Management of Surgical Hemostasis an Independent Study Guide
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Recombinant Factors for Hemostasis
University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Chemical & Biomolecular Engineering Theses, Chemical and Biomolecular Engineering, Dissertations, & Student Research Department of Summer 2010 Recombinant Factors for Hemostasis Jennifer Calcaterra University of Nebraska at Lincoln, [email protected] Follow this and additional works at: https://digitalcommons.unl.edu/chemengtheses Part of the Biochemical and Biomolecular Engineering Commons Calcaterra, Jennifer, "Recombinant Factors for Hemostasis" (2010). Chemical & Biomolecular Engineering Theses, Dissertations, & Student Research. 5. https://digitalcommons.unl.edu/chemengtheses/5 This Article is brought to you for free and open access by the Chemical and Biomolecular Engineering, Department of at DigitalCommons@University of Nebraska - Lincoln. It has been accepted for inclusion in Chemical & Biomolecular Engineering Theses, Dissertations, & Student Research by an authorized administrator of DigitalCommons@University of Nebraska - Lincoln. Recombinant Factors for Hemostasis by Jennifer Calcaterra A DISSERTATION Presented to the Faculty of The Graduate College at the University of Nebraska In Partial Fulfillment of Requirements For the Degree of Doctor of Philosophy Major: Interdepartmental Area of Engineering (Chemical & Biomolecular Engineering) Under the Supervision of Professor William H. Velander Lincoln, Nebraska August, 2010 Recombinant Factors for Hemostasis Jennifer Calcaterra, Ph.D. University of Nebraska, 2010 Adviser: William H. Velander Trauma deaths are a result of hemorrhage in 37% of civilians and 47% military personnel and are the primary cause of death for individuals under 44 years of age. Current techniques used to treat hemorrhage are inadequate for severe bleeding. Preliminary research indicates that fibrin sealants (FS) alone or in combination with a dressing may be more effective; however, it has not been economically feasible for widespread use because of prohibitive costs related to procuring the proteins. -
TACHOSIL (Fibrin Sealant Patch)
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM To: Craig Zinderman, MD, MPH Acting Director, Division of Epidemiology (DE) Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER) Through: Meghna Alimchandani, MD Associate Director for Medical Policy, OBE, CBER From: Faith Barash, MD, MPH Medical Officer, Pharmacovigilance Branch Office of Biostatistics and Epidemiology (OBE) Center for Biologics Evaluation and Research (CBER) Subject: Safety and Utilization Review for the Pediatric Advisory Committee Applicant: Takeda Pharma A/S Product: TACHOSIL (Fibrin Sealant Patch) STN: 125351/279 Indication: TACHOSIL is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Meeting Date: Pediatric Advisory Committee Meeting, September 2019 1 Contents 1 INTRODUCTION ................................................................................................................................ 3 1.1 Objective ...................................................................................................................................... 3 1.2 Product Description .................................................................................................................... 3 1.3 Regulatory -
Usefulness of the Harmonic Scalpel in Thyroid Surgery
ORIGINAL ISSN: 2005-162X J Korean Thyroid Assoc 2012 November 5(2): 138-142 ARTICLE http://dx.doi.org/10.11106/jkta.2012.5.2.138 Usefulness of the Harmonic Scalpel in Thyroid Surgery Hwan Choe, Kwang-Yoon Jung, Soon-Young Kwon, Jeong-Soo Woo, Min Woo Park and Seung-Kuk Baek Department of Otolaryngology-Head and Neck Surgery, Korea University College of Medicine, Seoul, Korea Background and Objectives: The harmonic scalpel using the ultrasonic energy is able to grasp and divide tissue while sealing small vessels in narrow operating fields. The aim of the present study was to evaluate the usefulness of the harmonic scalpel in thyroid surgery. Materials and Methods: This study was performed for 247 patients who underwent thyroidectomy. According to the use of harmonic Scalpel, the patients could be divided into two groups: the conventional technique (CT) group of knot tying and the harmonic scalpel (HS) group. Results: For hemithyroidectomy, operation time and hospital stay were shorter in the HS group compared with the CT group (p<0.05). For total thyroidectomy with central neck dissection (CND), operation time, total drainage volume, drain removal date, and hospital stay were significantly reduced in the HS group (p<0.05). Among the patients who underwent total thyroidectomy with CND with the HS, one patient (2.9%) showed transient recurrent laryngeal nerve palsy. Transient hypoparathyroidism showed significantly lower incidence in the HS group (p<0.05). Conclusion: HS might be cost-effective by reducing operation time and hospital stay -
Cleaning, Disinfection and Sterilization Guide
CLEANING, DISINFECTION AND STERILIZATION GUIDE Revision 5.2 Copyright 2016, Brainlab AG Germany. All rights reserved. TABLE OF CONTENTS TABLE OF CONTENTS GENERAL INFORMATION...................................................................................................7 Contact Data and Legal Information......................................................................................................7 Contact Data................................................................................................................................................7 Legal Information .........................................................................................................................................8 Symbols .......................................................................................................................................................9 Symbols Used in This Guide ........................................................................................................................9 Hardware Symbols.....................................................................................................................................10 Hardware....................................................................................................................................................13 Using the Hardware ...................................................................................................................................13 Documentation .........................................................................................................................................14 -
Monitoring International Trends Posted May 2016
Monitoring International Trends posted May 2016 The NBA monitors international developments that may influence the management of blood and blood products in Australia. Our focus is on: Potential new product developments and applications; Global regulatory and blood practice trends; Events that may have an impact on global supply, demand and pricing, such as changes in company structure, capacity, organisation and ownership; and Other emerging risks that could potentially put financial or other pressures on the Australian sector. A selection of recent matters of interest appears below. Highlights include: BioMarin Pharmaceutical released preliminary data on its investigational gene therapy treatment for haemophilia A. (Section 1) Data on Bluebird bio’s gene therapy in severe sickle cell disease and transfusion- dependent β-thalassemia was discussed at the American Society of Gene & Cell Therapy Annual Meeting. (Section 1) Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension to the marketing authorisation for Baxalta’s subcutaneous immunoglobulin, HyQvia. (Section 2) NovoNordisk submitted to the US Food and Drug Administration (FDA) a Biologics License Application for its long-acting factor IX. (Section 2) The European Commission approved Swedish Orphan Biovitrum and Biogen’s recombinant factor IX Fc Fusion protein therapy. (Section 2) The FDA granted seven years of marketing exclusivity for CSL Behring's Coagulation Factor IX (Recombinant), Albumin Fusion Protein, with an extended dosing interval]. (Section 2) In Australia, the Therapeutic Goods Administration (TGA) approved a monoclonal antibody that reverses the anticoagulant effect of dabigatran in patients who require emergency surgery or have life-threatening bleeding. -
Minutes of PRAC Meeting on 09-12 July 2018
6 September 2018 EMA/PRAC/576790/2018 Inspections, Human Medicines Pharmacovigilance and Committees Division Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of the meeting on 09-12 July 2018 Chair: June Raine – Vice-Chair: Almath Spooner Health and safety information In accordance with the Agency’s health and safety policy, delegates were briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in the minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scope listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also change during the course of the review. Additional details on some of these procedures will be published in the PRAC meeting highlights once the procedures are finalised. Of note, the minutes are a working document primarily designed for PRAC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006, Rev. 1). 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2018. -
The Basic Surgery Kit
GLOBAL EXCLUSIVE > SURGERY > PEER REVIEWED The Basic Surgery Kit Jan Janovec, MVDr, MRCVS VRCC Veterinary Referrals Laurent Findji, DMV, MS, MRCVS, DECVS Fitzpatrick Referrals Considering the virtually limitless range of surgical instruments, it can be difficult to assemble a cost-effective basic surgery kit. Some instruments may misleadingly appear multipurpose, but their misuse may damage them, leading to unnecessary replacement costs or, worse, intraoperative accidents putting the patient’s safety at risk. Many instru- ments are available in different qualities and materials (eg, tungsten carbide instruments— more expensive but much more resistant to wear and corrosion than stainless steel) and Minimal Basic Surgery Kit varied sizes to match the purpose of their use as well as the size of the surgeon’s hand. n 1 instrument case Cutting Instruments n 1 scalpel handle Scalpel n 1 pair Mayo scissors The scalpel is an indispensible item in a surgical kit designed to make sharp incisions. Scalpel incision is the least traumatic way of dissection, but provides no hemostasis. n 1 pair Metzenbaum scissors Scalpel handles come in various sizes, each accommodating a range of disposable n 1 pair suture scissors blades (Figure 1). Entirely disposable scalpels are also available. n 1 pair Mayo-Hegar needle holder Scissors n 1 pair Brown-Adson tissue forceps Scissors are used for cutting, albeit with some crushing effect, and for blunt dissection. n 1 pair DeBakey tissue forceps Fine scissors, such as Metzenbaum scissors (Figure 2), should be reserved for cutting n 4 pairs mosquito hemostatic forceps and dissecting delicate tissues. Sturdier scissors, such as Mayo or suture scissors, are designed for use on denser tissues (eg, fascia) or inanimate objects (eg, sutures, drapes). -
The Effect of Chitosan Dextran Gel As a Haemostatic and Anti-Adhesion
THE EFFECT OF CHITOSAN DEXTRAN GEL AS A HAEMOSTATIC AND ANTI ADHESION AGENT IN THE CENTRAL NERVOUS SYSTEM AND EVALUATION OF HAEMOSTATIC MECHANISM OF SKELETAL MUSCLE TISSUE Thesis submitted in March 2015 for The degree of Doctor of Philosophy In the University of Adelaide By Sukanya Rajiv, M.B.B.S, M.S The work described in this thesis was performed within The Department of Surgery Otolaryngology, Head and Neck Surgery, The University of Adelaide 1 Table of Contents TITLE PAGE________________________________________ 1 ABSTRACT________________________________________ 5 INTRODUCTION____________________________________________ 5 METHODS_________________________________________________ 5 RESULTS__________________________________________________ 7 CONCLUSION___________________________________________ 7 DECLARATION________________________________________ 9 PREFACE_____________________________________________ 10 ACKNOWLEDGEMENTS_______________________________ 11 CHAPTER 1 AIMS_____________________________________ 13 CHAPTER 2 INTRODUCTION_______________________________ 15 CHAPTER 3 NORMAL HAEMOSTASIS______________________ 21 BLOOD VESSEL/ ENDOTHELIAL CELL___________________________ 22 PLATELETS___________________________________________________ 25 COAGULATION CASCADE______________________________________ 27 INHIBITORS OF COAGULATION_________________________________ 28 FIBRINOLYTIC SYSTEM________________________________________ 29 COAGULATION SCREEN TESTS_________________________________ 30 CHAPTER 4 HEMOSTATIC TECHNIQUES IN CENTRAL NERVOUS SYSTEM___________________________________ -
Hematopoiesis and Hemostasis
Hematopoiesis and Hemostasis HAP Susan Chabot Hematopoiesis • Blood Cell Formation • Occurs in red bone marrow – Red marrow - found in flat bones and proximal epiphyses of long bones. • Each type of blood cell is produced in response to changing needs of the body. • On average, an ounce of new blood is produced each day with about 100 billion new blood cells/formed elements. Hemocytoblast • Hemo- means blood • Cyto- means cell • -blast means builder • Blood stem cell found in red bone marrow. • Once the precursor cell has committed to become a specific blood type, it cannot be changed. Hemocytoblast Erythropoiesis • Erythrocyte Formation • Because they are anucleated, RBC’s must be regularly replaced. – No info to synthesize proteins, grow or divide. • They begin to fall apart in 100 - 120 days. • Remains of fragmented RBC’s are removed by the spleen and liver. • Entire development , release, and ejection of leftover organelles takes 3-5 days. Normal RBC’s Reticulocytes • The stimulus for RBC production is the amount of OXYGEN in the blood not the NUMBER of RBC’s. • The rate of RBC production is controlled by the hormone ERYTHROPOIETIN. Leuko- and Thrombopoiesis • Leukopoesis = WBC production • Thrombopoesis = platelet production • Controlled by hormones Leukopoesis Thrombopoesis • (CSF) Colony • Thrombopoetin stimulating factor • Little is known • Interleukins about this – Prompts WBC process. production – Boosts other immune processes including inflammation. HEMOSTASIS Hemostasis • Hemo- means blood • -stasis means standing still – Stoppage of bleeding • Fast and localized reaction when a blood vessel breaks. • Involves a series of reactions. • Involves substances normally found in plasma but not activated. • Occurs in 3 main phases Phases of Hemostasis • Step 1: Vascular Spasm – Vasoconstriction, narrowing of blood vessels. -
Notch and TLR Signaling Coordinate Monocyte Cell Fate and Inflammation
RESEARCH ARTICLE Notch and TLR signaling coordinate monocyte cell fate and inflammation Jaba Gamrekelashvili1,2*, Tamar Kapanadze1,2, Stefan Sablotny1,2, Corina Ratiu3, Khaled Dastagir1,4, Matthias Lochner5,6, Susanne Karbach7,8,9, Philip Wenzel7,8,9, Andre Sitnow1,2, Susanne Fleig1,2, Tim Sparwasser10, Ulrich Kalinke11,12, Bernhard Holzmann13, Hermann Haller1, Florian P Limbourg1,2* 1Vascular Medicine Research, Hannover Medical School, Hannover, Germany; 2Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany; 3Institut fu¨ r Kardiovaskula¨ re Physiologie, Fachbereich Medizin der Goethe-Universita¨ t Frankfurt am Main, Frankfurt am Main, Germany; 4Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, Hannover Medical School, Hannover, Germany; 5Institute of Medical Microbiology and Hospital Epidemiology, Hannover Medical School, Hannover, Germany; 6Mucosal Infection Immunology, TWINCORE, Centre for Experimental and Clinical Infection Research, Hannover, Germany; 7Center for Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany; 8Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany; 9German Center for Cardiovascular Research (DZHK), Partner Site Rhine Main, Mainz, Germany; 10Department of Medical Microbiology and Hygiene, Medical Center of the Johannes Gutenberg- University of Mainz, Mainz, Germany; 11Institute for Experimental Infection Research, TWINCORE, Centre for -
Human Alveolar Macrophages Synthesize Factor VII in Vitro
Human alveolar macrophages synthesize factor VII in vitro. Possible role in interstitial lung disease. H A Chapman Jr, … , O L Stone, D S Fair J Clin Invest. 1985;75(6):2030-2037. https://doi.org/10.1172/JCI111922. Research Article Both fibrin and tissue macrophages are prominent in the histopathology of chronic inflammatory pulmonary disease. We therefore examined the procoagulant activity of freshly lavaged human alveolar macrophages in vitro. Intact macrophages (5 X 10(5) cells) from 13 healthy volunteers promoted clotting of whole plasma in a mean of 65 s. Macrophage procoagulant activity was at least partially independent of exogenous Factor VII as judged by a mean clotting time of 99 s in Factor VII-deficient plasma and by neutralization of procoagulant activity by an antibody to Factor VII. Immunoprecipitation of extracts of macrophages metabolically labeled with [35S]methionine by Factor VII antibody and analyzed by sodium dodecyl sulfate-polyacrylamide gel electrophoresis revealed a labeled protein consistent in size with the known molecular weight of blood Factor VII, 48,000. The addition of 50 micrograms of unlabeled, purified Factor VII blocked recovery of the 48,000-mol wt protein. In addition, supernatants of cultured macrophages from six normal volunteers had Factor X-activating activity that was suppressed an average of 71% after culture in the presence of 50 microM coumadin or entirely by the Factor VII antibody indicating that Factor VII synthesized by the cell was biologically active. Endotoxin in vitro induced increases in cellular tissue factor but had no consistent effect on macrophage Factor VII activity. We also examined the tissue factor and Factor VII activities […] Find the latest version: https://jci.me/111922/pdf Human Alveolar Macrophages Synthesize Factor VII In Vitro Possible Role in Interstitial Lung Disease Harold A. -
Management of Bleeding and Coagulopathy Following Major Trauma
Spahn et al. Critical Care 2013, 17:R76 http://ccforum.com/content/17/2/R76 RESEARCH Open Access Management of bleeding and coagulopathy following major trauma: an updated European guideline Donat R Spahn1, Bertil Bouillon2, Vladimir Cerny3,4, Timothy J Coats5, Jacques Duranteau6, Enrique Fernández-Mondéjar7, Daniela Filipescu8, Beverley J Hunt9, Radko Komadina10, Giuseppe Nardi11, Edmund Neugebauer12, Yves Ozier13, Louis Riddez14, Arthur Schultz15, Jean-Louis Vincent16 and Rolf Rossaint17* Abstract Introduction: Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved. Methods: The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results: Key changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients.