Survey of Currently Available FDA approved and Future Hemostatic DressingsAgents Bijan S Kheirabadi PhD IPR meeting Chantilly VA Apr 25 2012 Gauze QC ACS HemCon Combat Gauze ID: 778669
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Slide1
US Army Institute of Surgical Research
Survey of Currently Available (FDA approved) and Future Hemostatic Dressings/Agents
Bijan S. Kheirabadi, PhD
IPR meeting
Chantilly , VA
Apr 25 , 2012
Slide2Gauze
QC .. ACS+
HemCon
Combat Gauze
Celox
GauzeStop Arterial Bleeding with 2-3 min compression---++ / - ++ / - Side effectNo?NoNo?Ready and easy to useYesYesYesYes Yes Training requirement++++++Lightweight and durable+++++ +++ +++ ++2 yrs Shelf lifeYesYes Yes Yes Yes Stable in extreme conditionYesYes Yes Yes Yes FDA approvedYesYes Yes Yes Yes BiodegradableNONoNoNoNoCost ($)23075 2550 ?
Are we there yet?
Slide3Gauze
QC .. ACS+
HemCon
Combat Gauze
Celox
GauzeStop arterial/ venous bleeding w/o compression(non-compressible site)NoNoNoNo No Biodegradable/BioabsorbableNoNoNoNoNoStop coagulopathic bleedingNoNoNoNo No FDA approved for internal useNoNo No No No Are we there yet?
Slide4Evaluation 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.
Slide5Evaluation 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 . 2011;15:477-82.
Slide6FDA 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)
Slide7Cyanoacrylate (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
Slide8FloSeal: 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.
Slide9Focal Seal: Light activated PEG polymer
Safety: Slowly biodegradable, low risk of infectionIndication:
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.
Slide10CoSeal: Two component PEG polymerSafety: 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.
Slide11Bio Glue: Cross-linked Albumin with GluteraldehydeSafety:
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.
Slide12Tisseel: 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 timeCost: $100/ml kit
Slide13CoStasis: Collagen enhanced FS
Components: Bovine collagen (Type I, soluble), Bovine thrombin (500U), and Autologous Plasma (PRP)
Safety Biodegradable, Antibody formationIndications: Hemostasis in all surgical procedures except neuro, ophthalmic & urologic.Ease to use:
2-6º storage, Sprayable manual applicatorCost: $200/2ml kit
Slide14Future Hemostat products
X-Stat-Dressing (pellets)WRAPCLOTTachoSilFi
brin Patch
Slide15RevMedx
XStat