US Army Institute of Surgical Research

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Survey of Currently Available (FDA approved) and Future Hemostatic Dressings/Agents

Bijan S. Kheirabadi, PhD

IPR meeting

Chantilly , VA Apr 25 , 2012

USAISR

Gauze QC .. ACS+

HemCon Combat Gauze

CeloxGauze

Stop Arterial Bleeding with 2-3 min compression

- - - ++ / - ++ / -

Side effect No ? No No ?

Ready and easy to use Yes Yes Yes Yes Yes

Training requirement + + ++ + +

Lightweight and durable +++ + + ++ + ++ + ++

2 yrs Shelf life Yes Yes Yes Yes Yes

Stable in extreme condition

Yes Yes Yes Yes Yes

FDA approved Yes Yes Yes Yes Yes

Biodegradable NO No No No No

Cost ($) 2 30 75 25 50 ?

Are we there yet?

USAISR

Gauze QC .. ACS+

HemCon Combat Gauze

CeloxGauze

Stop arterial/ venous bleeding w/o compression(non-compressible site)

No No No No No

Biodegradable/Bioabsorbable

No No No No No

Stop coagulopathic bleeding

No No No No No

FDA approved for internal use

No No No No No

Are we there yet?

USAISR

Evaluation of New Agents:

These new agents were screened in swine (n=3) standard arterial (femoral artery) or venous (liver) hemorrhage models:

1. ChitoGauze (arterial hem.)2. Celox Gauze (arterial hem.)3. Celox Rapid (arterial hem.)4. Trauma (chitosan) Gauze (arterial hem.)5. TraumaStat (arterial hem.)6. SilverLeaf (arterial hem.)7. Thrombin Patch (arterial hem.)8. WetProtect (cyanoacrylate adhesive, venous hem)9. ActCel (absorbable, venous hem)

ChitoGauze, Celox gauze and ActCel stopped bleeding in pigs with normal clotting function.

USAISR

Evaluation of New Agents:

The successful agents were further tested in standard arterial (femoral artery) or venous (liver) hemorrhage model in pigs with coagulopathy.

1. ChitoGauze (arterial hem.)2. Celox Gauze (arterial hem.)3. ActCel (absorbable, venous hem)

None were effective against coagulopathic hemorrhage.

Recent data showed no significant difference between Combat Gauze and chitosan-based dressings.

Schwartz et al, Prehosp Emerg Care . 2011;15:477-82.

USAISR

FDA approved Hemostatic Agents

• Cyanoacrylate ( 2 products)• Collagen & Thrombin ( FloSeal)• PEG Polymer (FocalSeal & CoSeal)• Albumin & Gluteraldehyde ( Bio Glue)• Fibrin Sealant ( Tisseel)• Collagen Enhanced FS (CoStasis)• TachoSil (fibrin sealant patch)• mRHD (modified Rapid Deployed Hemostat)

USAISR

Cyanoacrylate (Dermobond)

• Safety: Non-absorbable, External application only.

• Efficacy: Strong adhesive (Traumatic lacerations, skin closure)

• Ease to use: Room temperature storage, Single dose crushable ampule for linear application.

• Cost: $23/0.5 mL ampule

USAISR

FloSeal: Collagen & Thrombin

• Safety: Bovine collagen & thrombin,

Biodegradable, Antibody formation, thrombogenicity.

• Efficacy: Hemostasis in all surgical procedures except opthalmic & urologic surgery.

• Ease of use: Room temperature storage, 3 min prep time, single syringe applicator.

• Cost: $ 140 / 5ml kit.

USAISR

Focal Seal: Light activated PEG polymer

• Safety: Slowly biodegradable, low risk of infection

• Indication: Lung sealant, Pneumostatic device.

• Ease of use: (-20 – 4)o storage, three step process, light source, primer & sealant,

3-5 min application time.

• Cost: $425 / 8ml kit.

USAISR

CoSeal: Two component PEG polymer

• Safety: reabsorbed within 7 days

• Indication: Hemostasis, Vascular reconstruction procedures.

• Ease of use: Does not require light, (2-8)o

storage, 90% complete bond in 1 min.

• Cost: 250 / 2ml kit.

USAISR

Bio Glue: Cross-linked Albumin with Gluteraldehyde

• Safety: Slow Biodegradation, Precautions… nerves, microvascular anastomoses.

• Efficacy: Hemostasis in surgical repair of large vessels (aorta, femoral & carotid)

• Ease of use: room temperature, single use applicator (gun), full bonding in 2 minutes.

• Cost: $450 / 10 ml kit.

USAISR

Tisseel: Fibrin sealant• Safety: Human Fibrinogen and thrombin, Bovine

Aprotinin. Pathogen reduction (2 VI), Biodegradable.

• Indications: Cardiac surgery, Splenic trauma, Colonic anastomoses

• Ease to use: (2 – 6) º storage Multiple devices20 minute prep time

• Cost: $100/ml kit

USAISR

CoStasis: Collagen enhanced FS• Components: Bovine collagen (Type I, soluble), Bovine

thrombin (500U), and Autologous Plasma (PRP) • Safety Biodegradable, Antibody formation

• Indications: Hemostasis in all surgical procedures except neuro, ophthalmic & urologic.

• Ease to use: 2-6º storage, Sprayable manual applicator

• Cost: $200/2ml kit

USAISR

Future Hemostat products

• X-Stat-Dressing (pellets)• WRAPCLOT• TachoSil• Fibrin Patch

USAISR

RevMedx XStat