DOCSLIB.ORG

December 4 Saturday

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
December 4 Saturday ASH Meeting – Dec 5-8, 2020 CanVECTOR Oral & Poster Presentations Day / Time / Session Title Presenter Wednesday – December 2 December 2- 7:05 AM-8:30 AM The Immunohemostatic Response to Ed Pryzdial, PhD Infection Overview Program: Scientific Workshops @ ASH Session: The Immunohemostatic Response to Infection Friday – December 4 December 4 - 7:05 AM-8:05 AM Approach to Pregnancy and Delivery in Michelle Sholzberg, MDCM, FRCPC, MSc Women with Bleeding Disorders Program: Scientific Workshops @ ASH Session: Thrombosis and Bleeding in Pregnancy Prevention and Treatment of Venous Leslie Skeith, MD Thromboembolism in Pregnancy Saturday – December 5 December 5 - 7:00 AM-3:30 PM A Retrospective Cohort Study Evaluating the Kanza Naveed, Grace H Tang, MSc, McKenzie Safety and Efficacy of Peri-Partum Quevillon, RN, BScN, MN, Filomena Meffe, MD, MSc, Program: Oral and Poster Abstracts Tranexamic Acid for Women with Inherited Rachel Martin, MD, Jillian M Baker, MD, MSc, and Bleeding Disorders Michelle Sholzberg, MDCM, FRCPC, MSc Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I Number: 863 Page 1 of 7 Day / Time / Session Title Presenter December 5 - 7:00 AM-3:30 PM A Retrospective Cohort Study Evaluating the Kanza Naveed, Grace H Tang, MSc, McKenzie Safety and Efficacy of Peri-Partum Quevillon, RN, BScN, MN, Filomena Meffe, MD, MSc, Program: Oral and Poster Abstracts Tranexamic Acid for Women with Inherited Rachel Martin, MD, Jillian M Baker, MD, MSc, and Bleeding Disorders Michelle Sholzberg, MDCM, FRCPC, MSc Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I Number: 863 Frequency of Venous Thromboembolism in Mark Crowther, MD, David A. Garcia, MD, Jason 6513 Patients with COVID-19: A Hill, MD, MSc, Bryan Savage, Shira Peress, Kevin Retrospective Study Chang and Steven Deitelzweig, MD Number: 875 Potency-Adjusted Analyses of a Head-to- Alexander Solms, Anita Shah, Sara Wiegmann, Head Pharmacokinetic Study of Damoctocog Maurice Ahsman, Erik Berntorp, Andreas Tiede, MD, Alfa Pegol (BAY 94-9027) and Efmoroctocog Alfonso Iorio, MD, PhD, Maria Elisa Mancuso, Alfa (rFVIIIFc) in Patients with Severe Tihomir Zhivkov and Toshko Lissitchkov Hemophilia A Number: 878 December 5 - 7:00 AM-3:30 PM Efficacy and Safety of Tinzaparin in CAT Agnes Y. Lee, MD, MSc, Pieter W. Kamphuisen, MD, Patients with Metastatic Disease PhD, Rupert Bauersachs, MD, PhD, Karen Turpin, Program: Oral and Poster Abstracts BScN, MSc, Jes Birger Hansen and Alok A Khorana, MD Session: 332. Anticoagulation and Antithrombotic Therapy: Poster I Number: 887 December 5 - 7:00 AM-3:30 PM Thrombotic Complications in a Canadian Camille Simard, MD, Maral Koolian, MD, MSc, Population of Critically Ill Patients with FRCPC, Diana Escobar, MD, Mark Blostein, MD Program: Oral and Poster Abstracts COVID-19 FRCPC, Jed Lipes, MD, FRCPC, Adelina Teona Avram, MD, Ryan Kerzner, B Pharm, MSc, Helen Session: 332. Anticoagulation and Antithrombotic Mantzanis, B Pharm, MSc, Mateo Porres Aguilar, Therapy: Poster I MD and Vicky Tagalakis, MD, FRCPC Number: 896 Page 2 of 7 Day / Time / Session Title Presenter December 5 - 7:00 AM-3:30 PM The Prognostic Validity of the Acute Myeloid Shannon Murphy, MD, MBA, Brian Harnett, MD, Kara Leukemia Composite Model in Predicting Matheson, David M. Jones, MD, Abdulrahim Program: Oral and Poster Abstracts Risks of One-Year Mortality Among Patients Basendwah, MD, Sudeep P Shivakumar, MD, BSc in Atlantic Canada: A Multi-Centre and Mahmoud Elsawy, MB Session: 613. Acute Myeloid Leukemia: Clinical Experience Studies: Poster I Number: 999 December 5 - 7:00 AM-3:30 PM Detection of Right Ventricular Dysfunction in Nicholas L Jackson Chornenki, MD, Khashayar Acute Pulmonary Embolism By CT Scan: A Poorzargar, Maaz Shanjer, Lawrence Mbuagbaw, Program: Oral and Poster Abstracts Systematic Review and Meta-Analysis Mark Crowther, MD and Deborah M Siegal, MD Session: 901. Health Services Research—Non- Number: 1573 Malignant Conditions: Poster I December 5 - 7:00 AM-3:30 PM Reducing Cytogenetic Testing in the Era of Eri Kawata, MD, PhD, Benjamin Hedley, PhD, Next Generation Sequencing (NGS); Are We Benjamin Chin-Yee, MD, Anargyros Xenocostas, MD, Program: Oral and Poster Abstracts Choosing Wisely? FRCPC, Alejandro Lazo-Langner, MD, MSc, Cyrus C. Hsia, MD, BSc, FRCPC, Kang Howson-Jan, MD, Session: 903. Health Services Research— FRCPC, Ping Yang, PhD, DABMGG, Michael Levy, Malignant Conditions (Myeloid Disease): Poster I PhD, Stephanie Santos, Chris Howlett, Hanxin Lin, PhD, Bekim Sadikovic, PhD, DABMGG, FACMG and Ian Chin-Yee, MD, FRCPC Number: 1612 December 5 - 12:00 PM Impact of Thromboembolism on Overall and Marie-Claude Pelland-Marcotte, MD, PhD, Ketan Event-Free Survival in Children with Acute Kulkarni, MD, Uma Athale, MD, MBBS, MSc, Jason Program: Oral and Poster Abstracts Lymphoblastic Pole, PhD, Leonardo R. Brandao, MD and Lillian Sung, MD, PhD Type: Oral Number: 201 Session: 904. Outcomes Research - Non-Malignant Conditions: Venous Thromboembolism Associated with Cancer and/or COVID-19 Page 3 of 7 Day / Time / Session Title Presenter December 5 - 2:15 PM Safety and Efficacy of the Contact Activation Christina U Lorentz, PhD1, Norah G Verbout, PhD1, Inhibitor AB023 in Patients with End-Stage Joseph J Shatzel, MD, Michael Wallisch, PhD1, Program: Oral and Poster Abstracts Renal Disease on Chronic Hemodialysis: A Brandon D Markway, PhD, Monica T Hinds, PhD, Type: Oral Phase 2, Double-Blind, Randomized, Placebo- Owen J T McCarty, PhD, David Gailani, MD, Jeffrey I. Controlled Trial Weitz, MD, FRCPC, Erik I Tucker, PhD and András Session: 332. Anticoagulation and Antithrombotic Gruber, MD Therapy: Novel Agents, Reversal Drugs and Indications Number 237 December 5 - 3:00 PM Not All Patients Benefit from Switching to Olav Versloot, MSc., Emma Iserman, Pierre Chelle, Ehl: Results from the Wapps Database PhD, Federico Germini, MD, MSc, Tushara Mathew, Program: Oral and Poster Abstracts Alfonso Iorio, MD, PhD, and Kathelijn Fischer Type: Oral Number 234 Session: 332. Anticoagulation and Antithrombotic Therapy: Novel Agents, Reversal Drugs and Indications December 5 - 3:15 PM Terminal Half-Life of Factor VIII/IX Olav Versloot, MSc., Emma Iserman, Pierre Chelle, According to Age and Blood Group Based on PhD, Federico Germini, MD, MSc Tushara Mathew, Program: Oral and Poster Abstracts 8550 Assessments Alfonso Iorio, MD, PhD and Kathelijn Fischer Type: Oral Number 235 Session: 322. Disorders of Coagulation or Fibrinolysis: Hemophilia: Genes, Joints, and PK Sunday – December 6 December 6 - 7:00 AM-3:30 PM Analysis of Hemophilia a Outcomes and Adrienne Lee, MD, Federico Germini, MD, MSc, Treatment Patterns Using Real-World Data Man-Chiu Poon, MD, Arun Keepanasseril, Quazi Program: Oral and Poster Abstracts from the Canadian Hemophilia Bleeding Ibrahim, MSc, Aijing Shang, MD, PhD, Francis Nissen, Disorder Registry Oliver Meier, Cami S. Sima, MD, Davide Matino and Session: 322. Disorders of Coagulation or Alfonso Iorio, MD, PhD Fibrinolysis: Poster II Number: 1793 Page 4 of 7 Day / Time / Session Title Presenter December 6 - 7:00 AM-3:30 PM A Retrospective Review of the Monika Oliver, MD, BSc, Mariam Goubran, BSc, Appropriateness of D-Dimer Ordering and Jacqueline Karathra, BMSc, Mohammad Karkhaneh, Program: Oral and Poster Abstracts Interpretation Using Wells' Clinical PhD and Cynthia M. Wu, MD, FRCPC Probability Criteria Session: 901. Health Services Research—Non- Number: 2483 Malignant Conditions: Poster II Patient Adherence to Medication within a Kwadwo Osei Bonsu, BPharm(Hons), PhD, New Multidisciplinary Thrombosis Service Stephanie W Young, PharmD, Tiffany Lee, BSc(Pharm), Pharm.D, Hai V Nguyen, PhD and Rufaro S Chitsike, MBChB, MMed(Haem), FCPath(Haem), Cert Clin(Haem) Number: 2493 December 6 - 7:00 AM-3:30 PM Association between Aging and Health Status Federico Germini, MD, MSc, Suzanne O'Callaghan, in Persons Living with Hemophilia and BA, Chatree Chai-Adisaksopha, MD, PhD, Randall Program: Oral and Poster Abstracts Controls without a Bleeding Disorder – Curtis, MB, Neil Frick, Michael B. Nichol, PhD, Declan Insights from the Probe Study Noone, MSc, Brian O'Mahony, David Page, Jeffrey Session: 904. Outcomes Research—Non- Stonebraker, Mark W Skinner, JD, and Alfonso Malignant Conditions: Poster II Iorio, MD, PhD Number: 2529 December 6 - 12:00 PM Suboptimal Screening for Iron Deficiency in Jennifer Teichman, MD, Michelle Sholzberg, Pregnancy in a High Resource Setting MDCM, FRCPC, MSc, Rosane Nisenbaum, PhD and Program: Oral and Poster Abstracts Andrea Lausman, MD, FRCSC Type: Oral Number 424 Session: 901. Health Services Research—Non- Malignant Conditions II Page 5 of 7 Day / Time / Session Title Presenter December 6 - 1:15 PM Deep Vein Thrombosis Diagnosis with D- Kerstin de Wit, MBChB, MDm MSc, Sameer Dimer Adjusted to Clinical Probability Parpia, Sam Schulman, MD, PhD, FRCPC, Fred Program: Oral and Poster Abstracts Spencer, MD, FRCP, Sangita Sharma, Marc Afilalo, Susan Kahn, MD, Gregoire Le Gal, MD, PhD, Type: Oral Sudeep P Shivakumar, MD, BSc, Shannon M. Bates, MD, FRCPC, MSc, Cynthia M. Wu, MD, Session: 901. Health Services Research—Non- FRCPC, Alejandro Lazo-Langner, MD, MSc, Malignant Conditions II Frederick D’Aragon, MD, Jean-Francois Deshaies, Luciana Spadafora, Jim Julian and Clive Kearon, MB, PhD Number 429 Monday – December 7 December 7 - 7:00 AM-3:30 PM Platelet Membrane Procoagulation in Adrienne Lee, MD, Lorriane Chow, BSc, MD, FRCPC, Preeclampsia Leslie Skeith, MD, Joshua A Nicholas, BHSc, MD, Program: Oral and Poster Abstracts Man-Chiu
Load more

Recommended publications
  • Thrombocytopenia
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Review: Thrombocytopenia Date of Review: January 2019 End Date of Literature Search: 11/05/2018 Purpose for Class Review: Treatments for thrombocytopenia are being reviewed for the first time, prompted by the recent approval of three new drugs; avatrombopag (Doptelet®), fostamatinib (Tavalisse™) and lusutrombopag (Mulpleta®). Research Questions: 1. What is the evidence for efficacy and harms of thrombocytopenia treatments (avatrombopag, eltrombopag, lusutrombopag, fostamatinib, and romiplostim)? 2. Is there any comparative evidence for therapies for thrombocytopenia pertaining to important outcomes such as mortality, bleeding rates, and platelet transfusions? 3. Is there any comparative evidence based on the harms outcomes of thrombocytopenia treatments? 4. Are there subpopulations of patients for which specific thrombocytopenia therapies may be more effective or associated with less harm? Conclusions: Three guidelines, six randomized clinical trials and five high-quality systematic reviews and meta-analyses met inclusion criteria for this review. There was insufficient direct comparative evidence between different therapies to treat thrombocytopenia. A majority of trials were small and of short duration. Guidelines recommend corticosteroids and intravenous immunoglobulin (IVIg) as first-line therapy for most adults with idiopathic thrombocytopenia (ITP). Thrombopoietin receptor agonists (TPOs) and the tyrosine kinase inhibitor, fostamatinib, are recommended as second-line treatments after failure of at least one other treatment.1–3 Avatrombopag and lusutrombopag are only approved for short-term use before procedures in patients with chronic liver failure.
    [Show full text]
  • Review Article
    SHOCK, Vol. 41, Supplement 1, pp. 44Y46, 2014 Review Article TRANEXAMIC ACID, FIBRINOGEN CONCENTRATE, AND PROTHROMBIN COMPLEX CONCENTRATE: DATA TO SUPPORT PREHOSPITAL USE? Herbert Scho¨chl,*† Christoph J. Schlimp,† and Marc Maegele‡ *AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University Salzburg, Salzburg; and †Ludwig Boltzmann Institute for Experimental and Clinical and Traumatology, AUVA Research Centre, Vienna, Austria; and ‡Department of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne-Merheim Medical Center, Cologne, Germany Received 15 Sep 2013; first review completed 1 Oct 2013; accepted in final form 8 Nov 2013 ABSTRACT—Trauma-induced coagulopathy (TIC) occurs early after severe injury. TIC is associated with a substantial increase in bleeding rate, transfusion requirements, and a 4-fold higher mortality. Rapid surgical control of blood loss and early aggressive hemostatic therapy are essential steps in improving survival. Since the publication of the CRASH-2 study, early administration of tranexamic acid is considered as an integral step in trauma resuscitation protocols of severely injured patients in many trauma centers. However, the advantage of en route administration of tranexamic acid is not proven in prospective studies. Fibrinogen depletes early after severe trauma; therefore, it seems to be reasonable to maintain plasma fibrinogen as early as possible. The effect of prehospital fibrinogen concentrate administration on outcome in major trauma patients is the subject of an ongoing prospective investigation. The use of prothrombin complex concentrate is potentially helpful in patients anticoagulated with vitamin K antagonists who experience substantial trauma or traumatic brain injury. Beyond emergency reversal of vitamin K antagonists, safety data on prothrombin complex concentrate use in trauma are lacking.
    [Show full text]
  • Reversal of Anticoagulation in GI Bleeding
    Blood and Guts Reversal of anticoagulation in GI Bleeding John Hanley Consultant Haematologist Newcastle Hospitals NHS Trust [email protected] Healthy situation Haemostatic seesaw in a happy balance Clinical Thrombosis Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome Anticoagulation Therapy Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus ANTICOAGULANT Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis DRUG Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome Successful Anticoagulation Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis ANTICOAGULANT Metallic Heart Valves DRUG Ventricular Assist Devices Antiphospholipid syndrome Unsuccessful Anticoagulation Atrial Fibrillation Deep Vein Thrombosis Pulmonary Embolus Cerebral Sinus Thrombosis Mesenteric Vein Thrombosis Arterial Embolus or Thrombosis Metallic Heart Valves Ventricular Assist Devices Antiphospholipid syndrome ANTICOAGULANT DRUG Steady increase in numbers of patients receiving anticoagulation ≈1-2% of the UK population anti-coagulated AF 70% VTE 25% Other 5% 70000 60000 50000 40000 30000 20000 10000 0 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 Anticoagulants / Anti-platelets Unfractionated Heparin Low Molecular Weight Heparin Warfarin Other Vit
    [Show full text]
  • Reversal of Anticoagulation 14
    Table 6. Continued from page 4. References Continued from page 5. Primary 7. Kearon C. Hirsh J. Management of anticoagulation before and after elective surgery. New England Journal of Medicine. 336(21):1506-11, 1997. Anticoagulant Anticoagulation Reversal Anticoagulant Half-Life Excretion Therapeutic Anticoagulation Dose 8. Hanley JP. Warfarin reversal. Journal of Clinical Pathology. 57(11):1132-9, 2004 Nov. Action Monitoring Agents Mode 9. Holland L. Warkentin TE. Refaai M. Crowther MA. Johnston MA. Sarode R. Suboptimal effect of a three-factor prothrombin complex concen- trate (Profilnine-SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion. 49(6):1171-7, 2009 Pediatrics Adults 10. Bauer KA. New anticoagulants. Hematology Am Soc Hematol Educ Program. 2006:450-6. Xa-Inhibitors 11. O'Connell NM. Perry DJ. Hodgson AJ. O'Shaughnessy DF. Laffan MA. Smith OP. Recombinant FVIIa in the management of uncontrolled hemorrhage. Transfusion. 43(12):1711-6,2003. Winter 2011 Fondaparinux: 17-21 Renal Anti-thrombin 0.15 mg/kg, daily, SC <50 kg: 5 mg, SC, Typically no rFVIIa 12. O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM. Thromboembolic adverse events after use of recombinant human coagulation factor (Arixtra) hours mediated inhibi- daily monitoring (NovoSeven) VIIa. JAMA. 2006 Jan 18;295(3):293-8. tion of factor Xa 50-100 kg: 7.5 mg, required SC, daily Anti-factor Xa 13. Riess HB. Meier-Hellmann A. Motsch J. Elias M. Kursten FW. Dempfle CE. Prothrombin complex concentrate (Octaplex) in patients requiring >100 kg: 10 mg daily (Calibrated with immediate reversal of oral anticoagulation.
    [Show full text]
  • A Randomized Study of 4-Factor Prothrombin Complex Concentrate and Authors: Jerrold H
    A Randomized Study of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding, Thrombin Generation, and Pharmacodynamics After Punch Biopsies in Rivaroxaban Treated Subjects With Supratherapeutic Drug Levels Authors: Jerrold H. Levy, MD1; Kenneth T. Moore, MS2; Matthew D. Neal, MD3; David Schneider, MD4; Victoria S. Marcsisin, MS2; Jay Ariyawansa, MS2; Jeffrey I. Weitz, MD5 1Duke University School of Medicine, Durham, North Carolina, United States; 2Janssen Pharmaceuticals, Janssen Scientific Affairs, Titusville, New Jersey, United States; 3University of Pittsburgh, Pittsburgh, Pennsylvania, United States; 4University of Vermont, Burlington, Vermont, United States; 7057 Figure 3 dra 1.4 5 This tagline is for informaon only; McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada DO NOT PRINT Figure 3. Time course of (A) prothrombin time (PT) and (B) endogenous thrombin Introduction Results potential (ETP) on mean absolute values change from baseline for treatment with 4F-PCC (Group A), TXA (Group B), and placebo (saline control) (Group C). • Oral factor Xa (FXa) inhibitors, including rivaroxaban, are replacing vitamin K • Of the 147 subjects enrolled (49 in each of the 3 cohorts), 145 (98.6%) completed A End of 4F-PCC/Placebo Infusion antagonists such as warfarin for many thromboembolic indications the study End of TXA/Placebo Infusion • Reversal of the anticoagulant effects of FXa inhibitors is important in the event of • Subject characteristics were comparable between the 3 cohorts (Table 1) clinically relevant bleeding 4F-PCC – The majority of subjects enrolled were male (70.1%) and white (66.0%), with a 25 2 TXA • Currently, there are no therapies approved for reversing oral FXa inhibitors, but median age of 28.0 years and a mean BMI of 25.0 kg/m Saline 4-factor prothrombin concentrate (4F-PCC) and tranexamic acid (TXA) have been suggested for this purpose lues, seconds Table 1.
    [Show full text]
  • Avatrombopag and Lusutrombopag For
    Journals Library Health Technology Assessment Volume 24 • Issue 51 • October 2020 ISSN 1366-5278 Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis Nigel Armstrong, Nasuh Büyükkaramikli, Hannah Penton, Rob Riemsma, Pim Wetzelaer, Vanesa Huertas Carrera, Stephanie Swift, Thea Drachen, Heike Raatz, Steve Ryder, Dhwani Shah, Titas Buksnys, Gill Worthy, Steven Duffy, Maiwenn Al and Jos Kleijnen DOI 10.3310/hta24510 Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis Nigel Armstrong ,1* Nasuh Büyükkaramikli ,2 Hannah Penton ,2 Rob Riemsma ,1 Pim Wetzelaer ,2 Vanesa Huertas Carrera ,1 Stephanie Swift ,1 Thea Drachen ,1 Heike Raatz ,1 Steve Ryder ,1 Dhwani Shah ,1 Titas Buksnys ,1 Gill Worthy ,1 Steven Duffy ,1 Maiwenn Al 2 and Jos Kleijnen 1 1Kleijnen Systematic Reviews, York, UK 2Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, the Netherlands *Corresponding author Declared competing interests of authors: Rob Riemsma is a member of the National Institute for Health Research Health Technology Assessment and Efficacy and Mechanism Evaluation Editorial Board. Published October 2020 DOI: 10.3310/hta24510 This report should be referenced as follows: Armstrong N, Büyükkaramikli N, Penton H, Riemsma R, Wetzelaer P, Huertas Carrera V, et al. Avatrombopag and lusutrombopag for thrombocytopenia in people with chronic liver disease needing an elective procedure: a systematic review and cost-effectiveness analysis. Health Technol Assess 2020;24(51). Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/ Clinical Medicine.
    [Show full text]
  • New Drug Evaluation Monograph Template
    © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-2596 Drug Class Review: Thrombocytopenia Date of Review: January 2019 End Date of Literature Search: 11/05/2018 Purpose for Class Review: Treatments for thrombocytopenia are being reviewed for the first time, prompted by the recent approval of three new drugs; avatrombopag (Doptelet®), fostamatinib (Tavalisse™) and lusutrombopag (Mulpleta®). Research Questions: 1. What is the evidence for efficacy and harms of thrombocytopenia treatments (avatrombopag, eltrombopag, lusutrombopag, fostamatinib, and romiplostim)? 2. Is there any comparative evidence for therapies for thrombocytopenia pertaining to important outcomes such as mortality, bleeding rates, and platelet transfusions? 3. Is there any comparative evidence based on the harms outcomes of thrombocytopenia treatments? 4. Are there subpopulations of patients for which specific thrombocytopenia therapies may be more effective or associated with less harm? Conclusions: Three guidelines, six randomized clinical trials and five high-quality systematic reviews and meta-analyses met inclusion criteria for this review. There was insufficient direct comparative evidence between different therapies to treat thrombocytopenia. A majority of trials were small and of short duration. Guidelines recommend corticosteroids and intravenous immunoglobulin (IVIg) as first-line therapy for most adults with idiopathic thrombocytopenia (ITP). Thrombopoietin receptor agonists (TPOs) and the tyrosine kinase inhibitor, fostamatinib, are recommended as second-line treatments after failure of at least one other treatment.1–3 Avatrombopag and lusutrombopag are only approved for short-term use before procedures in patients with chronic liver failure.
    [Show full text]
  • Informationen Zur
    Kriterien zur Bestimmung der zweckmäßigen Vergleichstherapie und Recherche und Synopse der Evidenz zur Bestimmung der zweckmäßigen Vergleichstherapie nach § 35a SGB V Vorgang: 2017-B-074 Damoctocog alfa pegol Stand: Juni 2017 I. Zweckmäßige Vergleichstherapie: Kriterien gemäß 5. Kapitel § 6 VerfO G-BA Damoctocog alfa pegol_2017-B-074 [Behandlung und Prophylaxe der Hämophilie A] Kriterien gemäß 5. Kapitel § 6 VerfO Sofern als Vergleichstherapie eine Arzneimittelanwendung in Betracht kommt, muss das Siehe Tabelle „II. Zugelassene Arzneimittel im Anwendungsgebiet“ Arzneimittel grundsätzlich eine Zulassung für das Anwendungsgebiet haben. Sofern als Vergleichstherapie eine nicht- medikamentöse Behandlung in Betracht kommt, muss nicht angezeigt diese im Rahmen der GKV erbringbar sein. Beschlüsse/Bewertungen/Empfehlungen des - Richtlinie Ambulante Behandlung im Krankenhaus nach § 116b des Fünften Gemeinsamen Bundesausschusses zu im Buches Sozialgesetzbuch (SGB V) (Anlage 2, Nr. 2: Diagnostik und Versorgung Anwendungsgebiet zugelassenen Arzneimitteln/nicht- von Patienten mit Gerinnungsstörungen (Hämophilie)) medikamentösen Behandlungen - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Turoctocog alfa vom 3. Juli 2014 - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Simoctocog alfa vom 7. Mai 2015 - Beschluss zur Nutzenbewertung nach § 35a SGB V zum Wirkstoff Efmoroctocog alfa vom 16. Juni 2016 Die Vergleichstherapie soll nach dem allgemein anerkannten Stand der medizinischen Erkenntnisse zur Siehe systematische Literaturrecherche
    [Show full text]
  • Clinical Pharmacology of Aminocaproic and Tranexamic Acids
    J Clin Pathol: first published as 10.1136/jcp.s3-14.1.41 on 1 January 1980. Downloaded from J Clin Pathol, 33, Suppl (Roy Coll Path), 14, 41-47 Clinical pharmacology of aminocaproic and tranexamic acids INGA MARIE NILSSON From the Coagulation Laboratory, University ofLund, Allmdnna Sjukhuset, Malmo, Sweden In a systematic search for a substance with anti- arbitrary urokinase units by reference to a standard fibrinolytic properties Okamoto and his group in urokinase preparation.'0 11 Japan found that several mercapto- and amino- Intravenous administration of 10 g EACA or carbonic acids were active. Of these substances 100 mg EACA/kg bodyweight produces an initial epsilon-aminocaproic acid (EACA) had the strong- serum concentration of about 150 mg/100 ml which est antifibrinolytic effect.1 2 The Japanese workers falls to 3 5 mg/100 ml within 3-4 hours (Fig. 1). described it as a plasmin inhibitor in vitro and The biological half life was calculated to be about 77 useful in inhibiting proteolytic enzymes in vivo. They minutes. Andersson et al.8 found that about 70 % of gave EACA in a dose of 10-20 g a day by mouth or the dose given intravenously was excreted in the intravenously to over 100 patients and observed no urine within 24 hours (Fig. 2). McNicol et al.7 toxic effects. Their investigation did not include any found 80-100I% of the given dose in the urine metabolic studies. EACA has since been widely used within 4-6 hours. The EACA is thus concentrated and its mode of action and pharmacokinetics intensively studied.
    [Show full text]
  • Novel T 2019 Vol 3 2.0.Indd
    Novel Treatments in Haemophilia & Other Bleeding Disorders: A Periodic Review 2019 - Issue 2 Irish Haemophilia Society haemophilia.ie October 2019 Contents Foreword Page 03 Abbreviations Page 04 An update on novel treatments for haemophilia A Page 05 Replacement therapies Page 05 Non-replacement therapies Page 08 Gene therapy Page 11 A comment on gene therapy Page 14 An update on novel treatments in haemophilia B Page 15 Replacement therapies Page 15 Non-replacement therapies Page 16 Gene therapy Page 16 A comment on PEG: Same data, same discussion, different regulatory decisions Page 18 An update on novel therapies for inhibitor treatment Page 20 By-passing therapies Page 20 Non-replacement therapies Page 20 Gene therapy Page 22 An update on novel therapies for von Willebrand disease Page 22 An update on novel therapies for rare bleeding disorders Page 23 Disclaimer: This publication is produced by the European Haemophilia Consortium (EHC) primarily as an educational tool for National Member Organisations (NMOs). With the constantly changing therapeutic environment, it is our intention to publish updates on a periodic basis. The information contained, and the views expressed herein constitute the collective input of the EHC New Products Working Group. The EHC does not engage in medical practice and under no circumstances recommends particular treatment for specifi c individuals. The EHC makes no representation, express or implied, that drug doses or other treatment recommendations in this publication are correct. For these reasons it is strongly recommended that individuals seek the advice of a medical adviser and/or consult printed instructions provided by the pharmaceutical company before administering any of the drugs referred to in this publication.
    [Show full text]
  • Tranexamic Acid (4.2) These Highlights Do Not Include All the Information Needed to Use LYSTEDA Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION Hypersensitivity to tranexamic acid (4.2) These highlights do not include all the information needed to use LYSTEDA safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS------------------------ LYSTEDA. Concomitant use of LYSTEDA with Factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral LYSTEDA™ (tranexamic acid) Tablets tretinoin) may increase the risk of thrombosis. (5.1) Initial U.S. Approval: 1986 Visual or ocular adverse effects may occur with LYSTEDA. Immediately discontinue use if visual or ocular symptoms occur. (5.1) ---------------------------------RECENT MAJOR CHANGES--------------------- In case of severe allergic reaction, discontinue LYSTEDA and seek Contraindications (4.1) 10/2013 immediate medical attention. (5.2) Warnings and Precautions (5.1) 10/2013 Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage. (5.3) Ligneous conjunctivitis has been reported in patients taking tranexamic ----------------------------INDICATIONS AND USAGE--------------------------- acid. (5.4) LYSTEDA (tranexamic acid) Tablets is an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding. (1) ------------------------------ADVERSE REACTIONS------------------------------- Most common adverse reactions in clinical trials (≥ 5%, and more frequent in ----------------------DOSAGE AND ADMINISTRATION----------------------- LYSTEDA
    [Show full text]
  • Antifibrinolytic Therapy in Cardiac Surgery
    Antifibrinolysis and Blood-Saving Antifibrinolytic Therapy Techniques in Cardiac Surgery Ray H. Chen, MD Bleeding remains an important complication after repeat and complicated cardiac sur- O.H. Frazier, MD gery. Although aprotinin has recently been approved by the Food and Drug Administra- Denton A. Cooley, MD tion for use as an antifibrinolytic agent, many surgeons continue to have concerns about its added cost and potential side effects. We review here the current state of anti- fibrinolytic therapy for excessive bleeding in cardiothoracic surgery and suggest the use of a single intravenous dose of 10 g of e-aminocaproic acid immediately before cardio- pulmonary bypass as a safe, inexpensive, and effective alternative to aprotinin. Further clinical and laboratory studies are needed to confirm or modify this protocol. (Tex Heart Inst J 1995;22:211-5) B leeding continues to be a significant complication after cardiac surgery, even in the current, state-of-the-art, surgical practice. Public apprehension of transfusion-related communicable diseases, particularly acquired im- munodeficiency syndrome, has refocused the attention of cardiac surgeons on the importance of hemostasis to minimize the need for, and therefore the risks of, blood transfusion.'"3 Recent approval by the Food and Drug Administration of aprotinin as an agent for reducing blood loss during surgery has generated enthusiasm among cardiac surgeons. However, the use of aprotinin in routine practice has not been widely accepted because of the added cost, the risk of anaphylactic reaction, and the potential for increased incidence of postoperative myocardial infarction and graft thrombosis.47 Because both laboratory and clinical data support fibrinolysis as the mecha- nism of postoperative bleeding in open-heart surgery,"'2 the use of an antifibrino- lytic agent seems appropriate.
    [Show full text]