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US Army Institute of Surgical Research
C om b a t C a s u a lty C a re
P R O T E C T
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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