Thermoreversible Reverse-Phase-Shift Foam for Treatment of Noncompressible Torso Hemorrhage

Donaldson, Ross I.; Zimmermann, Eric; Fisher, Timothy C. G.; Buchanan, Oliver J; Armstrong, Jonathan K.; Cambridge, John; Graham, Todd L.; Ross, James D.

doi:10.1016/j.jss.2020.11.039

Cited by 8 publications

(7 citation statements)

References 35 publications

(39 reference statements)

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“…These animals included both published and unpublished work. 4,30,31 From these data, we found the mean baseline SBP of these animals to be 90 (7) mmHg. Therefore, we calculated the permissive hypotension resuscitation SBP target for our animal model to be 67 mm Hg (i.e., a 25% decrease from 90 mm Hg).…”

Section: Calculation Of Permissive Hypotension Targetmentioning

confidence: 75%

“…All swine that were in the same weight range (40–60 kg), had identical preexperimental handling and induction, and a minimum of two invasive vascular access procedures were included in the analysis (n = 70). These animals included both published and unpublished work 4,30,31 . From these data, we found the mean baseline SBP of these animals to be 90 (7) mmHg.…”

Section: Methodsmentioning

confidence: 90%

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Efficacy of past, present, and future fluid strategies in an improved large animal model of non-compressible intra-abdominal hemorrhage

Donaldson¹,

Graham²,

Fisher³

et al. 2021

J Trauma Acute Care Surg

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BACKGROUND: Noncompressible hemorrhage is a leading cause of potentially survivable combat death, with the vast majority of such deaths occurring in the out-of-hospital environment. While large animal models of this process are important for device and therapeutic development, clinical practice has changed over time and past models must follow suit. Developed in conjunction with regulatory feedback, this study presents a modernized, out-of-hospital, noncompressible hemorrhage model, in conjunction with a randomized study of past, present, and future fluid options following a hypotensive resuscitation protocol consistent with current clinical practice. METHODS:We performed a randomized controlled experiment comparing three fluid resuscitation options in Yorkshire swine. Baseline data from animals of same size from previous experiments were analyzed (n = 70), and mean systolic blood pressure was determined, with a permissive hypotension resuscitation target defined as a 25% decrease from normal (67 mm Hg). After animal preparation, a grade IV to V liver laceration was induced. Animals bled freely for a 10-minute "time-to-responder" period, after which resuscitation occurred with randomized fluid in boluses to the goal target: 6% hetastarch in lactated electrolyte injection (HEX), normal saline (NS), or fresh whole blood (FWB). Animals were monitored for a total simulated "delay to definitive care" period of 2 hours postinjury. RESULTS:At the end of the 2-hour study period, 8.3% (1 of 12 swine) of the HEX group, 50% (6 of 12 swine) of the NS group, and 75% (9 of 12 swine) of the FWB had survived (p = 0.006), with Holm-Sidak pairwise comparisons showing a significant difference between HEX and FWB and (p = 0.005). Fresh whole blood had significantly higher systemic vascular resistance and hemoglobin levels compared with other groups (p = 0.003 and p = 0.001, respectively). CONCLUSION: Survival data support the movement away from HEX toward NS and, preferably, FWB in clinical practice and translational animal modeling. The presented model allows for future research including basic science, as well as translational studies of novel diagnostics, therapeutics, and devices.

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Section: Calculation Of Permissive Hypotension Targetmentioning

confidence: 75%

Section: Methodsmentioning

confidence: 90%

Efficacy of past, present, and future fluid strategies in an improved large animal model of non-compressible intra-abdominal hemorrhage

Donaldson¹,

Graham²,

Fisher³

et al. 2021

J Trauma Acute Care Surg

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“…124 The current treatment involves operative intervention, while the probability of death increases by approximately 1% for each 3 min delay to surgery. 125 Hemostatic biomaterials are thus under critical demand for pre-hospital hemorrhage control at point-of-injury or during transport, where the hemostatic agents are expected to be storable, easily administrated even by a layperson under austere conditions, and effectively control bleeding before further definitive management. 126 Intraoperatively, the hemostatic biomaterials are used as an adjunct or alternative to standard surgical techniques, including electrocautery, vessel ligation, and suturing.…”

Section: Discussion and Outlookmentioning

confidence: 99%

Hemostatic biomaterials to halt non-compressible hemorrhage

et al. 2022

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“…A medical device company (Critical Innovations LLC) is developing a new device, Fast Onset Abdominal Management (FOAM), that delivers a self-expanding, intraperitoneal deployed, thermoreversible agent. 10 FOAM is designed to be transported and administered by medics with minimal training ( Fig. 1A ).…”

Section: Introductionmentioning

confidence: 99%

“…When deployed, FOAM provides pressure throughout the peritoneal cavity to quickly tamponade NCTH and has been shown to significantly improve mean arterial pressures in a short-term animal efficacy model of surgically induced grade IV liver laceration. 10 The purpose of this pilot study was to assess the long-term safety and physical characteristics of FOAM deployment in noninjured swine. Specifically, the study explored the ability to clear intraperitoneal deployed agent as well as the effects of increased intra-abdominal pressure generated by the FOAM system on abdominal organs.…”

Section: Introductionmentioning

confidence: 99%

Thermoreversible Reverse-Phase-Shift Foam for Treatment of Noncompressible Torso Hemorrhage, a Safety Trial in a Porcine Model

et al. 2022

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Introduction Noncompressible torso hemorrhage is the leading cause of exsanguination on the battlefield. A self-expanding, intraperitoneal deployed, thermoreversible foam has been developed that can be easily administered by a medic in austere settings to temporarily tamponade noncompressible torso hemorrhage. The purpose of this study was to assess the long-term safety and physical characteristics of using Fast Onset Abdominal Management (FOAM; Critical Innovations LLC) in swine. Materials and Methods Yorkshire swine (40-60 kg) were sedated, intubated, and placed on ventilatory support. An external jugular catheter was placed for sampling of blood. Continuous heart rate, temperature, saturation of peripheral oxygen, end-tidal carbon dioxide, and peak airway pressures were monitored for a 4-hour period after intervention (i.e., FOAM agent injection or a sham introducer without agent delivery). The FOAM agent was injected to obtain an intra-abdominal pressure of 60 mmHg for at least 10 minutes. After 4 hours, the animals were removed from ventilatory support and returned to their housing for a period of 7-14 days. Group size analysis was not performed, as this was a descriptive safety study. Blood samples were obtained at baseline and at 1-hour post-intervention and then on days 1, 3, 7, and 14. Euthanasia, necropsy, and harvesting of samples for histologic analysis (from kidneys, terminal ilium, liver, pancreas, stomach, spleen, and lungs) were performed upon expiration. Histologic scoring for evidence of ischemia, necrosis, and abdominal compartment sequela was blinded and reported by semi-quantitative scale (range 0-4; 0 = no change, 1 = minimal, 2 = mild, 3 = moderate, and 4 = marked). Oregon Health & Science University’s Institutional Animal Care and Use Committee, as well as the U.S. Army Animal Care and Use Review Office, approved this protocol before the initiation of experiments (respectively, protocol numbers IP00003591 and MT180006.e002). Results Five animals met a priori inclusion criteria, and all of these survived to their scheduled endpoints. Two animals received sham injections of the FOAM agent (one euthanized on day 7 and one on day 14), and three animals received FOAM agent injections (one euthanized on day 7 and two on day 14). A transitory increase in creatinine and lactate was detected during the first day in the FOAM injected swine but resolved by day 3. No FOAM agent was observed in the peritoneal cavity upon necropsy at day 7 or 14. Histologic data revealed no clinically relevant differences in any organ system between intervention and control animals upon sacrifice at day 7 or 14. Conclusions This study describes the characteristics, survival, and histological analysis of using FOAM in a porcine model. In our study, FOAM reached the desired intra-abdominal pressure endpoint while not significantly altering basic hematologic parameters, except for transient elevations of creatinine and lactate on day 1. Furthermore, there was no clinical or histological relevant evidence of ischemia, necrosis, or intra-abdominal compartment syndrome. These results provide strong support for the safety of the FOAM device and will support the design of further regulatory studies in swine and humans.

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Thermoreversible Reverse-Phase-Shift Foam for Treatment of Noncompressible Torso Hemorrhage

Cited by 8 publications

References 35 publications

Efficacy of past, present, and future fluid strategies in an improved large animal model of non-compressible intra-abdominal hemorrhage

Efficacy of past, present, and future fluid strategies in an improved large animal model of non-compressible intra-abdominal hemorrhage

Hemostatic biomaterials to halt non-compressible hemorrhage

Thermoreversible Reverse-Phase-Shift Foam for Treatment of Noncompressible Torso Hemorrhage, a Safety Trial in a Porcine Model

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