Long-term preclinical evaluation of the intracorporeal use of advanced local hemostatics in a damage-control swine model of grade IV liver injury

Kenji Inaba, Bernardino C. Branco, Peter M Rhee, Bradley Putty, Obi Okoye, Galinos Barmparas, Peep Talving, Demetrios Demetriades

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

BACKGROUND: The purpose of this study was to evaluate the long-term efficacy and safety of kaolin-and chitosan-based hemostatic agents for hemorrhage control in a 14-day survival, damage-control swine model of Grade IV liver injury. METHODS: A total of 48 anesthetized pigs (40 kg) underwent a 35% total blood volume bleed, cooling to 34-C and a standardized liver injury. The animals were randomized to standard gauze control (SG, n = 12), QuikClot Combat Gauze (QCCG, n = 12), Celox (CX, n = 12), or Celox Gauze (CXG, n = 12) packing. At 15 minutes, shed blood was calculated, followed by damage-control closure. At 48 hours, pack removal and definitive closure was performed. At 14-day sacrifice, the liver, kidney, heart, lung, and small bowel standard intraabdominal organs were sampled for histopathological examination. RESULTS: Uncontrolled blood loss at 2 minutes demonstrated internal consistency of the injury. Blood loss at 15 minutes was significantly lower in the CX and QCCG arms (SG, 11.1 ± 1.1 mL/kg; QCCG, 5.3 ± 1.2 mL/kg; CX, 5.7 ± 1.2 mL/kg; and CXG, 10.1 ± 1.3 mL/kg; p = 0.002). Forty-eightYhour survival was 50.0% for SG, 58.3% for QCCG, 83.3% for CX, and 41.7% for CXG (p = 0.161). Fourteenday survival was 41.7% (5) for SG, 50.0% (6) for QCCG, 58.3% (7) for CX, and 41.7% (5) for CXG (p = 0.821). Four CX and two QCCG deaths were caused by bowel obstruction; one SG death was caused by sepsis; the remainder was caused by blood loss. Histopathology in one CX animal demonstrated eosinophilic material within a coronary vessel consistent with granule embolization. CONCLUSION: Celox and QuikClot Combat Gauze were effective hemostatic adjuncts to standard intracavitary damage-control packing. The hemostasis was durable, facilitating pack removal, and definitive closure at reoperation. There was however an increase in the development of intra-abdominal adhesions resulting in small bowel obstruction. The potential for distant embolization of granular agents warrants further investigation.

Original languageEnglish (US)
Pages (from-to)538-545
Number of pages8
JournalJournal of Trauma and Acute Care Surgery
Volume74
Issue number2
DOIs
StatePublished - Feb 2013

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Hemostatics
Swine
Liver
Wounds and Injuries
Kaolin
Chitosan
Blood Volume
Hemostasis
Reoperation
Sepsis
Coronary Vessels
Hemorrhage
Kidney
Safety
Lung
Celox

Keywords

  • Damage control
  • Hemostatic
  • Liver
  • Long-term
  • Topical

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Surgery

Cite this

Long-term preclinical evaluation of the intracorporeal use of advanced local hemostatics in a damage-control swine model of grade IV liver injury. / Inaba, Kenji; Branco, Bernardino C.; Rhee, Peter M; Putty, Bradley; Okoye, Obi; Barmparas, Galinos; Talving, Peep; Demetriades, Demetrios.

In: Journal of Trauma and Acute Care Surgery, Vol. 74, No. 2, 02.2013, p. 538-545.

Research output: Contribution to journalArticle

Inaba, Kenji ; Branco, Bernardino C. ; Rhee, Peter M ; Putty, Bradley ; Okoye, Obi ; Barmparas, Galinos ; Talving, Peep ; Demetriades, Demetrios. / Long-term preclinical evaluation of the intracorporeal use of advanced local hemostatics in a damage-control swine model of grade IV liver injury. In: Journal of Trauma and Acute Care Surgery. 2013 ; Vol. 74, No. 2. pp. 538-545.
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abstract = "BACKGROUND: The purpose of this study was to evaluate the long-term efficacy and safety of kaolin-and chitosan-based hemostatic agents for hemorrhage control in a 14-day survival, damage-control swine model of Grade IV liver injury. METHODS: A total of 48 anesthetized pigs (40 kg) underwent a 35{\%} total blood volume bleed, cooling to 34-C and a standardized liver injury. The animals were randomized to standard gauze control (SG, n = 12), QuikClot Combat Gauze (QCCG, n = 12), Celox (CX, n = 12), or Celox Gauze (CXG, n = 12) packing. At 15 minutes, shed blood was calculated, followed by damage-control closure. At 48 hours, pack removal and definitive closure was performed. At 14-day sacrifice, the liver, kidney, heart, lung, and small bowel standard intraabdominal organs were sampled for histopathological examination. RESULTS: Uncontrolled blood loss at 2 minutes demonstrated internal consistency of the injury. Blood loss at 15 minutes was significantly lower in the CX and QCCG arms (SG, 11.1 ± 1.1 mL/kg; QCCG, 5.3 ± 1.2 mL/kg; CX, 5.7 ± 1.2 mL/kg; and CXG, 10.1 ± 1.3 mL/kg; p = 0.002). Forty-eightYhour survival was 50.0{\%} for SG, 58.3{\%} for QCCG, 83.3{\%} for CX, and 41.7{\%} for CXG (p = 0.161). Fourteenday survival was 41.7{\%} (5) for SG, 50.0{\%} (6) for QCCG, 58.3{\%} (7) for CX, and 41.7{\%} (5) for CXG (p = 0.821). Four CX and two QCCG deaths were caused by bowel obstruction; one SG death was caused by sepsis; the remainder was caused by blood loss. Histopathology in one CX animal demonstrated eosinophilic material within a coronary vessel consistent with granule embolization. CONCLUSION: Celox and QuikClot Combat Gauze were effective hemostatic adjuncts to standard intracavitary damage-control packing. The hemostasis was durable, facilitating pack removal, and definitive closure at reoperation. There was however an increase in the development of intra-abdominal adhesions resulting in small bowel obstruction. The potential for distant embolization of granular agents warrants further investigation.",
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AU - Branco, Bernardino C.

AU - Rhee, Peter M

AU - Putty, Bradley

AU - Okoye, Obi

AU - Barmparas, Galinos

AU - Talving, Peep

AU - Demetriades, Demetrios

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N2 - BACKGROUND: The purpose of this study was to evaluate the long-term efficacy and safety of kaolin-and chitosan-based hemostatic agents for hemorrhage control in a 14-day survival, damage-control swine model of Grade IV liver injury. METHODS: A total of 48 anesthetized pigs (40 kg) underwent a 35% total blood volume bleed, cooling to 34-C and a standardized liver injury. The animals were randomized to standard gauze control (SG, n = 12), QuikClot Combat Gauze (QCCG, n = 12), Celox (CX, n = 12), or Celox Gauze (CXG, n = 12) packing. At 15 minutes, shed blood was calculated, followed by damage-control closure. At 48 hours, pack removal and definitive closure was performed. At 14-day sacrifice, the liver, kidney, heart, lung, and small bowel standard intraabdominal organs were sampled for histopathological examination. RESULTS: Uncontrolled blood loss at 2 minutes demonstrated internal consistency of the injury. Blood loss at 15 minutes was significantly lower in the CX and QCCG arms (SG, 11.1 ± 1.1 mL/kg; QCCG, 5.3 ± 1.2 mL/kg; CX, 5.7 ± 1.2 mL/kg; and CXG, 10.1 ± 1.3 mL/kg; p = 0.002). Forty-eightYhour survival was 50.0% for SG, 58.3% for QCCG, 83.3% for CX, and 41.7% for CXG (p = 0.161). Fourteenday survival was 41.7% (5) for SG, 50.0% (6) for QCCG, 58.3% (7) for CX, and 41.7% (5) for CXG (p = 0.821). Four CX and two QCCG deaths were caused by bowel obstruction; one SG death was caused by sepsis; the remainder was caused by blood loss. Histopathology in one CX animal demonstrated eosinophilic material within a coronary vessel consistent with granule embolization. CONCLUSION: Celox and QuikClot Combat Gauze were effective hemostatic adjuncts to standard intracavitary damage-control packing. The hemostasis was durable, facilitating pack removal, and definitive closure at reoperation. There was however an increase in the development of intra-abdominal adhesions resulting in small bowel obstruction. The potential for distant embolization of granular agents warrants further investigation.

AB - BACKGROUND: The purpose of this study was to evaluate the long-term efficacy and safety of kaolin-and chitosan-based hemostatic agents for hemorrhage control in a 14-day survival, damage-control swine model of Grade IV liver injury. METHODS: A total of 48 anesthetized pigs (40 kg) underwent a 35% total blood volume bleed, cooling to 34-C and a standardized liver injury. The animals were randomized to standard gauze control (SG, n = 12), QuikClot Combat Gauze (QCCG, n = 12), Celox (CX, n = 12), or Celox Gauze (CXG, n = 12) packing. At 15 minutes, shed blood was calculated, followed by damage-control closure. At 48 hours, pack removal and definitive closure was performed. At 14-day sacrifice, the liver, kidney, heart, lung, and small bowel standard intraabdominal organs were sampled for histopathological examination. RESULTS: Uncontrolled blood loss at 2 minutes demonstrated internal consistency of the injury. Blood loss at 15 minutes was significantly lower in the CX and QCCG arms (SG, 11.1 ± 1.1 mL/kg; QCCG, 5.3 ± 1.2 mL/kg; CX, 5.7 ± 1.2 mL/kg; and CXG, 10.1 ± 1.3 mL/kg; p = 0.002). Forty-eightYhour survival was 50.0% for SG, 58.3% for QCCG, 83.3% for CX, and 41.7% for CXG (p = 0.161). Fourteenday survival was 41.7% (5) for SG, 50.0% (6) for QCCG, 58.3% (7) for CX, and 41.7% (5) for CXG (p = 0.821). Four CX and two QCCG deaths were caused by bowel obstruction; one SG death was caused by sepsis; the remainder was caused by blood loss. Histopathology in one CX animal demonstrated eosinophilic material within a coronary vessel consistent with granule embolization. CONCLUSION: Celox and QuikClot Combat Gauze were effective hemostatic adjuncts to standard intracavitary damage-control packing. The hemostasis was durable, facilitating pack removal, and definitive closure at reoperation. There was however an increase in the development of intra-abdominal adhesions resulting in small bowel obstruction. The potential for distant embolization of granular agents warrants further investigation.

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