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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. US Army Institute of Surgical Research. Are we there yet?. Are we there yet?. Evaluation of New Agents:.

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US Army Institute of Surgical Research

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  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?

  3. Are we there yet?

  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.

  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, PrehospEmerg Care . 2011;15:477-82.

  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

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