The new standard in hemorrhage control Contents The need for - - PowerPoint PPT Presentation

The new standard in hemorrhage control

Contents

• The need for hemostats
• What is Celox Rapid?
• Benefits
• How it works
• Performance
• Independent trials of Celox Gauze

The need for hemostats in trauma

Combat lives can be saved

60 % of preventable battlefield deaths are from extremity hemorrhage.

Preventable Combat Death

Extremity Hemorrhage Tension pneumothorax Airway obstruction

Ref WDMET study

Civilians bleeding to death

Trauma: leading cause of death for persons under 401. Hemorrhage is the cause of death in around 40 % of civilian trauma.

Rapid action saves lives

What is Celox Rapid?

The fastest acting battlefield hemostat

The Rapid Treatment

• The fastest hemostatic agent.
• Works with just 60 second compression.
• Controls the most severe bleeding.
• Saves blood – saves lives.

Description

• Haemostatic agent for moderate

to severe bleeding.

• FDA cleared.
• Not a drug
• Z-folded high density gauze.
• 5 ft x 3”.
• Compact, rugged foil pouch with

4 quick-tear notches.

• Proprietary chitosan (Chito-RTM).
• Bonded to gauze.
• Contains 9 g of Chito-R.

Activated chitosan

Celox Rapid is the ONLY pre-hospital hemostatic dressing that meets each of the ideal criteria of the US Army Acquisition Support Center. “Able to stop actively bleeding arteries from hemorrhaging within 2 minutes”

Source: USAASC

Cut treatment time in half

Faster packing & 60 second compression

Combat Gauze* Celox Rapid

Rapid Packing

• Celox Rapid gauze is thicker than

typical gauze.

• Five foot of Celox Rapid fills the

same wound volume as 12 foot of Combat Gauze or Chitogauze.

• The time taken to pack in five foot of

gauze is significantly less than that taken to pack 12 foot.

Works on the most severe injuries

Haemostasis with 60 second compression.

0.0% 20.0% 40.0% 60.0% 80.0% 100.0%

Celox Rapid Gauze Combat Gauze

Study presented at ATACC 2011.

Independent testing at OHSU

• 60 % reduction in blood loss compared to Combat Gauze.

Schreiber M, at Combat Trauma Innovation, January 2012. Published in American Journal of Surgery 2013. Post-treatment blood loss (ml)

Gauze Combat Gauze Celox Rapid

No re-bleed during simulated evacuation test

Casualty driven over rough terrain course in vehicle.

No re-bleed: Hoggarth et al. poster at ATACCC 2011.

Field evacuation model

Works on traumatic bleeding.

In severe blood loss, blood becomes “coagulopathic” – does not clot normally, as shock and hypothermia set in.

Celox Rapid is effective on cooled, hypothermic blood. Celox Rapid is also effective on blood containing blood thinners.

Celox Rapid is safe

No heat produced. Chitosan : made up of sugars the body uses (glucosamine, N-acetyl glucosamine). Chitosan from Shellfish:

– tested on patients with known shellfish sensitivity. No allergies.

Does not activate clotting away from direct contact.

Celox Rapid is the only choice for fast, effective treatment of life- threatening bleeding. Rapid action saves lives.

How it works

1. Chito-R absorbs fluid and forms an adhesive gel. 2. Adhesive gel plug seals the wound, stops blood flow.

Simple mechanism

Adhesion is unique. Does not rely on the body’s intrinsic clotting capability.

How to use

1. Identify bleeding site. 2. Pack high density gauze direct to source

• f bleeding, maintain pressure on bleed

point. 3. Apply firm pressure for one minute or until bleeding stops. 4. Wrap and tie with a bandage to maintain pressure.

Direct contact + pressure = success!

Removal

1. Pull out the gauze.

Tip: the strong gauze comes out intact. Irrigate if needed if tightly adhered.

2. Remove any loose surface granules. 3. Irrigate liberally with saline.

Performance

Office of Naval Research Test Report

The key study for the CoTCCC

The test was done so that the CoTCCC could review the recommendation to use Combat Gauze Landmark study to change with support of CoTCCCC ONR did not have Celox Rapid at the time, so it was not in the test. Test included Celox Gauze. Celox Rapid is FDA approved and available.

The products

Celox Gauze 10 ft x 3 in Roll. Combat Gauze 12 ft x 3 in Z-fold. Combat Gauze XL 12 ft x 4in Double ply, Z fold. Celox Trauma Gauze 6 ft x 3 in roll. Chitogauze 12 ft x 3 in Z-fold.

Results: Haemostasis

• Celox Gauze 90 % hemostasis at end of study compared to

Combat Gauze 60 %.

Survival

90 % survival - matching the 90 % haemostasis.

CELOX Everyone else

Studies and references

Reduced blood loss – independent study from Oregon Health Science University -

– Kunio et al. poster at ATACCC 2011.

83 % hemostasis after one minute compression compared to 50 % for Combat Gauze . Packs in half the time of other hemostats. No re-bleeds in trial of casualty evacuation.

– All: Hoggarth et al. poster at ATACCC 2011.

100 % hemostasis compared to 83 % for Combat Gauze

– Schreiber M, presented at Combat Trauma Innovation, January 2012.

Published military and civilian use of Celox Gauze

– Tan, Bleeker, Field experience with a chitosan-based haemostatic dressing. MCI Forum, 3/4-2011.

Pdf copies available

Thank you