agents «Gemohit» and «Hemohit-bandage» is not accompanied by side effects (local hyperthermal reaction, distal or proximal embolism of blood vessels). Local haemostatic funds «Gemohit» and «Gemohit-bint» showed high efficiency in the experimental model of massive external arterial bleeding. Using the local hemostatic agent «Gemohit» in the form of a bandage is more promising in terms of convenience and effectiveness than the use of powder.

Efficacy and Safety of Prothrombin Complex Concentrate (PCC) for Direct Oral Anticoagulant Reversal: A Single Institutional Experience

BackgroundAn increasing number of patients (pts) requiring anticoagulation are treated with oral factor Xa inhibitors (DOAC) as an alternative to vitamin K antagonists. Prior to the recent approval of coagulation factor Xa (recombinant), inactivated-zhzo in May 2018, four factor prothrombin complex concentrates (4PCC) have been used to reverse the effects of DOACs. We retrospectively analyzed our institutional experience with 4 PCC for reversal of apixaban and rivaroxaban to determine the indications for 4PCC use and outcomes.MethodsAfter IRB approval, pts receiving 4PCC, from Feb 2016 to January 2018 were identified from our pharmacy database and pts receiving PCC for reversal of apixiban and rivaroxaban were selected. Consenting pts medical records (MR) were reviewed for demographics and indications for DOAC and 4PCC as well as outcomes of 4PCC use. Pts were excluded if they had discontinued DOAC greater than 7 days before receiving 4PCC or if they were started on alternative forms of anticoagulation at a therapeutic dose prior to receiving PCC.Primary endpoint was clinical efficacy (clinical improvement or stability) or ability to undergo required procedure) and secondary endpoint was safety (thromboembolism and death) up to 35 days post-infusion of 4PCC. Stability for intracranial hemorrhages (ICH) was determined by clinical improvement and if head imaging performed, no change in head CT or MRI scan, whereas stability for other bleeds was determined by hemoglobin stability and opinions of providers in the MR. Primary efficacy outcome for pts undergoing surgery was based on MR comments by the performing surgeon and use of other hemostatic agents and red blood cell transfusions.Results49 (32 male) pts, median age of 74 (31-95) years, met our study criteria and received 4PCC for reversal of apixaban (n=29) and rivaroxaban (n=20). Indications for anticoagulation were atrial fibrillation (n=35) and thrombosis (n=14). Of the 14 pts with thrombosis, 11 had deep vein thrombosis while 3 had thrombosis at other sites (arterial graft thrombus, aortic thrombus, and portal vein thrombosis). 4PCC was administered in the emergency department (n=36), intensive care unit (n=10), or the general medical wards (n=3). Indications for 4PCC included bleeding (n=40), procedure/surgery (n=6), and hemodynamic instability with clinical suspicion for bleeding (n=3). Bleeding location is reported in table 1. All procedure/surgery performed for clinical symptoms not related to hemorrhage were non-elective procedures and included exploratory laparotomy (n=4), laparoscopic cholecystectomy (n=1), and incision and drainage of abdominal wall abscess (n=1). Median PCC dose was 42 (10.3-63.3) IU/kg.Outcomes32/40 (80%) pts had stability or an improvement in bleeding, while 5 pts had bleeding that did not improve. 3 pts, all with ICH, had a bleed that worsened 8 (6-8) hours after PCC but then spontaneously stabilized 24 (8-24) hours later. Of those presenting with clinical bleeding, 3 pts received FFP within 3 hours prior to treatment with 4PCC, 2 pts received FFP within 12 hours after 4PCC, and 2 pts received FFP within 3 hours before and 12 hours after 4PCC. Of 40 pts receiving PCC for bleeding, 14 also had a procedure to help achieve hemostasis (Table 2).All 6 pts were able to undergo procedure/surgery. 5/6 patients achieved adequate hemostasis. One pt had no mention of unanticipated bleeding in the MR but received 8 units of FFP intraoperatively after 4PCC.6/49 (12%) pts had a thrombotic complication within 35 days of receiving PCC (median 4 days; (range 1-31) including arterial graft thrombus (n=1), superficial venous thrombus (n=1), bilateral soleal vein thrombosis (n=1), internal jugular vein and innominate vein thrombosis (n=1) stroke (n=1), and progression of preexisting portal vein thrombosis (n=1). All-cause mortality was 20%. 3/10 deaths were in pts who never achieved neurologic recovery after ICH and one pt had stroke-like symptoms leading to death 30 days after 4PCC (administered for ICH).ConclusionIn this cohort, 80% of pts demonstrated clinical stability/improvement of hemorrhage. All pts were able to undergo surgical procedures; however 17% required additional FFP to achieve hemostasis. Thromboembolism occurred in 12% of patients. No deaths could definitely be attributed to 4PCC; however, 30% of deaths could be attributable to the underlying hemorrhagic episode. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Use of Topical Hemostatic Agents in Minimally Invasive Gynecologic Surgery: A Systematic Review

Objective: To evaluate hemostatic effectiveness and peri-operative outcomes when topical hemostatic agents (HA) are used in minimally invasive gynecologic surgeries (MIGS) for benign conditions.

Catastrophic haemorrhage in military major trauma patients: a retrospective database analysis of haemostatic agents used on the battlefield

ObjectivesCatastrophic haemorrhage is a leading cause of morbidity and mortality in trauma, in both military and civilian settings. There are numerous studies looking at the effectiveness of different haemostatic agents...

Network meta-analysis of topical haemostatic agents in thyroid surgery.

The objective of this study was to investigate the potential benefit of local haemostatic agents for the prevention of postoperative bleeding after thyroidectomy. A systematic literature search was performed, and RCTs involving adult patients who underwent thyroid surgery using either active (AHA) or passive (PHA) haemostatic agents were included in the review. The main outcome was the rate of cervical haematoma that required reoperation. A Bayesian random-effects model was used for network meta-analysis with minimally informative prior distributions. Thirteen RCTs were included. The rate of cervical haematoma requiring reoperation ranged from 0 to 9·1 per cent, and was not reduced by haemostatic agents: AHA versus control (odds ratio (OR) 1·53, 95 per cent credibility interval 0·21 to 10·77); PHA versus control (OR 2·74, 0·41 to 16·62) and AHA versus PHA (OR 1·77, 0·12 to 25·06). No difference was observed in the time required for drain removal, duration of hospital stay, and the rate of postoperative hypocalcaemia or recurrent nerve palsy. AHA led to a significantly lower total postoperative blood loss and reduced operating time in comparison with both the control and PHA groups. The general use of local haemostatic agents has not been shown to reduce the rate of clinically relevant bleeding.

Hemostatic agent use in thyroid surgery: a meta-analysis.

The use of hemostatic agents in thyroid surgery has been widely reported in the literature. The aim of this study is to assess the safety and efficacy of hemostatic agents in comparison to conventional techniques for hemostasis by meta-analysis of the current literature. Articles were identified from PubMed and EMBASE using the following keyword searches: "hemostatic agent and thyroid surgery" and "hemostatic agent and thyroidectomy". Outcomes included total operative time, estimated blood loss, length of hospital stay, and intraoperative and postoperative complications. Data were extracted following review of appropriate studies by two independent authors and outcome differences were calculated using analysis of variance and the Bonferroni method. Thirty-four publications were identified and 10 studies met our inclusion criteria, totaling 941 patients, 519 (55.1%) of which received a hemostatic agent during thyroid surgery. Of these patients who had hemostatic agents, 369 (71%) received a hemostatic gel and 150 (29%) received an oxidized cellulose patch. Outcome measures in each of these groups were compared with the patients receiving only conventional methods of hemostasis. The risk of hematoma formation in the hemostatic gel group was comparable to conventional hemostatic methods (95% CI: 0.33, 2.59). This was also true when comparing conventional hemostasis to the patch (95% CI: 0.64, 15.24). No difference in the risk for seroma formation was found between the conventional and hemostatic gel groups (95% CI: 0.26, 3.95). Drain output was significantly less in the gel group 40.75±35.6 mL compared to 66.26±31.2 mL in the conventional group (95% CI: -23.422, -7.460). Patients who received hemostatic agents had shorter hospital stays when compared to the conventional group (95% CI: -1.057, -0.203). Our meta-analysis suggests that the use of a hemostatic agent in thyroid surgery yields minimal advantages for the management of perioperative bleeding risk.

Off-label use of 4-factor prothrombin complex concentrate is common despite little known benefit: A retrospective study.

While four-factor prothrombin complex concentrate (4F-PCC) is FDA-approved for reversal of warfarin-induced major bleeding, its use in real-world settings is unclear. This study's objective was to identify indications leading to 4F-PCC use and associated outcomes at a single university hospital. This was a retrospective cohort study of patients receiving 4F-PCC over a 22-month period. A dose was "on-label" if given for reversal of warfarin-induced coagulopathy in patients with major bleeding or requiring urgent surgeries/procedures; other doses were "off-label". A total of 165 doses of 4F-PCC in 154 patients were given. Sixty-one percent of doses were on-label, while 39% were off-label. Intracranial hemorrhage was the most common indication (55% of doses). On-label patients had significantly higher rate of INR normalization and survival to hospital discharge than off-label patients. There was no difference in time to INR normalization, time to hemostasis, or incidence of thromboembolic complications. Off-label use of 4F-PCC is likely common, occurring in nearly 40% of drug administrations at our center. Larger-scale prospective trials studying specific indications are needed for validation in off-label settings. Until such evidence is available, given potential harms historically displayed by off-label use of other hemostatic agents, limiting off-label 4F-PCC use is recommended.

Floseal only versus in combination in spine surgery: a comparative, retrospective hospital database evaluation of clinical and healthcare resource outcomes

ABSTRACTObjective: Flowable agents such as Floseal® (F) are often reserved as adjuncts to non-flowable agents (i.e. gelatin (G) sponges and thrombin (T)) when bleeding is not sufficiently controlled. Based on their perceived positive impact, it is postulated that flowable agents alone may result in better clinical and resource utilization outcomes. Clinical and health-care utilization outcomes were compared in this retrospective analysis of spine surgery cases with charges for Floseal only (FO) and F + G/T.Methods: The United States Premier Hospital Database was searched for adult spine surgeries performed between October 2010 and September 2015 with FO or F and G/T charges. To obtain an unbiased treatment estimate, 1:1 propensity-score matching was used to identify FO and F + G/T cohorts. The cohorts were compared for rates of intraoperative, perioperative, postoperative and transfusion; blood loss-related, serious and other complications; hospital length-of-stay (LOS), surgical time, and volume of hemostat charged.Results: Among 40,335 spine surgeries, 15,105 FO and F + G/T matched pairs were compared. Significantly (p < 0.0001) lower percentages of FO than F + G/T cases received intraoperative (1.4% vs. 2.5%), perioperative (1.6% vs. 2.8%), postoperative (1.6% vs 3.0%), and any transfusion (2.3% vs. 4.3%). FO cases had significantly less blood loss complications than F + G/T cases (0.5% vs. 0.8%, p = 0.0022) and significantly (p < 0.0001) shorter hospital LOS (−0.45 days), surgical time (−39.0 min), and used less hemostat (−12.5 mL).Conclusions: Results from this observational hospital database analyses indicate that FO use in spine surgery is associated with lower blood transfusion use and blood loss complications compared to its use with adjunct non-flowable hemostatic agents. The shorter hospital stay, reduced surgical time, and less hemostat volume health-care utilization outcomes that favored FO versus combination use may translate to health system cost savings. Further validation of these findings using controlled clinical trials and cost-consequence studies is warranted.Clinical relevance: The use of flowable hemostatic agents alone may result in better clinical and possibly economic outcomes in spine surgery.

Evaluation of a Novel Fibrin Sealant Patch in Hemorrhage Control After Vascular or Hepatic Injury

Acute hemorrhage remains the leading cause of death in potentially survivable injuries. The use of topical hemostatic agents has increased over the last two decades with the evolution of damage control surgery. By 2008, the military widely adopted Combat Gauze as the hemostatic dressing of choice for compressible hemorrhage. The goal of this study was to compare the performance of a novel fibrin sealant patch to Combat Gauze in two clinically relevant models of hemorrhage. Yorkshire swine underwent unilateral femoral artery puncture or a grade V liver laceration with timed free bleeding then received either the fibrin patch or Combat Gauze packing with 3 minutes of standardized pressure. Animals were then resuscitated to maintain a mean arterial pressure of 60 mmHg for 4 hours. Hemostasis, blood loss, resuscitation volume, survival, vessel patency, and hematologic parameters were evaluated. Hemostasis was equivalent in both groups after hepatic and vascular injury. Survival was 80% in the fibrin patch vascular injury group and 100% in all other groups. Hematologic parameters were not significantly different between treatment groups. Femoral artery patency was 80% in both groups after vascular injury. With simulated ambulation after vessel injury, 60% of the Combat Gauze group and 80% of the fibrin patch group remained hemostatic (p > 0.05). In simulated re-exploration with packing removal, all animals rebled after hemostatic product removal. There was no significant difference in hemostasis between a novel fibrin patch and Combat Gauze after extremity arterial or hepatic injury. This novel fibrin patch may have a clinical advantage over the Combat Gauze, as it can be left in the body, thereby limiting the potential need for reoperation.