itclamp 50 Clinical Training M-115-CE Rev C

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1 itclamp 50 Clinical Training M-115-CE Rev C

2 Objectives Explain the impact of bleeding in trauma Recognize the importance of rapid haemorrhage control Classify wounds on the spectrum of bleeding Select appropriate intervention for type of bleeding Understand how itclamp fits into an overall haemorrhage control strategy

3 The Haemorrhage Problem Bleeding is the leading cause of preventable death in all types of traumatic injuries 1 Current research indicates stopping haemorrhage early is critical to good outcomes 1,2 25% of trauma patients arriving in the ED have established coagulopathy 2 1 Kauvar, D. et al, Impact of Hemorrhage on Trauma Outcome, J of Trauma; 2006; 60:s3-s11 2 Brohi, K et al, Acute Traumatic Coagulopathy, J Trauma; 2003; 54:

M-115-US Rev B The Haemorrhage Problem: A new USAISR study* finds that nearly 25% of the 4,596 combat deaths in

medical facility 91% of potentially survivable deaths were due to uncontrolled blood loss 90 13,50% 80 70 91 %

"Hemorrhage control, both control of torso hemorrhage and junctional hemorrhage are top research priorities Butler

4 M-115-US Rev B The Haemorrhage Problem: A new USAISR study* finds that nearly 25% of the 4,596 combat deaths in Iraq and Afghanistan between were "potentially survivable 87% of the deaths occur prior to reaching a medical facility 91% of potentially survivable deaths were due to uncontrolled blood loss 90 13,50% % 19,20% TRUNCAL ,30% JUNCTIONAL 40 EXTREMITY HEMORRHAGE AIRWAY OBSTRUCTION TENSION PNEUMOTHORAX "Hemorrhage control, both control of torso hemorrhage and junctional hemorrhage are top research priorities Butler told members of the Defense Health Board on June 25, Eastridge et al. J Trauma Acute Care Surg. 2012; 73 (S431-S437)

Rapid Extrication to safety 4. Assessment by medical providers 5.

5 Hartford Consensus Joint Committee to Create a National Policy to Enhance Survivability from Mass Casualty Shooting Events T H R E A T 1. Threat suppression 2. Hemorrhage control 3. Rapid Extrication to safety 4. Assessment by medical providers 5. Transport to definitive care 4 4 Jacobs, L. et al. The Hartford Consensus, J of American College of Surgeons (5),

6 Treatment Priorities Stop bleeding Prevent initiation of lethal triad Rapid transport to definitive care

8 Spectrum of Bleeding Wounds Minor wounds: Abrasion Superficial laceration Small puncture Gauze with temporary pressure is effective Care priorities: Stop bleeding Wound protection

$avulsions, punctures, open fractures) Muscle bleeding Junctional bleeds Arterial bleeds Care priorities: Stop bleeding Other life$

9 Spectrum of Bleeding Wounds Difficult to control bleeding: Scalp injuries Open wounds (e. g. avulsions, punctures, open fractures) Muscle bleeding Junctional bleeds Arterial bleeds Care priorities: Stop bleeding Other life threatening injuries Rapid transport

Scalp Lacerations Fatal Haemorrhage From Simple Lacerations of the Scalp 5 Frequent occurrence Even trivial lacerations of bloodrich areas such as the scalp may bleed profusely and persistently In

10 Scalp Lacerations Fatal Haemorrhage From Simple Lacerations of the Scalp 5 Frequent occurrence Even trivial lacerations of bloodrich areas such as the scalp may bleed profusely and persistently In one published report 5 shown to be the cause of death in multiple cases where it was not initially obvious. 5 Hamilton, J.P. et al. Fatal Hemorrhage from simple laceration Forensic Science Medicine 2005; 1(4):

11 Spectrum of Bleeding Wounds Traumatic amputations: Severe soft tissue and skeletal involvement Unable to approximate wound edges Both venous and arterial haemorrhage Care priorities: Stop bleeding Other life threatening injuries Rapid transport

12 Haemorrhage Control Interventions Utilize the most rapid and appropriate method for hemostasis: Direct pressure Gauze itclamp Haemostatic Agent Tourniquet Tranexamic Acid (TXA)

Standard gauze performs just as well as haemostatic gauze 6.

13 Direct Pressure / Gauze Pressure can be applied with or without gauze Continuous application of pressure and wound packing is the key factor in stopping bleeding, not the type of gauze 6. Standard gauze performs just as well as haemostatic gauze 6. 6 Littlejohn LF, et all, Comparison of Celox-A, ChitoFlex, WoundStat and combat gauze hemostatic agents versus standard gauze. Acad Emerg Med. 2011;18(4):340-50

14 Trauma Clamp itclamp Rapid application and haemorrhage control Cessation of blood flow at the point of injury in seconds Maintains distal flow Minimal pain

15 itclamp Mechanism of Action M-115-CE Rev C

itclamp: Evidence Life Threating haemorrhagic swine model 7 100 % treated with itclamp survived vs.

movement Clinical Use Ongoing data collection with clinical use has shown no failures or adverse outcomes 7 Filips, D., et al.

16 itclamp: Evidence Life Threating haemorrhagic swine model % treated with itclamp survived vs. 60 % with standard gauze Pre-clinical Cadaver Study % effective at controlling fluid loss in all compressible zones No change with patient movement Clinical Use Ongoing data collection with clinical use has shown no failures or adverse outcomes 7 Filips, D., et al. The itclamp controls junctional bleeding in a lethal swine exsanguination model. Prehospital Emergency Care; 2013; 17(4), Mottet, K. et al. Evaluation of the itclamp in a Human Cadaver Model. J of Trauma; March 2014; 76:3

Celox) Key ingredient chitosan Swells, gels and clots All Haemostatics Should be packed into the wound, ideal for cavitating wounds Require

17 Haemostatic Agents Kaolin Agents (e. g. QuikClot) Key ingredient kaolin clay Absorbs water from wound which increases concentration of clotting factors Chitosan Gauze (e. g. Celox) Key ingredient chitosan Swells, gels and clots All Haemostatics Should be packed into the wound, ideal for cavitating wounds Require 3-5 minutes of direct pressure Are generally 80% effective with a 30% rebleed rate 6 6 Littlejohn LF, et all, Comparison of Celox-A, ChitoFlex, WoundStat and combat gauze hemostatic agents versus standard gauze. Acad Emerg Med. 2011;18(4):340-50

Extremity Tourniquets Commercial Tourniquets Designed for significant extremity trauma Ineffective for junctional bleeds Provides circumferential pressure Application may cause significant pain

18 Extremity Tourniquets Commercial Tourniquets Designed for significant extremity trauma Ineffective for junctional bleeds Provides circumferential pressure Application may cause significant pain Despite proper training, approx. 80 % are not tightened adequately King, D., et al. Forward assessment of 79 prehospital battlefield tourniquets. J of Special Operations Medicine (4), Lee; Emerg Med J Tourniquet use in civilian prehospital setting, 2007;24:

Requires device specific training and assembly Junctional Emergency Treatment

19 Junctional Tourniquets Combat Ready Clamp (CRoC) Designed for inguinal and axillary bleeds Occludes distal circulation with built-in compression disk Requires device specific training and assembly Junctional Emergency Treatment Tool (JETT) Designed for massive inguinal groin injuries Only effective for lower extremity trauma

Anti-Fibrinolytics Tranexamic Acid (TXA) For use in suspected or confirmed internal bleeding Inhibits clot breakdown Must be administered within 3 hours of injury Not shown to increase risk of a

20 Anti-Fibrinolytics Tranexamic Acid (TXA) For use in suspected or confirmed internal bleeding Inhibits clot breakdown Must be administered within 3 hours of injury Not shown to increase risk of a clotting event (heart attack, stroke, or pulmonary embolism) Shakur, H., et al., Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2) Lancet (9734),

21 Challenges with Current Devices SLOW: 5 15 minutes LIMITED: No single device works for all injuries PAINFUL: Cause additional trauma EXPERTISE: Require medical knowledge and extensive training

Considerations in Haemorrhage Management (LOOK AT THE WOUND, NOT THE DEVICE) Mechanism of Injury Location of the bleeding: Scalp Extremities Junction

22 Considerations in Haemorrhage Management (LOOK AT THE WOUND, NOT THE DEVICE) Mechanism of Injury Location of the bleeding: Scalp Extremities Junction Abdomen Duration of bleeding Volume of blood loss Number of resources available to manage the patient Goal: Stop the bleeding! Transport time to definitive care

23 Use Case: Scalp laceration 36 yo man, hit by baseball bat Multiple large scalp wounds

24 Use Case: Scalp laceration itclamp was placed < 5 sec Bleeding stopped < 10 sec Comments of the treating physician: itclamp allowed continious visualization of the head and the possible swelling of the skull. Alternatively a bulky dressing would not have allowed for this assess-ment

25 Use Case: Palmar Artery Laceration Man walking with coffee cups falls while holding coffee cup long laceration to palm of hand Patient holds manual pressure per self all the way to hospital.

Clamp was placed, still with some bleeding, adrenaline soaked gauze added then able to stop

26 Use Case: Palmar Artery Laceration Staff relates that when patient removed pressure that blood pumped from wound shooting across the room. Patient has lacerated palmer artery. Clamp was placed, still with some bleeding, adrenaline soaked gauze added then able to stop bleeding Without clamp patient likely would have had temporary closure per ED and a revision per plastics at a later date

27 Use Case - Crushed Leg Prehospital 36 yo male, whose right leg was crushed in an industrial accident Two tourniquets on thigh due to massive bleeding on scene 2 units prbcs in helicopter BP 180/120, HR 130 on arrival

29 Use Case - Crushed Leg Arrival assessment Two open wounds Large medial wound with open, segmental tibial fracture Small 3 cm wound lateral to knee joint with open fibular head fracture and large degloving injury Tourniquet taken down revealing significant bleeding from smaller wound Degloved space packed with haemostatic gauze and the wound closed over packing with itclamp

31 ED / Trauma Room Course Controlled arterial haemorrhage with itclamp Conduct a complete patient assessement

34 Outcome Controlling haemorrhage allowed for: Complete ED assessment A single definitive operation with orthopedic and vascular repair Vascular intervention was done in a controlled situation nine (9) hours after arrival Bleeding injury was found to be a torn popliteal artery

35 Special Considerations Wounds: High velocity Entrance / Exit Patients: Pediatrics Geriatrics Anticoagulation Radiology: CT / Xray / Fluro No MRI Situation: Mass Casualty Natural Disaster Care Under Fire

36 itclamp Device application Tips and Tricks RULE OF THUMB: Longer wounds multiple device OBVIOUS FEEDBACK when devices not placed correctly CAN BE repositioned if needed CAN BE USED WITH other haemorrhage control techniques

37 Questions? M-115-CE Rev C

38 Summary Bleeding is a significant problem in trauma Rapid control of bleeding will affect patient outcomes Different strategies (wound closure, packing, pressure, pharmacological agents) alone or in combination will provide effective haemorrhage control itclamp is a rapid and easy yet safe and effective solution for hemostasis by wound closure

39 itclamp Application and Removal Procedures M-115-CE Rev C

40 itclamp Mechanism of Action The itclamp by Innovative Trauma Care instantly controls bleeding by sealing the skin closed to create a temporary pool of blood under pressure. This forms a stable clot until surgical repair.

41 CE Labeling INDICATIONS For Use: The itclamp TM 50 device is indicated for use as an acute skin closure device for short-term soft tissue approximation to inhibit severe bleeding in trauma wounds, lacerations, junctional bleeds, or surgical incisions. CONTRAINDICATIONS For Use: The itclamp50 is contraindicated where skin approximation cannot be obtained (for example, large skin defects under high tension). WARNINGS: This device is intended for temporary use only; use beyond three hours has not been studied. Patients must be seen promptly by medical personnel for device removal and surgical repair. Only use device as directed to avoid needle stick injury. Do not use where delicate structures are near the skin surface, within 10mm, such as the orbits of the eye. Will not control haemorrhage in non-compressible sites, such as the abdominal and chest cavities. Ensure personal protective equipment is utilized to protect against potential splashing of blood during application.

42 Device application Align needle tips along wound edges

43 itclamp Device application Insert needles alongside wound edges and close clamp Single gross motor skill Can be applied in adverse environments under stress and during transport Applied in seconds with minimal training 7,8 Can be applied over clothing (2 layers of denim) Applied with thick gloves Can be used on scalp, neck, extremities, axilla, neck and groin 8 7 Filips, D., et al. The itclamp controls junctional bleeding in a lethal swine exsanguination model. Prehospital Emergency Care; 2013; 17(4), Mottet, K. et al. Evaluation of the itclamp in a Human Cadaver Model. J of Trauma; March 2014; 76:3

44 Device application Close clamp Bleeding stops Hematoma forms

45 Additional Bleeding Control If bleeding continues: Close device more firmly Place additional devices for larger wounds (wounds longer than you thumb, require more than one device) Remove, reposition & reapply device

46 itclamp Removal / Repositioning Remove or reposition the itclamp if: The device was inadvertently closed prior to placement The device was positioned incorrectly Patient is ready for definitive surgical wound repair Release Buttons

47 itclamp Removal Squeeze the device Push in both release buttons Allow the pressure bars to open Rotate the needles out of the wound Remove device and dispose safely

48 Questions? For More Information: Clinical Support: US: North American Clinical Education Manager: Kim Marie C. Macygin, MSN RN Europe: International Clinical Education Manager: Thomas Semmel, EMT-P

: Your Haemorrhage Control Solution

: Your Haemorrhage Control Solution Shoulder Injury Leg Injury TM HAEMORRHAGE New solutions to control difficult bleeding are needed in emergent care, including pre-hospital, hospital and tactical environments.