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Novel use of XSTAT 30 for mitigation of lethal non-compressible torso hemorrhage in swine.

ABSTRACT: BACKGROUND:Management of Non-Compressible Torso Hemorrhage (NCTH) consists primarily of aortic occlusion which has significant adverse outcomes, including ischemia-reperfusion injury, in prolonged field care paradigms. One promising avenue for treatment is through use of RevMedx XSTAT 30™ (an FDA approved sponge-based dressing utilized for extremity wounds). We hypothesized that XSTAT 30™ would effectively mitigate NCTH during a prolonged pre-hospital period with correctable metabolic and physiologic derangements. METHODS AND FINDINGS:Twenty-four male swine (53±2kg) were anesthetized, underwent line placement, and splenectomy. Animals then underwent laparoscopic transection of 70% of the left lobe of the liver with hemorrhage for a period of 10min. They were randomized into three groups: No intevention (CON), XSTAT 30™-Free Pellets (FP), and XSTAT 30™-Bagged Pellets (BP). Animals were observed for a pre-hospital period of 180min. At 180min, animals underwent damage control surgery (DCS), balanced blood product resuscitation and removal of pellets followed by an ICU period of 5 hours. Postoperative fluoroscopy was performed to identify remaining pellets or bags. Baseline physiologic and injury characteristics were similar. Survival rates were significantly higher in FP and BP (p<0.01) vs CON. DCS was significantly longer in FP in comparison to BP (p = 0.001). Two animals in the FP group had pellets discovered on fluoroscopy following DCS. There was no significant difference in blood product or pressor requirements between groups. End-ICU lactates trended to baseline in both FP and BP groups. CONCLUSIONS:While these results are promising, further study will be required to better understand the role for XSTAT in the management of NCTH.

SUBMITTER: Bonanno AM

PROVIDER: S-EPMC7673511 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Novel use of XSTAT 30 for mitigation of lethal non-compressible torso hemorrhage in swine.

Bonanno Alicia M AM Graham Todd L TL Wilson Lauren N LN Ross James D JD

PloS one 20201118 11

<h4>Background</h4>Management of Non-Compressible Torso Hemorrhage (NCTH) consists primarily of aortic occlusion which has significant adverse outcomes, including ischemia-reperfusion injury, in prolonged field care paradigms. One promising avenue for treatment is through use of RevMedx XSTAT 30™ (an FDA approved sponge-based dressing utilized for extremity wounds). We hypothesized that XSTAT 30™ would effectively mitigate NCTH during a prolonged pre-hospital period with correctable metabolic an ...[more]

PMID: 33206692

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Project description:Introduction:Major trauma is a leading cause of death and disability in young adults, especially from massive non-compressible torso haemorrhage. The standard technique to control distal haemorrhage and maximise central perfusion is resuscitative thoracotomy with aortic cross-clamping (RTACC). More recently, the minimally invasive technique of resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed to similarly limit distal haemorrhage without the morbidity of thoracotomy; cost-utility studies on this intervention, however, are still lacking. The aim of this study was to perform a one-year cost-utility analysis of REBOA as an intervention for patients with major traumatic non-compressible abdominal haemorrhage, compared to RTACC within the U.K.'s National Health Service. Methods:A retrospective analysis of the outcomes following REBOA and RTACC was conducted based on the published literature of survival and complication rates after intervention. Utility was obtained from studies that used the EQ-5D index and from self-conducted surveys. Costs were calculated using 2016/2017 National Health Service tariff data and supplemented from further literature. A cost-utility analysis was then conducted. Results:A total of 12 studies for REBOA and 20 studies for RTACC were included. The mean injury severity scores for RTACC and REBOA were 34 and 39, and mean probability of death was 9.7 and 54%, respectively. The incremental cost-effectiveness ratio of REBOA when compared to RTACC was £44,617.44 per quality-adjusted life year. The incremental cost-effectiveness ratio, by exceeding the National Institute for Health and Clinical Effectiveness's willingness-to-pay threshold of £30,000/quality-adjusted life year, suggests that this intervention is not cost-effective in comparison to RTACC. However, REBOA yielded a 157% improvement in utility with a comparatively small cost increase of 31.5%. Conclusion:Although REBOA has not been found to be cost-effective when compared to RTACC, ultimately, clinical experience and expertise should be the main factor in driving the decision over which intervention to prioritise in the emergency context.

Project description:BackgroundControl of massive hemorrhage from penetrating wound sites is difficult in both combat and civilian settings. A new hemostatic dressing, sodium polyacrylate (PAAs)-based bag (PB), based on PAAs is designed for the first aid of massive penetrating hemorrhage. This study aimed to investigate the efficacy of PB in a penetrating trauma model in swine.MethodsA complex groin penetrating injury was produced in swine by completely excising the femoral vessels and surrounding muscles. After 15-second free bleeding, 18 healthy Guizhou female swine were administered PB (n = 6), CELOX-A (n = 6; Medtrade Products, Crewe, United Kingdom), or standard gauze (n = 6) for hemostatic intervention, followed by 3-minute compression if the bleeding persisted, with subsequent observation continuing for 1 hour. The primary outcomes included initial hemostasis, the incidence of applying manual pressure, and application time.ResultsSodium polyacrylate could rapidly absorb the liquid to expand, crosslink with a large number of red blood cells, induce cellular morphological alteration, and promote blood coagulation. Sodium polyacrylate-based bag and CELOX-A initiated and sustained hemostasis for 60 minutes, whereas 0% of the standard gauze achieved initial hemostasis. Maximum number of manual compressions were applied in standard gauze (6 of 6 [100%]), followed by CELOX-A (5 of 6 [80%]), while no manual pressure was required in the case of PB (0 of 6 [0%]). Application time for PB (19.0 ± 4.6 seconds) was significantly less than CELOX-A (169.0 ± 73.5 seconds) and standard gauze (187.8 ± 1.7 seconds).ConclusionWe prepared a type of superabsorbent PAAs and made an original hemostatic dressing, PB. It can rapidly achieve durable hemostasis in the groin-penetrating trauma hemorrhage swine model without any external compression. The packet form makes PB easy to deploy and remove from wounds. Therefore, PB could be a promising hemostatic candidate for controlling penetrating hemorrhage.

Project description:In combat operations, patients with traumatic injuries require expeditious evacuation to improve survival. Studies have shown that long transport times are associated with increased morbidity and mortality. Limited data exist on the influence of transport time on patient outcomes with specific injury types. The objective of this study was to determine the impact of the duration of time from the initial request for medical evacuation to arrival at a medical treatment facility on morbidity and mortality in casualties with traumatic extremity amputation and non-compressible torso injury (NCTI).We completed a retrospective review of MEDEVAC patient care records for United States military personnel who sustained traumatic amputations and NCTI during Operation Enduring Freedom between January 2011 and March 2014. We grouped patients as traumatic amputation and NCTI (AMP+NCTI), traumatic amputation only (AMP), and neither AMP nor NCTI (Non-AMP/NCTI). Analysis was performed using chi-squared tests, Fisher's exact tests, Cochran-Armitage Trend tests, Shapiro-Wilks tests, Wilcoxon and Kruskal-Wallis techniques and Cox proportional hazards regression modeling.We reviewed 1267 records, of which 669 had an injury severity score (ISS) of 10 or greater and were included in the analysis. In the study population, 15.5% sustained only amputation injuries (n=104, AMP only), 10.8% sustained amputation and NCTI (n=72, AMP+NCTI), and 73.7% did not sustain either an amputation or an NCTI (n=493, Non-AMP/NCTI). AMP+NCTI had the highest mortality (16.7%) with transport time greater than 60 min. While the AMP+NCTI group had decreasing survival with longer transport times, AMP and Non-AMP/NCTI did not exhibit the same trend.A decreased transport time from the point of injury to a medical treatment facility was associated with decreased mortality in patients who suffered a combination of amputation injury and NCTI. No significant association between transport time and outcomes was found in patients who did not sustain NCTI. Priority for rapid evacuation of combat casualties should be given to those with NCTI.

Dataset Information

Novel use of XSTAT 30 for mitigation of lethal non-compressible torso hemorrhage in swine.

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Novel use of XSTAT 30 for mitigation of lethal non-compressible torso hemorrhage in swine.

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