title: The iTClamp controls junctional bleeding in a lethal swine exsanguination model.
abstract: OBJECTIVE
  Severe hemorrhage is a leading cause of death and difficult to control even by trained medical personnel. Current interventions have significant limitations in the prehospital setting; therefore, a need exists for a new and effective treatment. iTraumaCare has designed a temporary wound closure device, the iTClamp, which controls external hemorrhage from open wounds within compressible zones. The device approximates the wound edges, sealing the skin within a pressure bar, enabling creation of a hematoma and subsequent clot formation. The objective of this study is to test the effectiveness of the iTClamp to control external bleeding due to a major vascular injury to the groin in an in vivo swine model.
  
  
  METHODS
  Twenty Yorkshire-cross male swine were enrolled in this study. A complex groin injury was created by complete excision of the femoral artery and vein along with some surrounding muscle. The animals were divided into four treatment groups: control (no treatment), early iTClamp treatment, late iTClamp treatment, and standard gauze treatment. Survival rate, survival time, and blood loss were the primary endpoints. Physiologic parameters (heart rate, blood pressure, oxygen saturation) were monitored throughout the experiment and blood samples were collected to analyze partial thromboplastin time and fibrinogen.
  
  
  RESULTS
  All (100%) of the animals treated with the iTClamp lived through the end of the experiment, compared to 60% in standard gauze treated and 0% of untreated control animals (early and late iTClamp vs. control and standard gauze, Fisher's exact, p = 0.003). Both the early iTClamp and late iTClamp treatment groups survived significantly longer than the untreated control pigs (Mann-Whitney U-test, p < 0.009). External blood loss was significantly lower in animals treated with the iTClamp (early) compared to no treatment (Mann-Whitney U-test, p < 0.008). There was no significant change in physiologic or hematologic parameters between treatment groups.
  
  
  CONCLUSIONS
  The iTClamp showed statistically significant improvement in survival, survival time, and estimated blood loss when compared to no treatment. This proof-of-concept study demonstrates the potential of the iTClamp to control severe bleeding and prevent blood loss.
authors: Innovative Trauma Care, Inc., Edmonton, Alberta, Canada. dfilips@itraumacare.com
authors: Dennis
authors: D
authors: Filips
authors: Sarvesh
authors: S
authors: Logsetty
authors: Jonathan
authors: J
authors: Tan
authors: Ian
authors: I
authors: Atkinson
authors: Kelly
authors: K
authors: Mottet
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D058734:Exsanguination; D006470:Hemorrhage / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D008297:Male; D013552:Swine
references: J Trauma. 2006 Jun;60(6 Suppl):S3-11
references: 16763478
references: J Trauma. 2006 Mar;60(3):655-8
references: 16531872
references: Lancet. 2010 Jul 3;376(9734):23-32
references: 20554319
references: Mil Med. 2005 Jan;170(1):63-9
references: 15724857
references: Ann Surg. 2009 Jan;249(1):1-7
references: 19106667
references: J Trauma. 2011 Nov;71(5 Suppl 1):S401-7
references: 22071995
references: Prehosp Emerg Care. 2007 Apr-Jun;11(2):172-8
references: 17454803
references: Surg Clin North Am. 1997 Aug;77(4):761-77
references: 9291979
references: Prehosp Emerg Care. 2007 Jan-Mar;11(1):67-71
references: 17169881
references: BMJ. 2009 Jun 05;338:b1778
references: 19502278
references: World J Surg. 2007 Nov;31(11):2092-103
references: 17899256
references: Crit Care. 2005;9 Suppl 5:S1-9
references: 16221313
references: US Army Med Dep J. 2011 Apr-Jun;:25-37
references: 21607904
references: J Trauma. 1995 Feb;38(2):185-93
references: 7869433
references: J Emerg Med. 2011 Dec;41(6):590-7
references: 19717268
references: J Trauma. 2009 Oct;67(4):848-55
references: 19820595
references: J Trauma. 2011 Nov;71(5 Suppl 1):S427-34
references: 22071999
references: Can J Surg. 2011 Dec;54(6):S118-23
references: 22099324
references: J Trauma. 2008 Apr;64(4):1093-9
references: 18404080
references: J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7
references: 23192066
references: Mil Med. 2010 Apr;175(4):280-4
references: 20446504
references: Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2
references: 21439633
references: J Trauma. 2009 Feb;66(2):316-26; discussion 327-8
references: 19204503
references: Ann Surg. 2007 Jun;245(6):986-91
references: 17522526
references: Eur J Vasc Endovasc Surg. 2012 Aug;44(2):203-9
references: 22658774
references: J Trauma. 2011 Jun;70(6):1413-9
references: 21817978
references: Acad Emerg Med. 2011 Apr;18(4):340-50
references: 21496135
references: J Emerg Med. 2009 Jul;37(1):1-7
references: 18024069
references: US Army Med Dep J. 2011 Apr-Jun;:38-48
references: 21607905
references: J Trauma. 2011 Jul;71(1 Suppl):S4-8
references: 21795876
references: J Am Coll Surg. 1998 May;186(5):528-33
references: 9583692
references: J Trauma. 2008 Feb;64(2 Suppl):S21-6; discussion S26-7
references: 18376168
references: Am J Vet Res. 1996 Apr;57(4):529-34
references: 8712520
references: J Trauma. 2005 Oct;59(4):865-74; discussion 874-5
references: 16374275
references: J Trauma. 2004 May;56(5):974-83
references: 15179235
references: Arch Surg. 1994 Jan;129(1):39-45
references: 8279939
references: J Trauma. 2004 Aug;57(2):224-30
references: 15345965
references: J Surg Res. 2011 Jul;169(1):92-8
references: 20070980
references: Prehosp Emerg Care. 2011 Oct-Dec;15(4):477-82
references: 21870945
references: J Trauma. 2003 Jun;54(6):1077-82
references: 12813325
references: Mil Med. 2012 Sep;177(9):1065-8
references: 23025136