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John Puetz M.D.

The Most Commonly Administered Hemostatic Agent in the U.S. John Puetz M.D. What is the most commonly administered Hemostatic agent in the U.S. ? Advate Kogenate Xyntha Other. Are the indications for rFVIII known ? Has rFVIII been shown to be effective for these indications ?

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John Puetz M.D.

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  1. The Most Commonly Administered Hemostatic Agent in the U.S. John Puetz M.D.

  2. What is the most commonly administered Hemostatic agent in the U.S. ? Advate Kogenate Xyntha Other Are the indications for rFVIII known ? Has rFVIII been shown to be effective for these indications ? Has the dose of rFVIII been determined for its indications? Have the toxicities of rFVIII been studied/known ? How many people in the U.S. have Hemophilia ? 20,000 200,000 2,000,000

  3. Plasma Plasma: Liquid Component of Blood. What’s Left After Cellular Elements Removed Transfused: Fresh Frozen FP24 SD FFP Cryopoor Plasma Fresh Source: Plasmapheresis Recovered – Whole Blood or FFP

  4. Fresh Frozen Plasma A History Lesson 1818 First described Human to Human Blood Transfusion (Blundell)

  5. Fresh Frozen Plasma A History Lesson Plasma Transfusion History Blood Substitutes: Salt Solutions/Ringers 1859 1870s Bowditch and Luciani infused Sheep Serum into Frog Heart By 1884 Pre-Clinical Studies established the presence of vaso-active substances released by blood clotting 1917-19 Replace 96% of dog blood with horse plasma WWI Advantage of citrated plasma over whole blood recognized 1918 First use of human plasma (fresh) transfusion – Influenza Antitoxin 1930’s citrated plasma (fresh) routinely used for transfusion 1935 plasma used as a hemostatic agent for the first time WWII Frozen and Dried Plasma developed 1932-41 Cryoprecipitate/Labile Factors Present in Plasma

  6. FFP Use in Children • 1934 First Description FFP use in Child (sepsis) • 1936-1963 Case Reports and Small Series • 1964 First Randomized Controlled Trial Sepsis Nutritional Protein Deficiencies Burns Nephrotic Syndrome Hemophilia Sickle Cell Anemia Acute Lymphoblastic Leukemia Immune Thrombocytopenia Purpura

  7. FFP Use in Children 1934 First Description FFP use in Child (sepsis) 1936-1963 Case Reports and Small Series 1964 First Randomized Controlled Trial 1968 First Large Neonatal Series Thrombotest: Designed to Monitor Coumadin Developed in late 1950s by Owren Bovine Plasma Deficient to II,VII,IX and X Can Use Capillary Specimen • 286 Consecutive Low Birth Weight Neonates • Coagulation Status Assessed By The Thrombotest • 59 Died; 21 Had ICH • Thrombotest < 10% increased risk for Death/ICH • Plasma 10 ml/kg lower risk of death p=0.07 • 10 ml/kg plasma “usually raises the thrombotest • level to about 30%.” • 53 Subjects (13/40)with Heart Disease • Surgery with Extracorporeal Circulation • Randomized FFP or Standard Care • 250/500 mls FFP • No reduction in bleeding

  8. Proposed Indications For FFP

  9. Coagulation Factors Normal Range 50-150 % or 50-150 u/dl (units per deciliter) What is a unit ? The amount of coagulation factor activity present in 1 ml of normal plasma Normal factor IX activity = 1 u/ml X 100 ml/dl = 100 u/dl = 100% Target factor activity for bleeding hemophilia patient is 40-50% 10 ml/kg FFP increase factor IX level by 10% - inadequate for hemostasis (need 40 ml/kg)

  10. Proposed Indications For FFP

  11. FFP used to Correct Abnormal Clotting Tests PT/aPTT Johnson et al Arch Dis Child 1982; 57: 950-52 Puetz et al J Pediatr HematolOncol 2009; 31: 901-906. Holland et al Am J ClinPathol 2006; 126: 133-139

  12. Proposed Indications for FFP Number of Pediatric Randomized Trials: 22 Number of Adult Randomized Trials: 43 Number of Adult Randomized Trials Showing Benefit: 3 Stanworth et al British Journal of Haematol2004; 126: 139-152 Yang L. Transfusion 2012 epub Jan 18

  13. FFP Use in Children Describe FFP Use in Children in the U.S. Who, What, Where, When, Why Retrospective, Cohort Study Preexisting De-Identified Data Pediatric Health Information System (PHIS) Administrative Database 43 Tertiary Pediatric U.S. Children’s Hospitals Affiliated with Child Health Corporation of America (CHCA) Puetz et al. J Pediatrics 2012 Feb;160(2):210-215

  14. CHCA Participating Children’s Hospitals

  15. PHIS FFP Admissions 2002-2009 3,252,149 Admissions Overall 92,731 FFP Admissions The Percent of FFP Admissions (2.85) Did Not Change Between 2002-2009 (p = 0.10) 54% Infants 34% CPB Code

  16. PHIS FFP Admissions Complications Overall: Venous Thrombosis 10% Arterial Thrombosis 5% Rate of Venous Thrombosis With FFP Admissions Increased Tenfold Association not Causation

  17. PHIS FFP Admissions Complications • 12 y.o. male with O.M. • Developed Mastoiditis and Septicemia • Treated with Antimicrobials and Surgery • Supported with FFP • Developed Venous Sinus Thrombosis • Completely Recovered First English Language Case Report - 1934 Hemolytic Streptococci Antimicrobial – IM Injections of AutogenousLysate (bacteriophage) FFP Neutralized the “toxin of the disease” Did FFP contribute to the sinus thrombosis?

  18. The Most Commonly Administered Hemostatic Agent in the U.S. Are the indications for known ? Has been shown to be effective for these indications ? Has the dose of been determined for its indications? Have the toxicities of been studied/known ? rFVIII FFP rFVIII FFP rFVIII FFP rFVIII FFP 2,000,000 vs 20,000

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