Studies on the Efficacy of Hemostatic Agents

## Hemorrhage Control Studies:

Management of External Hemorrhage in Tactical Combat Casualty Care: The Adjunctive Use of XStat™ Compressed Hemostatic Sponges. TCCC Guidelines: Change 15-03.

Kyle Sims; F. Bowling, Harold Montgomery, Paul Dituro; Bijan S. Kheirabadi, PhD, Frank Butler, MD

Journal of Special Operations Medicine

J Spec Oper Med. 2016 Spring;16(1):19-28

Management of External Hemorrhage in Tactical Combat Casualty Care: Chitosan-Based Hemostatic Gauze Dressings. TCCC Guidelines – Change 13-05.

Brad L. Bennett, PhD, NREMT-P; Lanny F. Littlejohn, MD; Bijan S. Kheirabadi, PhD;

Frank K. Butler, MD; Russ S. Kotwal, MD; Michael A. Dubick, PhD; Jeffrey A. Bailey, MD

Journal of Special Operations Medicine

J Spec Oper Med. 2014 Fall;14(3):40-57

Comparison of novel hemostatic gauzes to QuikClot Combat Gauze in a standardized swine model of uncontrolled hemorrhage.

Jason M. Rall, PhD, Jennifer M. Cox, BS, Adam G. Songer, MD, Ramon F. Cestero, MD,

and James D. Ross, PhD

Journal of Trauma Acute Care Surgery

J Trauma Acute Care Surg. 2013; 75(2 Suppl 2):S150-6.

Hemostasis in a noncompressible hemorrhage model: An end-user evaluation of hemostatic agents in a proximal arterial injury.

Steven Satterly, MD, Daniel Nelson, DO, Nathan Zwintscher, MD, Morohunranti Oguntoye, MD, Wayne Causey, MD, Bryan Theis, BS, Raywin Huang, PhD, Mohamad Haque, MD,

Matthew Martin, MD, J Gerald Bickett EMT, and Robert M. Rush Jr, MD

Journal of Surgical Education

J Surg Educ. 2013;70(2):206-11.

Advanced hemostatic dressings are not superior to gauze for care under fire scenarios.

Jennifer M. Watters, MD, Philbert Y. Van, MD, Gregory J. Hamilton, BS, Chitra Sambasivan, MD, Jerome A. Differding, MPH, and Martin A. Schreiber, MD

Journal of TRAUMA Injury, Infection, and Critical Care

J Trauma 2011;70:1413-18.

Comparison of two packable hemostatic Gauze dressings in a porcine hemorrhage model.

Richard Bruce Schwartz MD, Bradford Zahner Reynolds MD, Stephen A. Shiver MD, E. Brooke Lerner PhD, Eric Mark Greenfield DO, Ricaurte A. Solis DO, Nicholas A. Kimpel DO, Phillip L. Coule MD & John G. McManus MD

Prehospital Emergency Care

Prehosp Emerg Care 2011;15:477-482

#### Description with Key Points:

A synthesis of studies performed to evaluate the efficacy of the various hemostatic agents available at the point of injury show that they all perform equally.

#### Key Point 1

Novel hemostatic devices (QuikClot Combat Gauze, QuikClot Combat Gauze XL, Celox Trauma Gauze, Celox Gauze, or HemCon ChitoGauze) perform at least as well as the current Committee on Tactical Combat Casualty Care standard for point-of-injury hemorrhage control. Despite their different compositions and sizes, the lack of clear superiority of any agent suggests that contemporary hemostatic dressing technology has potentially reached a plateau for efficacy.

#### Key Point 2

There is no significant difference in hemostasis between hemostatic bandages for proximal arterial hemorrhage. Hemostasis significantly improves between 2 and 4 minutes using direct pressure and hemostatic agents. Prior medical training leads to 20% greater efficacy when using hemostatic dressings.

#### Key Point 3

ChitoGauze and CombatGauze appear to be equally efficacious in their hemostatic properties, as demonstrated in a porcine hemorrhage model.

#### Key Point 4

XStat (a non-absorbable, expandable, hemostatic sponge) is a new product recently approved by the FDA as a hemostatic adjunct to aid in the control of bleeding from junctional wounds in the groin or axilla. XStat is a new option for the control of external hemorrhage from junctional bleeding sites that are not adequately addressed by tourniquets, Combat gauze, Celox gauze, Chitogauze, Combat Ready Clamp, Junctional Emergency Treatment Tool, or the SAM Junctional Tourniquet.

## Take Home Message:

Rapid hemorrhage control is crucial for survival since uncontrolled hemorrhage remains the primary cause of preventable battlefield mortality and a significant cause of domestic civilian mortality. Hemostatic dressings are another tool that should be used at the point of injury.
The CoTCCC recommends QuikClot Combat Gauze as the hemostatic dressing of choice due to its ease of training and use along with its proven efficacy.
Celox Gauze and ChitoGauze are as effective as Combat Gauze at hemorrhage control in laboratory studies and may be used.
Neither ChitoGauze nor Celox Gauze have been tested in the USAISR safety model, but Chitosan-based hemostatic dressings have been used in combat since 2004 with no safety issues reported.
Studies have shown there is no significant difference in hemostasis between hemostatic bandages (Combat Gauze, Celox Gauze, and ChitoGauze).
XStat is recommended by the CoTCCC as yet another tool for the combat medical provider to use in the management of junctional hemorrhage.