Hemostatic Control Research Articles

Use of a flowable haemostat versus an oxidised regenerated cellulose agent in primary elective cardiac surgery: economic impact from a UK healthcare perspective

BackgroundFlowable haemostatic agents have been shown to be superior to non-flowable agents in terms of haemostatic control and need for transfusion products in patients undergoing cardiac surgery. We investigated the economic impact of the use of a flowable haemostatic agent (Floseal) compared with non-flowable oxidised regenerated cellulose (ORC) agent in primary elective cardiac surgery from the perspective of the UK National Health Service (NHS).MethodsA cost-consequence framework based upon clinical data from a prospective trial and an observational trial and NHS-specific actual reference costs (2016) was developed to compare the economic impact of Floseal with that of ORC. The individual domains of care investigated comprised complications (major and minor) avoided, operating room time savings, surgical revisions for bleeding avoided and transfusions avoided. The cost impact of Floseal versus ORC on ICU days and extended bed days avoided was modelled separately.ResultsCompared with ORC, the use of Floseal would be associated with overall net savings to the NHS of £178,283 per 100 cardiac surgery patients who experience intraoperative bleeding requiring haemostatic therapy. Cost savings were apparent in all individual domains of care (complications avoided: £83,536; operating room time saved: £63,969; surgical revisions avoided: £34,038; and blood transfusions avoided: £22,317). Cost savings per 100 patients with Floseal over ORC in terms of ICU days avoided (n = 30) and extended bed days avoided (n = 51.7) were £57,960 and £21,965, respectively. A sensitivity analysis indicated that these findings remained robust when the model parameters representing the clinical benefit of Floseal over ORC were reduced by up to 20%.ConclusionsDespite higher initial acquisition costs, the use of flowable haemostatic agents achieves substantial cost savings over non-flowable agents in cardiac surgery. These cost savings commence during the operating theatre and appear to continue to be realised throughout the postoperative period.

Clinical Efficacy of a Kaolin-impregnated Dressing for Hemostatic Control in Diabetic Foot Ulcer Patients Receiving Anticoagulant Therapy in an Outpatient Clinic

Category: Diabetes Introduction/Purpose: Orthopedic physicians encounter many diabetes patients who receive anticoagulant treatment because vascular diseases are the chief causes of death and disability in these patients. In these patients, if surgery or other procedures are required, it is still unclear whether anticoagulation therapy administration should continue. After discontinuation of anticoagulation therapy, the risk of cardiovascular complications is increased, although complications of bleeding after surgery are decreased; this is a dilemma in the treatment of diabetic foot ulcer. The purpose of this study was to examine the effectiveness, safety, and hemostatic effect of kaolin-impregnated gauze on diabetic foot ulcer patients who continue to receive anticoagulants after surgical debridement. Methods: Twenty patients receiving anticoagulant medication with diabetic foot ulcers requiring surgical debridement were enrolled. Diabetic foot ulcers were treated using surgical debridement and a basic dressing protocol, which involved direct application of the dressing material to the wound bed. For the study group, a kaolin-impregnated dressing was used, and dry gauze was applied to patients in the control group. Patients were randomly assigned to either group, and we compared hemostatic efficacy and adverse effects between the two groups. The presence or absence of hemostasis was assessed 5 and 10 minutes after dressing application. Treatment was considered successful if bleeding ceased adequately and no extra hemostatic measures were required within 10 minutes. Results: In the 20 patients undergoing surgical debridement, there was no evidence of bleeding within 10 minutes of dressing application. Eight of the 10 patients treated with a kaolin-impregnated dressing achieved complete hemostasis within 5 minutes. Five of the 10 patients in the control group failed to achieve hemostasis within 10 minutes. No adverse effects were noted. Conclusion: The use of a kaolin-impregnated dressing appears to be a safe, feasible, and beneficial option for the management of diabetic foot ulcer patients with a high risk of bleeding.

Ten-year study of postoperative complications following dental extractions in patients with inherited bleeding disorders

Dental extractions challenge the body’s haemostatic mechanism. Postoperative bleeding from dental extraction can be prolonged, or even life threatening in patients with inherited bleeding disorders. Pre- and postoperative clotting factor replacements or systemic desmopressin (ddAVP) have been advocated at our institution to prevent bleeding complications in these patients. This study aimed to assess the postoperative bleeding rate in patients with inherited bleeding disorders that underwent dental extractions at our institution between 2003 and 2012. Patients with inherited bleeding disorders such as haemophilia A, haemophilia B, and von Willebrand’s disease were included. Retrospective chart review was conducted. The result showed 53 extraction events occurred in 45 patients over the 10-year period. Ten out of 53 extraction events (18.9%) had postoperative bleeding requiring further factor replacement or ddAVP. Postoperative bleeding in one patient with mild haemophilia A was complicated by the development of inhibitors. Type and severity of bleeding disorder, bone removal, and use of a local haemostatic agent did not have any significant effect on postoperative bleeding. Despite the use of perioperative factors and desmopressin, the postoperative bleeding rates remain high for patients with inherited bleeding disorders. More studies are required to assess the safety and effectiveness of using local haemostatic control to achieve haemostasis following extractions.

Global clotting assays - monitoring the effect of by-passing agents in haemophilia patients with inhibitors

Abstract The development of FVIII/FIX inhibitor alloantibodies represents a severe complication requiring specific laboratory evaluation for establishing a life-saving therapy regimen. Our preliminary study aimed at elaborating a laboratory strategy for monitoring the effectiveness of Activated Prothrombin Complex Concentrate (APCC) and recombinant activated factor VII (rFVIIa) in haemophiliacs with inhibitors, by checking the reliability and clinical value of three complementary assays: clotting-time based coagulometry, thrombelastography (TEG) and thrombin generation assay (TGA). The investigations were performed on 7 patients with severe haemophilia A with high titer inhibitors treated for 12 episodes of severe bleedings, 5 of them for surgical interventions. After the administration of bypassing agents (BPAs) the clotting-time based assay brought changes only on prothrombin (p<0.01), potentially signaling a thrombotic risk, without any impact on the global hemostasis. TEG displayed prompt significant improvement only after rFVIIa (90μg/kg). TGA revealed significantly improved values for peak and velocity index, time to peak and start tail after both BPAs. Despite some disparities between biological hemostatic phenotype and clinical response to therapy, we concluded that TEG and TGA are the only current exploratory assays, expressing the quality of haemostatic control, representing a real support for a personalized, adapted therapy in hemophilia with inhibitors.

Reintroduction of anti-thrombotic therapy after a gastrointestinal haemorrhage: if and when?

Gastrointestinal haemorrhage is a common clinical scenario and, in those using antithrombotic agents, the risk is significantly increased. Management of these patients, in terms of initial resuscitation is well established and numerous guidelines exist in this area. However, few studies have addressed the subsequent dilemma of if and when antithrombotic agents should be reintroduced. Consequently, practice is variable and not necessarily evidenced-based. Overall, for patients that are either anticoagulated or using antiplatelet drugs for secondary prophylaxis, there is a clear benefit to restarting these agents. However, there is limited data to guide when this should occur. For individuals at low risk of re-bleeding, current guidelines suggest single agent aspirin can be continued without interruption, assuming haemostatic control has been confirmed endoscopically. For those at higher bleeding risk, aspirin should be withheld, but reintroduced early (within 3days of index endoscopy). However, randomised evidence is lacking, as are studies including more modern agents or combined anticoagulant/ antiplatelet regimens. As such, guidance statements are limited and management suggestions must be extrapolated from clinical trials, retrospective studies and data relating specifically to warfarin and aspirin. The intention of this review is to summarise what evidence is available and, where this is lacking, suggest pragmatic management options based on a risk-benefit assessment of thromboembolism and recurrent bleeding.

Laparoscopic donor nephrectomy, complications and management: a single center experience.

To present our experience with laparoscopic donor nephrectomy (LDN), our complications and management modalities. Material and methods: Fifty-one transperitoneal LDNs performed in our clinic between the years 2011, and 2015, were evaluated retrospectively. Demographic characteristics of the patients, operative and postoperative data and complications were evaluated. Nineteen female and 32 male patients with ages ranging from 24 to 65 years underwent left- (n=44), and right-sided (n=7) LDNs. Six patients had two, and one patient three renal arteries. Mean operation time was 115±11 (min-max: 90-150) minutes, and mean warm ischemia time 111±9 (min-max: 90-140 sec) seconds. Mean hospital stay was found to be 2.5±0.5 days. No patient needed to switch to open surgery. In one patient, lumbar vein was ruptured, and hemostatic control was achieved laparoscopically. Postoperative paralytic ileus developed in two patients. Three patients had postoperative atelectasis, and a febrile (38.1°C) episode. LDN is a minimally invasive method with advantages of short hospital stay, less analgesic requirement, and better cosmetic results. However it should be performed by surgeons with advanced laparoscopic experience.

Perioperative Management for Congenital Factor XI Deficiency; A Systematic Review

Background: Congenital Factor XI (FXI) deficiency is the most common rare bleeding disorder, characterized by production defect of FXI. Bleeding manifestation is usually mild and associated with trauma or surgery. The treatment options during surgery include plasma, FXI concentrate, recombinant activated factor VII (rFVIIa), etc. This study aimed to investigate the efficacy of hemostatic control and thrombotic complications in patients with congenital FXI deficiency who underwent surgery or an invasive procedure.Methods: We conducted a systematic search in MEDLINE, EMBASE and CENTRAL database from inception to March 2016. We included the case reports and case series of patients with congenital FXI deficiency. Studies must report the perioperative treatment regimen, hemostatic outcome and thromboembolic complication. The pre- and post-FXI levels were collected. The primary outcome was the efficacy of hemostatic control and the safety outcome was thromboembolic complication.Results: There were 87 studies included in this review, involving 310 patients with congenital FXI deficiency. Median age was 49.5 years (range 0.3 to 94). Forty percent of the patients were male. Median baseline FXI level was 6.0% (range <1 to 75.0). FXI concentrate was the most common treatment (48.39%), following by plasma (21.61%), rFVIIa (12.90%) and others (FEIBA, DDAVP, tranexamic acid and no treatment; 17.1%). Hemostatic control was found to be good or excellent in 118 patients (88.06%) who had major surgery, 65 patients (92.85%) in minor surgery and 47 patients (97.91%) in dental procedure, Table 1. Thromboembolic events were reported in 7/150 (4.67%) patients treated with FXI concentrate and 4/34 (11.76%) patients treated with rFVIIa, Table 2. None of patients receiving plasma, FEIBA, DDAVP or tranexamic acid had thrombosis.Conclusion: Hemostatic control during perioperative periodwas achieved in majority of patients with congenital FXI. Peak plasma FXI should be obtained in patients treated with plasma or FXI concentrate with the target FXI of 60-70% for major surgery and 40-50% for minor surgery. With respect to the higher risk of thromboembolic complication, we recommend plasma over FXI concentrate and rFVIIa for perioperative treatment in patients with FXI deficiency. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Perioperative Management of Von Willebrand Disease, a Systematic Review and Meta-Analysis

Background: von Willebrand disease (vWD) is the most common inherited bleeding disorder characterized by quantitative or qualitative defect of von Willebrand factor (vWF) production. Patients with vWD are at high risk of bleeding during surgery. We aimed to evaluate the efficacy and safety of factor VIII (FVIII)/vWF concentrates and DDAVP for bleeding prevention in vWD patients who undergo surgery or an invasive procedure.Methods:The electronic searches were performed in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases. The articles published from inception to January 2016 were eligible for inclusion in this review. Studies will be included if they are observational studies or clinical trials of pediatric or adult patients who were laboratory confirmed vWD (type 1 or type 2 or type 3). We excluded case report or case series with less than 5 patients, acquired vWD and incomplete outcome reports. The primary outcome was the efficacy of hemostatic control as defined by studies. We calculated pooled incidence of the patient who achieve good or excellent hemostatic control with corresponding 95% confidence interval using single proportion meta-analysis. The secondary outcomes were adverse outcomes from FVIII/vWF and DDAVP.Results: After screening, there were 54 studies included in the meta-analysis. Forty-five studies investigated the efficacy of vWF/FVIII. Pooled analysis revealed that 98.4% (95% CI; 97.8-99.1%, I2=45.5%) of FVIII/vWF treated patients achieved excellent or good hemostasis. Subgroup analysis according to type of surgery revealed that excellent or good hemostasis was 99.4% (95%CI; 98.4-100%, I2=0%) in major surgery and 99.0% (95%CI; 98.2-99.9%, I2=0%) in minor surgery, Table 1. Adverse effects were observed in 0.2% (95% CI; 0-0.4, I2=85.1%) patients who received FVIII/vWF. The reported adverse effects from FVIII/vWF concentrates included phlebitis, shortness of breath, chest tightness, urticaria, pruritus, chill, malaise, fever, paresthesia, transient elevation of liver function test, nausea, vomiting, dizziness, headache and parvovirus B 19 seroconversion. Thromboembolism occurred in 0.17% of patients who received vWF/FIII. There were 26 studies investigating DDAVP during surgery. Hemostasis was excellent or good in 98.0% (95%CI; 97.0-99.0%, I2=26.3%. In dental procedure, 99.0% of patients receiving DDAVP (95%CI; 97.6-100%, I2=0%) achieved excellent or good hemostasis. Subgroup analysis showed that good/excellent hemostasis was found in 96.9% of pediatric patients (95%CI; 95.1-98.7%, I2=58.8%) and 96.9% (95%CI; 92.7-100%, I2= 0%) in adult patients, Table 2. Adverse effects from DDAVP were reported in 1.2% (95%CI; 0.4-2.1%, I2=95%). Hyponatremia of any level was observed in 16.1% (95%CI; 8.9-22.4%, I2=94.1%). The other reported adverse effects were headache, fatigue, rash, seizure (from hyponatremia), flushing, dizziness, peripheral edema, nausea and vomiting. No thromboembolic event was found in DDAVP treated patients.Conclusions: Both FVIII/vWF concentrates and DDAVP are effective and safe for bleeding prevention during surgery or an invasive procedure in vWD patients. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Low-factor consumption for major surgery in haemophilia B with long-acting recombinant glycoPEGylated factor IX.

Surgery in patients with haemophilia B carries a high risk of excessive bleeding and requires adequate haemostatic control until wound healing. Nonacog beta pegol, a long-acting recombinant glycoPEGylated factor IX (FIX), was used in the perioperative management of patients undergoing major surgery. To evaluate the efficacy and safety of nonacog beta pegol in patients with haemophilia B who undergo major surgery. This was an open-label, multicentre, non-controlled surgery trial aimed at assessing peri- and postoperative efficacy and safety of nonacog beta pegol in 13 previously treated patients with haemophilia B. All patients received a preoperative nonacog beta pegol bolus injection of 80 IU kg-1 . Postoperatively, the patients received fixed nonacog beta pegol doses of 40 IU kg-1 , repeated at the investigator's discretion. Safety assessments included monitoring of immunogenicity and adverse events. Intraoperative haemostatic effect was rated 'excellent' or 'good' in all 13 cases. Apart from the preoperative injection, none of the patients needed additional doses of nonacog beta pegol on the day of surgery. The median number of postoperative doses of nonacog beta pegol was 2.0 from days 1 to 6 and 1.5 from days 7 to 13. No unexpected intra- or postoperative complications were observed including deaths or thromboembolic events. No patients developed inhibitors. These results indicated that nonacog beta pegol was safe and effective in the perioperative setting, allowing major surgical interventions in patients with haemophilia B with minimal peri- and postoperative concentrate consumption and infrequent injections as reported with standard FIX products.

Hemorrhage after Major Pancreatic Resection: Incidence, Risk Factors, Management, and Outcome.

Hemorrhage is a rare but dreaded complication after pancreatic surgery. The aim of this study was to examine the incidence, risk factors, management, and outcome of postpancreatectomy hemorrhage in a tertiary care center. A retrospective observational study was conducted on 500 consecutive patients undergoing major pancreatic resections at our institution. Postpancreatectomy hemorrhage was defined according to the International Study Group of Pancreatic Surgery criteria. A total of 68 patients (13.6%) developed postpancreatectomy hemorrhage. Thirty-four patients (6.8%) had a type A, 15 patients (3.0%) had a type B, and the remaining 19 patients (3.8%) had a type C bleed. Postoperative pancreatic fistula Grades B and C and bile leakage were significantly associated with severe postpancreatectomy hemorrhage on multivariable logistic regression. For patients with postpancreatectomy hemorrhage Grade C, the onset of bleeding was in median 13 days after the index operation, ranging from 1 to 85 days. Twelve patients (63.2%) had sentinel bleeds. Surgery lead to definitive hemostatic control in six of eight patients (75.0%). Angiography was able to localize the bleeding source in 8/10 (80.0%) cases. The success rate of angiographic hemostasis was 8/8. (100.0%). The mortality rate among patients with postpancreatectomy hemorrhage Grade C was 2/19 (10.5%), and both fatalities occurred late as a consequence of eroded vessels in association with pancreaticogastrostomy. Delayed hemorrhage is a serious complication after major pancreatic surgery.Sentinel bleed is an early warning sign. Postoperative pancreatic fistula and bile leakage are important risk factors for severe postpancreatectomy hemorrhage.

PTH-127 Endoscopic Variceal Band Ligation (EVBL) at The 37 Military Hospital, Accra-Ghana: Our Experience with The Euro-Ligator-Universal (Euro Multiband Ligator)

Introduction Bleeding gastro-eosophageal varices are the 3 rd commonest cause of UGI bleeding in Ghana and have a high mortality. EVBL is an effective, safe treatment for oesophageal varices but single use, preloaded ligators are unaffordable in developing countries. We report our early experience of the re-usable Euro-Ligator for variceal banding. Methods The Euro-Ligator is the first re-usable multiple band ligator. It operates on a different principle to other ligators. A rotating driver is locked into the instrument channel and pre-loaded bands are deployed as an inner cylinder is withdrawn. Training in the use of the Euro-Ligator was provided by a visiting team from the University Hospitals of Leicester, funded by the British Society of Gastroenterology. During a one day course (October ‘15) the endoscopy team at 37 Military received instruction in loading the bands, intubation, band deployment and disinfection. An instruction video of each step was produced. During the course 5 patients were successfully banded under the supervision of the visiting team. Dedicated lists for variceal banding were established. Results To date, 15 EVBL sessions have been performed on 7 patients (6 males, age range 16 to 62). In all, 60 bands have been deployed with a successful band deployment rate of 55/60 (91.6%). The mean number of bands used per session was 3.7. All procedures were elective day cases after an index bleed & performed under conscious sedation. No mortality was recorded during the procedures & all patients were discharged home the same day. We have not seen deep ulceration, perforation or aspiration pneumonia. One patient was lost to follow up after the index procedure and 1 patient died 2 weeks after the initial session from Hepatic Failure (Child Pugh C). In the remaining 5 patients under follow-up, haemostatic control has been achieved with no further bleeding episodes reported. Complete eradication has now been achieved in 1 patient. Conclusion This preliminary case report gives us some insight and working experience into the use of the multiband Euro-Ligator. We found the equipment easy to use and technically effective in the endoscopic treatment of oesophageal varices. We need to adhere to stringent disinfection and cleaning protocols to ensure long term safety in our patients and evaluate the clinical and cost effectiveness over a longer period. However, the Euroligator is a major advance in the management of bleeding oesophageal varices in the developing world Disclosure of Interest None Declared

Assessment of the Hemostatic Parameters and Platelet Function on Thromboelastometry and Impedance Aggregometry in Hemodialysis Patients Qualified for Kidney Transplantation: Preliminary Report

BackgroundChronic kidney disease is one of the medical conditions that affect hemostasis. Patients undergoing hemodialysis present both hemorrhagic and prothrombotic tendencies. Platelet adhesion to the artificial surface of the dialyzer's membrane, blood vessel endothelial wall disruption, and quantitative and qualitative changes in clothing factors are thought to be causative agents of the above-mentioned conditions. Thromboelastometry and impedance aggregometry enable precise assessment of clot formation and platelet function abnormalities, including changes related to chronic renal failure in patients undergoing renal replacement therapy. MethodsA prospective study with control group was designed. The study group consisted of 17 adults with diagnosed chronic renal failure undergoing hemodialysis. The control group consisted of 13 healthy volunteers. EXTEM and FIBTEM tests in rotational thromboelastometry and TRAPtest in impedance aggregometry analyzer were performed. ResultsEXTEM parameter test results were comparable between analyzed groups, whereas FIBTEM test results were significantly increased in the study group. Platelet aggregation as measured by the TRAPtests was significantly decreased in patients undergoing hemodialysis. ConclusionsIn end-stage renal disease patients undergoing hemodialysis, whole-blood clot formation is not disturbed, even though platelet dysfunction occurs. Increased fibrin clot formation reflected by FIBTEM results may compensate the observed platelet disorders. The compilation of ROTEM and Multiplate may support appropriate hemostatic control and decision-making during kidney transplantation.

Determination of efficacy of a novel alginate dressing in a lethal arterial injury model in swine

IntroductionAlginate is a biocompatible polysaccharide that is commonly used in the pharmaceutical, biomedical, cosmetic, and food industries. Though solid dressings composed of alginate can absorb water and promote wound healing, they are not effective hemostatic materials, particularly against massive hemorrhage. The purpose of this study is to attempt to increase the hemostatic capabilities of alginate by means of hydrophobic modification. Previous studies have illustrated that modifying a different polysaccharide, chitosan, in this way enhances its hemostatic efficacy as well as its adhesion to tissue. Here, it was hypothesized that modifying alginate with hydrophobic groups would demonstrate analogous effects. MethodsFifteen Yorkshire swine were randomized to receive hydrophobically-modified (hm) alginate lyophilized sponges (n=5), unmodified alginate lyophilized sponges (n=5), or standard Kerlix™ gauze dressing (n=5) for hemostatic control. Following a splenectomy, arterial puncture (6mm punch) of the femoral artery was made. Wounds were allowed to freely bleed for 30s, at which time dressings were applied and compressed for 3min in a randomized fashion. Fluid resuscitation was given to preserve the baseline mean arterial pressure. Wounds were monitored for 180min after arterial puncture, and surviving animals were euthanized. ResultsBlood loss for the hm-alginate group was significantly less than the two control groups of (1) alginate and (2) Kerlix™ gauze (p=<0.0001). Furthermore, 80% of hm-alginate sponges were able to sustain hemostasis for the full 180min, whereas 0% of dressings from the control groups were able to achieve initial hemostasis. ConclusionsHm-alginate demonstrates a greatly superior efficacy, relative to unmodified alginate and Kerlix™ gauze dressings, in achieving hemostasis from a lethal femoral artery puncture in swine. This is a similar result as has been previously described when performing hydrophobic modification to chitosan. The current study further suggests that hydrophobic modification of a hydrophilic biopolymer backbone can significantly increase the hemostatic capabilities relative to the native biopolymer.

Management of Intra-Abdominal Hemorrhagic Shock Using REBOA

Hemorrhage is the leading cause of potentially preventable death after a traumatic injury. 1 Scott DJ Eliason JL Villamaria C et al. A novel fluoroscopy-free, resuscitative endovascular aortic balloon occlusion system in a model of hemorrhagic shock. J Trauma Acute Care Surg. 2013; 75: 122-128 Crossref PubMed Scopus (104) Google Scholar , 2 Brenner ML Moore LJ DuBose JJ et al. A clinical series of resuscitative endovascular balloon occlusion of the aorta for hemorrhage control and resuscitation. J Trauma Acute Care Surg. 2013; 75: 506-511 Crossref PubMed Google Scholar , 3 Norii T Crandall C Terasaka Y Survival of severe blunt trauma patients treated with resuscitative endovascular balloon occlusion of the aorta compared with propensity score-adjusted untreated patients. J Trauma Acute Care Surg. 2015; 78: 721-728 Crossref PubMed Scopus (141) Google Scholar Noncompressible torso hemorrhage (NCTH), which is a disruption of the vascular activity of the axial torso vessels, pulmonary parenchyma, solid organs, or the bony pelvis, accompanied by shock, 4 Morrison JJ Stannard A Rasmussen TE et al. Injury pattern and mortality of noncompressible torso hemorrhage in UK combat casualties. J Trauma Acute Care Surg. 2013; 75: S263-S268 Crossref PubMed Scopus (79) Google Scholar has an associated mortality of approximately 45%. 5 Kisat M Morrison JJ Hashmi ZG et al. Epidemiology and outcomes of non-compressible torso hemorrhage. J Surg Res. 2013; 184: 414-421 Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar A significant number of these deaths often occur because of the delay in definitive hemorrhage control in an operative theater or interventional radiology suite. Therefore, a need for adjunct hemorrhage control is paramount to attaining temporary control of bleeding until definitive hemostasis can be achieved. 3 Norii T Crandall C Terasaka Y Survival of severe blunt trauma patients treated with resuscitative endovascular balloon occlusion of the aorta compared with propensity score-adjusted untreated patients. J Trauma Acute Care Surg. 2015; 78: 721-728 Crossref PubMed Scopus (141) Google Scholar , 4 Morrison JJ Stannard A Rasmussen TE et al. Injury pattern and mortality of noncompressible torso hemorrhage in UK combat casualties. J Trauma Acute Care Surg. 2013; 75: S263-S268 Crossref PubMed Scopus (79) Google Scholar , 5 Kisat M Morrison JJ Hashmi ZG et al. Epidemiology and outcomes of non-compressible torso hemorrhage. J Surg Res. 2013; 184: 414-421 Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar A key to improving outcomes in patients with NCTH is a “bundle” of measures that can facilitate early diagnosis, rapid control of hemorrhage, systemic and topical hemostatic support, and a short time at the scene. In the past decade a paradigm shift has occurred in treatment strategies and transfusion algorithms, with emphasis on hemostatic or damage control resuscitation. 2 Brenner ML Moore LJ DuBose JJ et al. A clinical series of resuscitative endovascular balloon occlusion of the aorta for hemorrhage control and resuscitation. J Trauma Acute Care Surg. 2013; 75: 506-511 Crossref PubMed Google Scholar , 6 Stannard A Eliason JL Rasmussen TE Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011; 71: 1869-1872 Crossref PubMed Scopus (355) Google Scholar Jennifer Adamski is Assistant Professor, Clinical Track, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA.

Differences in Thyroidectomy Outcomes Based on Surgical Method: A Comparison of LigaSure Precise, Harmonic Focus, and Traditional Methods

New surgical devices have been developed to improve haemostatic control and vascular closure in thyroid surgery. Here, we compare the efficacy and clinical outcomes of 3 surgical methods, Harmonic Focus, LigaSure Precise, and the traditional suture-ligation method, in patients undergoing total thyroidectomies. This retrospective study compared total thyroidectomies performed between July 2008 and August 2012. Thyroidectomies were performed in 243 patients using Harmonic Focus (n = 81), LigaSure Precise (n = 81), and traditional suture-ligation (n = 81). No significant differences were observed among groups in terms of patient demographics, thyroid weight, pathological diagnoses, pre- and postoperative calcium levels, postoperative complications, length of hospitalization, and clinical outcomes. The Harmonic Focus approach showed an ∼15% shortening in operating time relative to the suture-ligation group; no statistically significant differences were detected between the LigaSure and traditional suture-ligation groups. All 3 methods were found to be both safe and effective. Operating time was significantly shorter in the Harmonic Focus group; no differences in terms of postoperative complications were observed among groups.

Percutaneous removal using Perclose ProGlide closure devices versus surgical removal for weaning after percutaneous cannulation for venoarterial extracorporeal membrane oxygenation

The removal of arterial cannulas using a Perclose device (Abbott Vascular, Clonmel, Tipperary, Ireland) has not been reported in patients undergoing venoarterial extracorporeal membrane oxygenation (ECMO). We investigated the procedural outcomes and complications of percutaneous device closure vs surgical repair for hemostatic control of the arterial access site in weaning from venoarterial ECMO. Between September 2012 and December 2014, 115 patients with ECMO weaned by percutaneous or surgical access were enrolled. The percutaneous technique used two ProGlide devices (Abbott Vascular) by direct puncture of an arterial cannula at the time of weaning off ECMO. The primary outcomes were composite complications of open repair at the insertion site, limb ischemia after removal of the arterial cannula, removal site infection, pseudoaneurysm, distal part embolization, and 10minutes or more manual compression at the weaning site. The percutaneous technique was performed on 56 patients, and the surgical exposure technique was performed on 59. Technical success was not significantly different between the percutaneous and surgical groups (85.7% vs 86.4%; P=1.0) although the procedure duration (17.15± 9.38minutes vs 64.33± 31.67minutes; P< .001) was shorter in the percutaneous access group. A composite of procedure-related complications and length of stay in the intensive care unit after weaning was not significantly different between groups (17.9% vs 28.8%; P= .19 and 16.82± 38.53days vs 19.69± 21.40days; P= .62). Percutaneous access using two Perclose ProGlide devices was a feasible and safe strategy for weaning from ECMO.

Gauze with self-propelling microparticles containing thrombin and tranexamic acid drastically improved survival in a swine model of lethal hemorrhage

Event Abstract Back to Event Gauze with self-propelling microparticles containing thrombin and tranexamic acid drastically improved survival in a swine model of lethal hemorrhage Alex St. John1, James R. Baylis2, Xu Wang1, Esther B. Lim1, Matt L. Statz1, Diana Chien1, Susan A. Stern1, Christian J. Kastrup2 and Nathan J. White1 1 University of Washington, Emergency Medicine, United States 2 University of British Columbia, Michael Smith Laboratories, Canada Introduction: Severe bleeding from large arterial wounds is a leading cause of death after trauma. Hemostatic gauzes containing coagulation activators are currently used to pack and compress wounds but are less effective in anatomical locations where compression cannot be performed, likely because their activators are pushed away from the site of vessel injury by the hemorrhaging blood. Gauze impregnated with self-propelling microparticles that disperse hemostatic activators throughout the wound, including upstream against hemorrhage flow, may be useful in these situations. Methods: A self-propelling hemostatic bandage was created by binding thrombin to calcium carbonate microparticles and coating these particles on cotton bandage in the presence of solid protonated tranexamic acid (TXA). Contact with blood causes brisk release of CO2 and propulsion of microparticles against flowing blood to deliver the thrombin and induce hemostasis. Non-protonated TXA was substituted to form a non-propelling control. Bleeding was induced in 29 immature female swine using a 5 mm femoral arteriotomy. Pigs were randomized into 1 of 4 packing interventions without wound compression: negative control, kaolin hemostatic gauze control (Combat Gauze™) (KG), propelled thrombin gauze (PTG), or non-propelled thrombin gauze control (NPTG). All animals then received intravenous fluids to restore blood pressure for up to 3 hours. Survival was compared using Kaplan-Meier log rank, and continuous variables (i.e., blood loss and laboratory values) were compared using repeated measures ANOVA. Results: Survival was improved with PTG (3-hr survival: 8/8, 100%) compared to KG (3/8, 37.5%, p=0.01) and compared to NPTG (2/8, 25.0%, p=0.01). Total and post-intervention external blood loss were similar in all gauze groups (p>0.05). Thromboelastogram maximum amplitude was higher with PTG compared to NPTG at 150 minutes but was otherwise not significantly different. Fibrinogen concentration did not differ across groups. Discussion: Propelled thrombin gauze improved survival in this lethal bleeding model. Self-propelling particles could be used to deliver a number of pro-thrombotic or wound-healing agents throughout an actively hemorrhaging wound to promote hemostasis and recovery. Keywords: Drug delivery, biomaterial, medical application, Bioactive molecule Conference: 10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016. Presentation Type: Poster Topic: Biomaterials in thrombosis and hemostasis Citation: St. John A, Baylis JR, Wang X, Lim EB, Statz ML, Chien D, Stern SA, Kastrup CJ and White NJ (2016). Gauze with self-propelling microparticles containing thrombin and tranexamic acid drastically improved survival in a swine model of lethal hemorrhage. Front. Bioeng. Biotechnol. Conference Abstract: 10th World Biomaterials Congress. doi: 10.3389/conf.FBIOE.2016.01.02418 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 27 Mar 2016; Published Online: 30 Mar 2016. Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Alex St. John James R Baylis Xu Wang Esther B Lim Matt L Statz Diana Chien Susan A Stern Christian J Kastrup Nathan J White Google Alex St. John James R Baylis Xu Wang Esther B Lim Matt L Statz Diana Chien Susan A Stern Christian J Kastrup Nathan J White Google Scholar Alex St. John James R Baylis Xu Wang Esther B Lim Matt L Statz Diana Chien Susan A Stern Christian J Kastrup Nathan J White PubMed Alex St. John James R Baylis Xu Wang Esther B Lim Matt L Statz Diana Chien Susan A Stern Christian J Kastrup Nathan J White Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.

Abdominal Compartment Syndrome in a Patient with Hemophilia A with a High Titer Inhibitor after a Minor Trauma

Abdominal compartment syndrome (ACS) is a life-threatening condition which can occur in patients with hemophilia although they have trivial traumas. Hemostatic control for bleeding episodes in hemophilia patients with inhibitors is difficult particularly when the availability of bypassing agents, recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrate (APCC), is constrained. Plasma exchange with continuous infusion of factor concentrate has been reported as a life-saving intervention in these patients. We reported a teenager with severe hemophilia A and a high-titer inhibitor who underwent two surgeries for ACS which developed after a minor trauma. Computerized tomography angiogram (CTA) of abdomen revealed a large pelvic hematoma and a bleeding from the sigmoidal artery. He underwent an abdominal angiography followed by the first surgery to relieve the ACS, and the second surgery for abdominal closure. The patients received plasma exchange with cryo-removed plasma peri-operatively. High-dose factor VIII (FVIII) concentrate (100 U/kg) was started after plasma exchange followed by continuous infusion at the rate 14 units/kg/hour for 7 days. rFVIIa and APCC concomitant with tranexamic acid were used for breakthrough bleeding. He received six times of plasma exchange, three doses of rFVIIa and five doses of APCC. Bleeding was successfully stopped and the titers of inhibitor decreased from the maximum of 4,400 BU to 3,680 BU. Plasma exchange and continuous FVIII infusion can be considered as an option for life-threatening hemorrhage in hemophilia patients with high-titer inhibitors in the countries where an access to bypassing agents is limited.

Perioperative Efficacy of an Extended Half-Life, Pegylated, Full-Length, Recombinant Factor VIII (BAX 855) in Individual Procedures

BAX 855 is a pegylated full-length recombinant factor VIII (PEG rFVIII) built on rFVIII (ADVATE) with an extended half-life and is intended for prophylaxis and the treatment of bleeding in patients with hemophilia A.1 This phase 3 surgery study is evaluating the efficacy and safety of BAX 855 for the perioperative control of hemostasis. Patients' informed consent and appropriate ethics committee approvals were obtained. Elective procedures were prospectively classified (major or minor) by the investigator/surgeon and major emergency surgeries were excluded. The target trough FVIII levels for major and minor surgeries were to be ≥80% and 30-60%, respectively. Each patient's pharmacokinetic (PK) profile was used to guide the BAX 855 dose and infusion frequency. BAX 855 PK were consistent with previous PK assessments with terminal half-life ranging from 8.81 to 18.06 hours for the 15 patients in this study.In this interim analysis, 15 male previously treated patients (PTPs) ranging from 19 to 52 years of age have undergone 15 procedures in 7 countries. Individual procedure profiles are compiled to evaluate the control of hemostasis for BAX 855. There were 11 major procedures: 6 orthopedic (3 knee replacements, 2 arthroscopic synovectomies, 1 elbow cyst extirpation) and 5 non-orthopedic procedures (3 dental [root canals for 2 teeth, 2 extractions of ≥4 teeth, 1 radicular cyst removal], 1 cardiovascular [mediport placement], 1 abdominal [gastric band insertion]). The 4 minor surgeries comprised 1 synoviorthesis, 1 dental, 1 dermatological and 1 endoscopy (radiosynovectomy) procedure.Efficacy was evaluated by the surgeon or investigator's rating of hemostatic control using 4-point scale which was based on blood loss and by comparing actual blood loss with predicted blood loss which was specified by the surgeon for non-hemophilia patients prior to the procedure. For all procedures, the hemostatic control of BAX 855 was rated "excellent" for the intraoperative (during the procedure), postoperative (24 hours after completion of the procedure), and perioperative (from start of the procedure until discharge or day 14) periods, except for 1 minor dental procedure in which postoperative efficacy was rated "good" and 1 minor procedure in which a postoperative rating was not provided (for both of these procedures intra- and perioperative ratings were "excellent").Actual blood loss (ABL) for the intraoperative and postoperative periods were compared with predicted average and maximum values. Intraoperative ABL for all minor and major procedures was less than or equal to predicted averages and maximums, except for 1 minor procedure in which the ABL was greater than the predicted average and maximum and 1 major procedure which did not have ABL recorded. Postoperative ABL was less than or equal to predicted averages and maximums for 4/4 minor procedures and 5 major procedures. For 4 major procedures, postoperative ABL was greater than or equal to predicted average, but less than predicted maximums. For the remaining major procedure (synovectomy with general anesthesia) with reported ABL, postoperative ABL was greater than the predicted the average and maximum - the efficacy assessments at all periods for this procedure were considered "excellent".These results demonstrate the efficacy of BAX 855 for the perioperative control of hemostasis in patients with severe hemophilia A.1 Konkle BA, Stasyshyn O, Chowdary P et al. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015; Link to Publisher's site: http://www.bloodjournal.org/content/bloodjournal/early/2015/07/08/blood-2015-03-630897.full.pdf DisclosuresBrand:CSL Behring: Consultancy; Pfizer: Consultancy; Bayer: Consultancy; Baxalta: Consultancy, Research Funding; Novo Nordisk: Consultancy; Biotest: Consultancy. Gruppo:Baxalta: Consultancy, Research Funding; Novo Nordisk: Consultancy; Pfizer: Consultancy; Alexion: Speakers Bureau. Wynn:Baxalta: Research Funding. Griskevicius:Novartis: Consultancy, Research Funding; Baxalta: Research Funding. Fernanda Lopez Fernandez:Baxalta: Research Funding. Dvorak:Baxalta: Employment, Equity Ownership. Patrone:Baxalta: Employment, Equity Ownership. Abbuehl:Baxalta: Employment, Equity Ownership.

Acquired haemophilia: an overview for clinical practice.

Acquired haemophilia is a potentially life-threatening bleeding disorder caused by the development of autoantibodies against coagulation factors, most commonly against factor (F) VIII (acquired haemophilia A; AHA). In around half of patients, an underlying disorder is associated with AHA; the remaining cases are idiopathic. Typically, the disorder presents with bleeding, ranging from mild to life- and limb-threatening, in patients with no personal or family bleeding history. Diagnosis involves an isolated prolongation of the activated partial thromboplastin time, without correction in mixing studies, low FVIII activity levels and evidence of a FVIII inhibitor. As AHA is rare, a lack of familiarity of the condition may result in delayed diagnosis, and prompt haemostatic control is required to reduce morbidity and mortality. Bypassing agents (recombinant activated factor VII or activated prothrombin complex concentrates) can be used to control acute bleeding, and immunosuppression is necessary to eradicate the inhibitor. As clinical trials in this rare and heterogeneous disease are difficult, current evidence comes from observational studies, including registries. This review will focus on the diagnostic and therapeutic challenges of AHA and summarise how understanding of this complex condition has increased based on recent registry data.