1. Survey of Currently Available (FDA approved) and Future Hemostatic Dressings/Agents
Bijan S. Kheirabadi, PhD
IPR meeting
Chantilly , VA
Apr 25 , 2012
US Army Institute of Surgical Research

2. Are we there yet? - ++ / - Gauze QC .. ACS+ HemCon Combat Gauze Celox
Stop Arterial Bleeding
with 2-3 min compression -
++ / -
Side effect No ?
Ready and easy to use
Yes
Training requirement + ++
Lightweight and durable
+++
+ ++
2 yrs Shelf life
Stable in extreme condition
FDA approved
Biodegradable NO
Cost ($) 2
30
75
25
50 ? 2

3. Are we there yet? No Gauze QC .. ACS+ HemCon Combat Gauze Celox
Stop arterial/ venous bleeding w/o compression
(non-compressible site) No
Biodegradable/
Bioabsorbable
Stop coagulopathic bleeding
FDA approved for internal use 3

4. Evaluation of New Agents:
These new agents were screened in swine (n=3) standard arterial (femoral artery) or venous (liver) hemorrhage models:
ChitoGauze (arterial hem.)
Celox Gauze (arterial hem.)
Celox Rapid (arterial hem.)
Trauma (chitosan) Gauze (arterial hem.)
TraumaStat (arterial hem.)
SilverLeaf (arterial hem.)
Thrombin Patch (arterial hem.)
WetProtect (cyanoacrylate adhesive, venous hem)
ActCel (absorbable, venous hem)
ChitoGauze, Celox gauze and ActCel stopped bleeding in pigs with normal clotting function. 4

5. Evaluation of New Agents:
The successful agents were further tested in standard arterial (femoral artery) or venous (liver) hemorrhage model in pigs with coagulopathy.
ChitoGauze (arterial hem.)
Celox Gauze (arterial hem.)
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 ;15: 5

6. 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)

7. 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

8. 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.

9. 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.

10. 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.

11. 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.

12. 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

13. 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

14. Future Hemostat products
X-Stat-Dressing (pellets)
WRAPCLOT
TachoSil
Fibrin Patch

15. RevMedx XStat