CCEMS Whole Blood Protocol
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Stem Cells and Artificial Substitutes Could Ease the Dependence on Blood Donations
OUTLOOK BLOOD DOING WITHOUT DONORS Stem cells and artificial substitutes could ease the dependence on blood donations. ANDREW BAKER BY ELIE DOLGIN S12 | NATURE | VOL 549 | 28 SEPTEMBER©2017 Ma c2017millan Publishers Li mited, part of Spri nger Nature. All ri ghts reserved. ©2017 Mac millan Publishers Li mited, part of Spri nger Nature. All ri ghts reserved. BLOOD OUTLOOK ach year, at about 13,000 collection centres worldwide, phlebotomists stick needles in the veins of healthy vol- unteers and amass in excess of 110 million donations of blood. The volume collected is enough to fill 20 Olympic- sized swimming pools — but it’s nowhere near to meeting the medical demand for whole blood or its components. To fill the gap, an enterprising group of stem-cell biologists and bio- Eengineers hopes to produce a safe, reliable and bottomless supply of on-demand blood substitutes in the laboratory. According to Robert Lanza, a pioneer of stem cell therapies and head IMAGES IWM VIA GETTY CHETWYN/ SGT. of global regenerative medicine at Astellas Pharma in Marlborough, Massachusetts, current technologies are not yet ready to compete with the real stuff. “We’re not going to put blood banks out of business any time soon,” he says. But in the near future, artificial blood products could be approved for use when transfusions are not otherwise an option, such as during combat or in people with a religious objection to receiving blood transfusions. And therapies that rely on reprogrammed stem cells to produce components of blood might also help transfusion centres to relieve shortages or to avoid donor-derived contamination. -
Blood Product Replacement: Obstetric Hemorrhage
CMQCC OBSTETRIC HEMORRHAGE TOOLKIT Version 2.0 3/24/15 BLOOD PRODUCT REPLACEMENT: OBSTETRIC HEMORRHAGE Richard Lee, MD, Los Angeles County and University of Southern California Medical Center Laurence Shields, MD, Marian Regional Medical Center/Dignity Health Holli Mason, MD, Cedars-Sinai Medical Center Mark Rollins, MD, PhD, University of California, San Francisco Jed Gorlin, MD, Innovative Blood Resources/Memorial Blood Center, St. Paul, Minnesota Maurice Druzin, MD, Lucile Packard Children’s Hospital Stanford University Jennifer McNulty, MD, Long Beach Memorial Medical Center EXECUTIVE SUMMARY • Outcomes are improved with early and aggressive intervention. • Both emergency blood release and massive transfusion protocols should be in place. • In the setting of significant obstetric hemorrhage, resuscitation transfusion should be based on vital signs and blood loss and should not be delayed by waiting for laboratory results. • Calcium replacement will often be necessary with massive transfusion due to the citrate used for anticoagulation in blood products. • During massive transfusion resuscitation, the patient’s arterial blood gas, electrolytes, and core temperature should be monitored to guide clinical management and all transfused fluids should be warmed; direct warming of the patient should be initiated as needed to maintain euthermia and to avoid added coagulopathy. BACKGROUND AND LITERATURE REVIEW After the first several units of packed red blood cells (PRBCs) and in the face of continuing or worsening hemorrhage, aggressive transfusion therapy becomes critical. This report covers the experience with massive transfusion protocols. Lessons from military trauma units as well as civilian experience with motor vehicle accidents and massive obstetric hemorrhage have identified new principles such as earlier use of plasma (FFP/thawed plasma/plasma frozen within 24 hours/liquid plasma) and resuscitation transfusion while laboratory results are pending. -
Platelet-Rich Plasmapheresis: a Meta-Analysis of Clinical Outcomes and Costs
THE jOURNAL OF EXTRA-CORPOREAL TECHNOLOGY Original Article Platelet-Rich Plasmapheresis: A Meta-Analysis of Clinical Outcomes and Costs Chris Brown Mahoney , PhD Industrial Relations Center, Carlson School of Management, University of Minnesota, Minneapolis, MN Keywords: platelet-rich plasmapheresis, sequestration, cardiopulmonary bypass, outcomes, economics, meta-analysis Presented at the American Society of Extra-Corporeal Technology 35th International Conference, April 3-6, 1997, Phoenix, Arizona ABSTRACT Platelet-rich plasmapheresis (PRP) just prior to cardiopulmonary bypass (CPB) surgery is used to improve post CPB hemostasis and to minimize the risks associated with exposure to allogeneic blood and its components. Meta-analysis examines evidence ofPRP's impact on clinical outcomes by integrating the results across published research studies. Data on clinical outcomes was collected from 20 pub lished studies. These outcomes, DRG payment rates, and current national average costs were used to examine the impact of PRP on costs. This study provides evidence that the use of PRP results in improved clinical outcomes when compared to the identical control groups not receiving PRP. These improved clinical out comes result in subsequent lower costs per patient in the PRP groups. All clinical outcomes analyzed were improved: blood product usage, length of stay, intensive care stay, time to extu bation, incidence of cardiovascular accident, and incidence of reoperation. The most striking differences occur in use of all blood products, particularly packed red blood cells. This study provides an example of how initial expenditure on technology used during CPB results in overall cost savings. Estimated cost savings range from $2,505.00 to $4,209.00. -
Blood Product Modifications: Leukofiltration, Irradiation and Washing
Blood Product Modifications: Leukofiltration, Irradiation and Washing 1. Leukocyte Reduction Definitions and Standards: o Process also known as leukoreduction, or leukofiltration o Applicable AABB Standards, 25th ed. Leukocyte-reduced RBCs At least 85% of original RBCs < 5 x 106 WBCs in 95% of units tested . Leukocyte-reduced Platelet Concentrates: At least 5.5 x 1010 platelets in 75% of units tested < 8.3 x 105 WBCs in 95% of units tested pH≥6.2 in at least 90% of units tested . Leukocyte-reduced Apheresis Platelets: At least 3.0 x 1011 platelets in 90% of units tested < 5.0 x 106 WBCs 95% of units tested pH≥6.2 in at least 90% of units tested Methods o Filter: “Fourth-generation” filters remove 99.99% WBCs o Apheresis methods: most apheresis machines have built-in leukoreduction mechanisms o Less efficient methods of reducing WBC content . Washing, deglycerolizing after thawing a frozen unit, centrifugation . These methods do not meet requirement of < 5.0 x 106 WBCs per unit of RBCs/apheresis platelets. Types of leukofiltration/leukoreduction o “Pre-storage” . Done within 24 hours of collection . May use inline filters at time of collection (apheresis) or post collection o “Pre-transfusion” leukoreduction/bedside leukoreduction . Done prior to transfusion . “Bedside” leukoreduction uses gravity-based filters at time of transfusion. Least desirable given variability in practice and absence of proficiency . Alternatively performed by transfusion service prior to issuing Benefits of leukoreduction o Prevention of alloimmunization to donor HLA antigens . Anti-HLA can mediate graft rejection and immune mediated destruction of platelets o Leukoreduced products are indicated for transplant recipients or patients who are likely platelet transfusion dependent o Prevention of febrile non-hemolytic transfusion reactions (FNHTR) . -
Which Is the Preferred Blood Product for Fibrinogen Replacement in The
SUPPLEMENT ARTICLE Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia— cryoprecipitate or fibrinogen concentrate? Melissa M. Cushing ,1 Thorsten Haas,2 Keyvan Karkouti,3,4 and Jeannie Callum5,6,7 PRO FIBRINOGEN CONCENTRATE: The importance of the targeted treatment of acquired FIBRINOGEN CONCENTRATE IS THE hypofibrinogenemia during hemorrhage with a PREFERRED BLOOD PRODUCT FOR concentrated fibrinogen product (either cryoprecipitate or FIBRINOGEN REPLACEMENT IN THE fibrinogen concentrate) cannot be underestimated. BLEEDING PATIENT WITH ACQUIRED Fibrinogen concentrate is a pathogen inactivated, pooled HYPOFIBRINOGENEMIA product that offers a highly purified single factor concentrate. Cryoprecipitate is a pooled product that hrough this section of our debate, we will attempt comes with a spectrum of other coagulation factors to convince you to abandon cryoprecipitate (if you which may further enhance (additional procoagulant have not already done so) for the management of effect) or even disturb (prothrombotic risk) hemostasis. hemorrhage in the presence of acquired hypo- Tfibrinogenemia (fibrinogen level less than 1.5-2.0 g/L). It is The pros and cons of each product are discussed. crucial for the safety of future generations of transfusion recip- ients that all blood products transfused are pathogen inactivated (where available, safe, and effective).1 Although there are numerous hurdles to the implementation of pathogen-inactivation technologies across all manufactured blood products -
An EU-Wide Overview of the Market of Blood, Blood Components and Plasma Derivatives Focusing on Their Availability for Patients
An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients Creative Ceutical Report, revised by the Commission to include stakeholders’ comments Acknowledgments The authors would like to thank the following organizations for their support in providing information, input and comments to build this project: The European Blood Alliance (EBA) We would like to specifically thank Dr Gilles Folléa, Executive Director of EBA for his valuable contribution. The European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe (CoE) We would like to specifically thank Dr. Marie Emmanuelle Behr-Gross and Dr. Guy Rautmann, the former and the current Secretary to the European Committee on Blood Transfusion of the EDQM/CoE for their valuable support and for sharing or facilitating access to unpublished data. The International Plasma Fractionation Association (IPFA) We would like to thank Dr Robert Perry, Consultant and former Executive Director and Paul Strengers, Executive President, for their valuable support in this project. The Plasma Protein Therapeutic Association (PPTA) We would like to specifically thank M. Jan Bult CEO and President of PPTA global, M. Charles Waller who acted as Senior Director, Health Policy of PPTA Europe and Ms Laura Savini, Manager National Affairs, for their valuable support in this project. The Plasma Users Coalition (PLUS) We would like to specifically thank M. Johan Prevot, member of the PLUS Steering committee and executive director of the International Patient Organization for Primary Immunodeficiencies for his valuable input to this project’s stakeholder consultation. National Competent Authorities We would like to thank the national competent authorities (NCA's) for inputs provided during NCA meetings and to Commission surveys which have been used in this report. -
PATIENT BLOOD MANAGEMENT in HEMATOLOGY and ONCOLOGY by Mark T
JULY 2020 PATIENT BLOOD MANAGEMENT IN HEMATOLOGY AND ONCOLOGY By Mark T. Friedman, DO Icahn School of Medicine, Mt. Sinai Patients undergoing treatment in hematology and oncology (hem/onc) departments are often some of the most challenging for transfusion medicine specialists. These patients are some of the highest users of blood products both in the inpatient and outpatient settings. At the same time, there is a dearth of scientific literature regarding transfusion medicine in this patient population, which has been a hinderance in developing best practice guidelines. For patients with cancer, anemia is frequently induced via direct (e.g., nutritional [iron and vitamin B12] deficiency, marrow infiltration, and coagulopathy-related bleeding) and indirect (e.g., anemia of chronic disease related to inflammation and autoimmune hemolytic anemia) effects.1 In addition, anemia and thrombocytopenia are two common side effects of cancer treatment (chemotherapy and radiation therapy). Nevertheless, strategies to minimize exposure to blood products should be considered in light of the risks and complications of blood transfusion. Long-term risks of alloimmunization, iron overload and transfusion-related immunomodulation (TRIM) are of special concern in patients receiving chronic transfusions. Patient blood management (PBM) strategies that may be employed to reduce transfusions in cancer patients in both the inpatient and outpatient settings are the focus of this column. There are PBM strategies common to all patients that can be applied to hem/onc patients. Adherence to stricter transfusion guidelines, including the use of a hemoglobin level closer to 7.0 g/dL as the transfusion trigger for stable patients with anemia, as well as transfusion of single rather than multiple RBC units in nonbleeding patients, is recommended. -
Clinical Transfusion Practice
Clinical Transfusion Practice Guidelines for Medical Interns Foreword Blood transfusion is an important part of day‐to‐day clinical practice. Blood and blood products provide unique and life‐saving therapeutic benefits to patients. However, due to resource constraints, it is not always possible for the blood product to reach the patient at the right time. The major concern from the point of view of both user (recipient) and prescriber (clinician) is for safe, effective and quality blood to be available when required. Standard practices should be in place to include appropriate testing, careful selection of donors, screening of donations, compatibility testing, storage of donations for clinical use, issue of blood units for either routine or emergency use, appropriate use of blood supplied or the return of units not needed after issue, and reports of transfusion reactions – all are major aspects where standard practices need to be implemented. In order to implement guidelines for standard transfusion practices, a coordinated team effort by clinicians, blood transfusion experts, other laboratory personnel and health care providers involved in the transfusion chain, is needed. Orientation of standard practices is vital in addressing these issues to improve the quality of blood transfusion services. Bedside clinicians and medical interns are in the forefront of patient management. They are responsible for completing blood request forms, administering blood, monitoring transfusions and being vigilant for the signs and symptoms of adverse reactions. -
7342.002: Inspection of Source Plasma Establishments, Brokers
Compliance Program Guidance Manual Chapter 42 – Blood and Blood Components Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002 Implementation Date: 6/1/2016 Completion Date: 1/31/2019 57DI-44 Source Plasma Product Codes: 57DI-55 Source Leukocytes Human 57DI-65 Therapeutic Exchange Plasma (TEP) 42002F Source Plasma Level 1 Inspection (all systems) Program Assignment Codes (PACs): 42002G Source Plasma Level 2 Inspection (two systems) 42002A Pre-License 42832 Pre-Approval In a Federal Register notice dated May 22, 2015 (80 FR 29842), the Food and Drug Administration (FDA) announced changes to the regulations for blood and blood components including Source Plasma that became effective on May 23, 2016. These changes were made, in part, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. Among other updates and changes to this Compliance Program, the following Attachments have been substantially revised to include the new requirements: Attachment C – Donor Eligibility System – Donor Screening & Deferral Attachment D – Product Testing System – Transfusion-Transmitted Infections (Relevant Transfusion Transmitted Infection(s)) Attachment F – Quarantine/Storage/Disposition – Donation Suitability, Restrictions on Distribution, Hold FIELD REPORTING REQUIREMENTS A. General FDA/Office of Regulatory Affairs -
IG-002 United States Consensus Standard for the Uniform
United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 Tracking Number ICCBBA IG-002 Published by: ICCBBA PO Box 11309, San Bernardino, CA 92423 USA Telephone: +1 (909)793-6516 Fax: +1 (909) 793-6214 E-mail: [email protected] Website: www.iccbba.org US Consensus Standard, Version 3.0.0 1 Acknowledgement ICCBBA thanks the members of the Americas Technical Advisory Group (ATAG) for their contributions in the development of this consensus standard. Members of ATAG Suzy Grabowski, Chair Suzanne Butch Guilherme Genovez Donald Gironne Sharon McMillan Dan Simpson Representatives Karen Burns, Veteran’s Administration Nikki Denlinger, American Red Cross Peggy Dunn, AABB Simon Fournier, HémaQuébec Lora Poore, Americas Blood Centers Dorothy Ward, Canadian Blood Services Liaisons Francisca Agbanyo, Health Canada Jennifer Jones, FDA Additionally, ICCBBA thanks the many observers who routinely participate in ATAG and provide valuable input. For reviewing and proof reading this document, ICCBBA thanks Jessica Youngblood, Oklahoma Blood Institute © 2013 ICCBBA All rights reserved www.iccbba.org US Consensus Standard, Version 3.0.0 2 Editor Pat Distler, MS, MT(ASCP)SBB Technical Director, ICCBBA Standards Committee John Armitage, Prof., BSc, PhD United Kingdom Paul Ashford, MSc. CEng. CSci. ICCBBA Wayne Bolton, B.App.Sc., M.App.Sc Australia Suzanne Butch, MA, MT(ASCP)SBB United States of America Pat Distler, MS, MT(ASCP)SBB ICCBBA Jørgen Georgsen, MD Denmark Suzy Grabowski, -
Administration of Blood Components
Administration of blood components Tina Parker - Transfusion Practitioner Red Cells • Each unit contains 250-350mls • Preserved with glucose and Mannitol to keep the correct tension • Lasts 35 days from midnight of donation day to midnight on expiry date • Must be given via a blood administration set (170-200micron ) • Can be given stat in an emergency but usually 2 hours or 2-3 hours if co-morbidities present • Must be completed within 4 hours from the time the unit is removed from the blood bank • The giving set must be changed if any other fluids than saline have been given prior to this unit, if then transfusing other blood components following this unit then it also needs to be changed Reasons for Red Blood Cell transfusion • Anaemia – chronic or acute • Solid tumours - haematological malignancies, peptic ulcer and other GI conditions • Myelodysplasia anaemia of chronic disease poor nutrition and treatment with chemotherapy and/or radiotherapy • Investigations should be undertaken to determine the underlying cause • Transfusions should be avoided in patients with B12 and folate deficiencies as the correct treatment with either B12 or folate can correct these without exposure to a blood product • Massive bleed – trauma, GI bleed etc Platelets • Straw coloured Kept at room temperature in an agitator Check the colour and consistency Should be started within 30 minutes of removal from the laboratory Complete within 20-30 minutes Does not have to be ABO compatible Reasons for Platelet transfusion • Acute leukaemia patients • Chronic stable -
Practice Guidelines for Perioperative Blood Management an Updated Report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*
PRACTICE PARAMETERS Practice Guidelines for Perioperative Blood Management An Updated Report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management* RACTICE guidelines are systematically developed rec- • What other guidelines are available on this topic? ommendations that assist the practitioner and patient in o These Practice Guidelines update “Practice Guidelines for P Perioperative Blood Transfusion and Adjuvant Therapies: An making decisions about health care. These recommendations Updated Report by the American Society of Anesthesiolo- may be adopted, modified, or rejected according to clinical gists Task Force on Perioperative Blood Transfusion and Ad- needs and constraints, and are not intended to replace local juvant Therapies” adopted by the American Society of Anes- thesiologists (ASA) in 2005 and published in 2006.1 institutional policies. In addition, practice guidelines devel- o Other guidelines on the topic for the management of blood oped by the American Society of Anesthesiologists (ASA) are transfusion have been published by the ASA, American College not intended as standards or absolute requirements, and their of Cardiology/American Heart Association,2 Society of Thoracic 3 use cannot guarantee any specific outcome. Practice guidelines Surgeons, Society of Cardiovascular Anesthesiologists, and the American Association of Blood Banks.4 The field of Blood Con- are subject to revision as warranted by the evolution of medi- servation has advanced considerably since the publication of the cal knowledge, technology, and practice. They provide basic ASA Guidelines for Transfusion and Adjuvant Therapies in ANES- recommendations that are supported by a synthesis and analy- THESIOLOGY in 2006. sis of the current literature, expert and practitioner opinion, • Why was this guideline developed? o In October 2012, the Committee on Standards and Practice open forum commentary, and clinical feasibility data.