Percutaneous delivery of self-propelling hemostatic powder for managing non-compressible abdominal hemorrhage: a proof-of-concept study in swine

Cau, Massimo F.; Ali-Mohamad, Nabil; Baylis, James R.; Zenova, Veronika; Khavari, Adele; Peng, Noah; McFadden, Andrew; Donnellan, Fergal; Owen, Daniel R.; Schaeffer, David F.; Nagaswami, Chandrasekaran; Litvinov, Rustem I.; Weisel, John W.; Rezende-Neto, João; Semple, Hugh A.; Beckett, Andrew; Kastrup, Christian J.

doi:10.1016/j.injury.2022.01.024

Cited by 9 publications

(25 citation statements)

References 48 publications

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“…This injury model had low variability and was universally fatal in control animals, consistent with similar models, 24 which made it appropriate for determining the survival benefit of SPTP. Furthermore, the improved spray device used in this study led to a faster intervention time for the SPTP system (4 minutes vs. 12 minutes 17 ), which likely contributed to increased bulk dispersion of SPTP and affected survival. Previous hemostatic foams containing fibrinogen, factor XIII, and thrombin were only effective in small animal, open abdomen models 34,35 .…”

Section: Discussionmentioning

confidence: 98%

“…After closing the laparotomy, the Focused Assessment with Sonography in Trauma (FAST) exam (C3 HD Convex Scanner; Clarius, Burnaby, Canada) was performed to identify hemoperitoneum. The right upper quadrant containing the liver was checked first because this is the preferred initial site for the FAST examination, and this was also the expected location of the hemoperitoneum in this model of liver injury 17 . Self-propelling thrombin-containing powder was delivered into the center of the hemoperitoneum using the SPTP spray system, which consisted of the spray device and a 14-Fr pigtail catheter (catalog number G56535; Cook Medical, Bloomington, IN).…”

Section: Methodsmentioning

confidence: 99%

“…The right upper quadrant containing the liver was checked first because this is the preferred initial site for the FASTexamination, and this was also the expected location of the hemoperitoneum in this model of liver injury. 17 Self-propelling thrombin-containing powder was delivered into the center of the hemoperitoneum using the SPTP spray system, which consisted of the spray device and a 14-Fr pigtail catheter (catalog number G56535; Cook Medical, Bloomington, IN). Ultrasound, catheter placement, and SPTP delivery were conducted in 3.8 ± 0.5 minutes.…”

Section: Sptp Spray System Interventionmentioning

confidence: 99%

“…CO 2 formation propels thrombin and TXA through large volumes of pooled blood within the abdomen, reaching wound sites to trigger coagulation, and locally inhibit fibrinolysis. In vivo proof of concept that SPTP could manage NCTH was demonstrated previously where a handheld spray device and catheter were deployed to deliver SPTP into the closed abdomen of swine 17 . Delivery of SPTP was well-tolerated physiologically and did not excessively increase intra-abdominal pressure (IAP).…”

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confidence: 99%

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Percutaneous delivery of self-propelling thrombin-containing powder increases survival from noncompressible truncal hemorrhage in a swine model of coagulopathy and hypothermia

Cau

Ali-Mohamad

Yeh

et al. 2022

J Trauma Acute Care Surg

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BACKGROUND: Noncompressible truncal hemorrhage (NCTH) remains a leading cause of preventable death on the battlefield. Definitively managing severe NCTH requires surgery within the first hour after injury, which is difficult when evacuating casualties from remote and austere environments. During delays to surgery, hemostatic interventions that are performed prehospital can prevent coagulopathy and hemorrhagic shock and increase the likelihood that casualties survive to receive definitive care. We previously reported that a self-propelling thrombin-containing powder (SPTP) can be delivered percutaneously into the abdomen as a minimally invasive intervention and can self-disperse through pooled blood to deliver the hemostatic agents thrombin and tranexamic acid locally to noncompressible intracavitary wounds. We hypothesized that, in swine with massive NCTH, dilutional coagulopathy, and hypothermia, delivering SPTP could extend survival times. METHODS:Ten swine (n = 5 per group) underwent NCTH from a Grade V liver injury following a midline laparotomy. The laparotomy was closed with sutures afterwards, creating a hemoperitoneum, and animals were managed with crystalloid fluid resuscitation, or crystalloid resuscitation and SPTP. Self-propelling thrombin-containing powder was delivered into the closed abdomen using a CO 2 -powered spray device and a catheter placed into the hemoperitoneum, entering through the upper right quadrant using the Seldinger technique. Survival to 1 and 3 hours was recorded. In an additional animal, hemorrhage was created laparoscopically, and SPTP was imaged in situ within the abdomen to visually track dispersion of the particles. RESULTS:Self-propelling thrombin-containing powder dispersed as far as 35 ± 5.0 cm within the abdomen. It increased survival to 1 and 3 hours (Kaplan-Meier p = 0.007 for both). The median survival time was 61 minutes with SPTP and 31 minutes without ( p = 0.016). CONCLUSION: Self-propelling thrombin-containing powder effectively disperses medications throughout a hemoperitoneum and increases survival in a model of NCTH. It is a promising strategy for nonsurgical management of NCTH, warranting further testing of its safety and efficacy.

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Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Sptp Spray System Interventionmentioning

confidence: 99%

mentioning

confidence: 99%

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Percutaneous delivery of self-propelling thrombin-containing powder increases survival from noncompressible truncal hemorrhage in a swine model of coagulopathy and hypothermia

Cau

Ali-Mohamad

Yeh

et al. 2022

J Trauma Acute Care Surg

Self Cite

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show abstract

“…Large animal models such as swine models are preferable, where more criteria such as the mean arterial pressure (MAP), heart rate, end tidal CO 2 (EtCO 2 ), blood coagulation panel parameters, and serum lactate concentrations can be used to determine the grade of hemorrhage and evaluate the hemostatic efficacy of biomaterials. 129…”

Section: Remaining Challengesmentioning

confidence: 99%