Abuse of Fresh Frozen Plasma
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27. Clinical Indications for Cryoprecipitate And
27. CLINICAL INDICATIONS FOR CRYOPRECIPITATE AND FIBRINOGEN CONCENTRATE Cryoprecipitate is indicated in the treatment of fibrinogen deficiency or dysfibrinogenaemia.1 Fibrinogen concentrate is licenced for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia,2 and is currently funded under the National Blood Agreement. Key messages y Fibrinogen is an essential component of the coagulation system, due to its role in initial platelet aggregation and formation of a stable fibrin clot.3 y The decision to transfuse cryoprecipitate or fibrinogen concentrate to an individual patient should take into account the relative risks and benefits.3 y The routine use of cryoprecipitate or fibrinogen concentrate is not advised in medical or critically ill patients.2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In the setting of major obstetric haemorrhage, early administration of cryoprecipitate or fibrinogen concentrate may be necessary.3 Clinical implications y The routine use of cryoprecipitate or fibrinogen concentrate in medical or critically ill patients with coagulopathy is not advised. The underlying causes of coagulopathy should be identified; where transfusion is considered necessary, the risks and benefits should be considered for each patient. Specialist opinion is advised for the management of disseminated intravascular coagulopathy (MED-PP18, CC-PP7).2,4 y Cryoprecipitate or fibrinogen concentrate may be indicated in critical bleeding if fibrinogen levels are not maintained using FFP. In patients with critical bleeding requiring massive transfusion, suggested doses of blood components is 3-4g (CBMT-PP10)3 in adults or as per the local Massive Transfusion Protocol. -
Blood Products for Neonatal Transfusion
Blood Products for Neonatal Transfusion Transfusion of Red Cell Products A. Red cells for topup transfusion Pedipaks should be used for all red cell topup transfusions in infants. One blood donation is split into four equal volumes (approximately 50ml) and 2 or 4 packs are reserved for an individual baby, depending on weight. The use of pedipaks enables us to minimise patient exposure to multiple donors. Pedipak specifications: • Available in O Positive and O Negative • CMV Negative • Leucocyte Depleted • Suitable for topup transfusion until expiry (42 days from collection) • Commence transfusion within 30 minutes of product receipt Pedipaks and complete transfusion within 4 hours of spiking pack. Volume to be infused: Routine – 15 20ml/Kg over 4 hours. Infants may require IV Frusemide (per RWH Drug Manual) half way through the transfusion – discuss with neonatologist/fellow Emergency – larger volume over shorter time period depending on condition of infant. B. Red cells for Exchange Transfusion Exchange transfusion is generally carried out for hyperbilirubinaemia and/or anaemia usually due to haemolytic disease of the newborn (HDN) or prematurity. ARCBS produces a red cell product specifically for neonatal exchange transfusion. This red cell product has the following specifications: • Group O Negative • Kell negative • CMV negative • Leucocyte Depleted • Fresh (<=5 days) • Known haematocrit (<0.6) • Irradiated at ARCBS (should be transfused within 24 hours of irradiation) • Commence transfusion within 30 minutes of product receipt and complete transfusion within 4 hours of spiking pack. Transfusion of Albumin Volume to be infused: • 4% Albumin as a volume expander. 10 – 20ml/Kg over 30 – 60 minutes • 20% Albumin used for hypoalbuminaemia. -
Clinical Pharmacology of Infusion Fluids
Clinical pharmacology of infusion fluids Robert G. Hahn Linköping University Post Print N.B.: When citing this work, cite the original article. Original Publication: Robert G. Hahn , Clinical pharmacology of infusion fluids, 2012, Acta Medica Lituanica, (19), 3. Licencee: Lithuanian Academy of Sciences http://www.lmaleidykla.lt/ojs/index.php/actamedicalituanica/index Postprint available at: Linköping University Electronic Press http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-91319 ACTA MEDICA LITUANICA. 2012. Vol. 19. No. 3. P. 210–212 © Lietuvos mokslų akademija, 2012 Clinical pharmacology of infusion fluids Robert G. Hahn Fluids are used for intravenous infusion during practically all surgeries, but several different compositions are available on the market. Södertälje Hospital, Crystalloid fluids comprise lactated or acetated Ringer solutions, nor- Södertälje, Sweden; mal saline, Plasma-Lyte, hypertonic saline, and glucose. They lack allergic Anaesthesia and properties but are prone to cause peripheral tissue oedema. Their turn- Intensive Care, over is governed by physiological factors such as dehydration and drug Linköping University, effects. Sweden Colloid fluids include hydroxyethyl starch, albumin, dextran, and gela- tin. These fluids have various degrees of allergic properties and do not promote peripheral oedema. Their half-life is usually about hours. Factors increasing the turnover rate are poorly known but might include inflam- matory states. Current debates include the widespread use of normal saline, which should be replaced by Ringer’s or Plasma-Lyte in most situations, and the kidney damage associated with the use of starch in septic patients. New studies show that hypertonic saline does not improve survival or neuro- logical damage in prehospital care. -
FDA Regulation of Blood and Blood Components in the United States
FDA Regulation of Blood and Blood Components in the United States SLIDE 1 This presentation will review the FDA Regulation of Blood and Blood Components in the U.S. SLIDE 2 The FDA Center for Biologics Evaluation and Research, or CBER, Office of Blood Research and Review, called OBRR, reviews several different types of regulatory applications with respect to blood and blood components. This includes biologics license applications, called BLAs, which represent the regulatory pathway for blood components. The BLA regulatory process also applies to biological drugs such as fractionated plasma products. OBRR also regulates in-vitro diagnostic devices used for screening of collected blood, and does so also using the BLA regulatory pathway. Review of these devices as biologic licenses allows CBER to apply a higher level of manufacturing oversight, including lot release testing and pre-licensure inspection. This regulatory pathway applies to infectious disease tests for blood screening, as well as blood grouping and phenotyping reagents. SLIDE 3 The regulatory pathway for New Drug Applications, or NDAs, is most commonly used within the Center for Drug Evaluation and Research, or CDER. Within the Office of Blood, several NDA applications are reviewed each year, mostly involving solutions used for the collection of blood, such as anticoagulants and red cell nutritive solutions. Interestingly, a blood bag that does not have a solution inside is regulated as a device. If the bag has a solution, then it is a drug-device combination product, but is regulated as a drug. SLIDE 4 OBRR reviews both Class Two and Class Three devices. Class Three devices in OBRR include diagnostic tests for HIV regulated as pre-market approvals, called PMAs. -
Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods
Guidance for Industry Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods Additional copies of this guidance document are available from: Office of Communication, Training and Manufacturers Assistance (HFM-40) 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 1-800-835-4709 or 301-827-1800 (Internet) http://www.fda.gov/cber/guidelines.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) January 2001 Technical Correction February 2001 TABLE OF CONTENTS Note: Page numbering may vary for documents distributed electronically. I. INTRODUCTION ............................................................................................................. 1 II. BACKGROUND................................................................................................................ 1 III. CHANGES FROM THE DRAFT GUIDANCE .............................................................. 2 IV. RECOMMENDED DONOR SELECTION CRITERIA FOR THE AUTOMATED RED BLOOD CELL COLLECTION PROTOCOLS ..................................................... 3 V. RECOMMENDED RED BLOOD CELL PRODUCT QUALITY CONTROL............ 5 VI. REGISTRATION AND LICENSING PROCEDURES FOR THE MANUFACTURE OF RED BLOOD CELLS COLLECTED BY AUTOMATED METHODS.................. 7 VII. ADDITIONAL REQUIREMENTS.................................................................................. 9 i GUIDANCE FOR INDUSTRY Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods This -
Principles of Blood Separation and Apheresis Instrumentation
Principles of Blood Separation and Apheresis Instrumentation Dobri Kiprov, M.D., H.P. Chief, Division of Immunotherapy, California Pacific Medical Center, San Francisco, CA Medical Director, Apheresis Care Group Apheresis History Apheresis History Apheresis History Apheresis From the Greek - “to take away” Blood separation Donor apheresis Therapeutic apheresis Principles of Blood Separation Filtration Centrifugation Combined centrifugation and filtration Membrane Separation Blood is pumped through a membrane with pores allowing plasma to pass through whilst retaining blood cells. Available as a hollow fiber membrane (older devices used parallel-plate membranes) Pore diameter for plasma separation: 0.2 to 0.6μm. A number of parameters need to be closely controlled Detail of Membrane Separation Courtesy of CaridianBCT Membrane Blood Separation Trans Membrane Pressure (TMP) Too High = Hemolysis TMP Too Low = No Separation Optimal TMP = Good Separation Membrane Apheresis in the US - PrismaFlex (Gambro – Baxter) - NxStage - BBraun Filtration vs. Centrifugation Apheresis Filtration Centrifugation Minimal availability The standard in the in the USA USA • Poor industry support • Very good industry support Limited to plasma Multiple procedures (cytapheresis) exchange • Opportunity to provide • Low efficiency cellular therapies Centrifugation vs. Filtration Apheresis Centrifugation Apheresis Filtration Apheresis Blood Flow 10 – 100 ml/min 150 ml/min Efficiency of Plasma 60 – 65% 30% Removal Apheresis in Clinical Practice and Blood Banking Sickle Cell Disease Falciparum Malaria Thrombocytosis RBC WBC PLT Plasma Leukemias TTP-HUS Cell Therapies Guillain Barre Syndrome Myasthenia Gravis CIDP Autoimmune Renal Disease Hyperviscosity Syndromes Centrifugal Separation Based on the different specific gravity of the blood components. In some instruments, also based on the cellular size (Elutriation). -
Crossmatching and Issuing Blood Components; Indications and Effects
CrossmatchingCrossmatching andand IssuingIssuing BloodBlood Components;Components; IndicationsIndications andand Effects.Effects. Alison Muir Blood Transfusion, Blood Sciences, Newcastle Trust TopicsTopics CoveredCovered • Taking the blood sample • ABO Group • Antibody Screening • Compatibility testing • Red cells • Platelets • Fresh Frozen Plasma (FFP) • Cryoprecipitate • Other Products TakingTaking thethe BloodBlood SpecimenSpecimen Positively identify the patient Ask the patient to state their name and date of birth Inpatients - Look at the wristband for the Hospital Number and to confirm the name and date of birth are correct Outpatients – Take the hospital number from the notes or other documentation having confirmed the name and d.o.b. Take the blood specimen Label the tube AT THE BEDSIDE. the label must be hand-written The specimen bottle should be labelled with: First Name Surname Hospital number Date of Birth Ensure the Declaration is signed on the request form Taking blood from the wrong patient can lead to a fatal transfusion reaction RequestRequest FormForm Transfusion Sample Timings? Patients who have recently been transfused may form red cell antibodies. A new sample is required at the following times before any transfusion when: Patient Transfused or Sample required within Pregnant within the 72 hours before preceding 3 months: transfusion Uncertain or information Sample required within unavailable of transfusion or 72 hours before pregnancy: transfusion Patient NOT transfused or Sample valid for 3 pregnant within the months preceding 3 months: ABOABO GroupGroup TestingTesting •Single most important serological test performed on pre transfusion samples. Guidelines for pre –transfusion compatibility procedures •Sensitivity and security of testing systems must not be compromised. AntibodyAntibody ScreeningScreening • Antibody screening - the most reliable and sensitive method for the detection of red cell antibodies. -
Polymers for Blood Replacement Volume for 6 H, Is 90% Lost in 24 H and Is Said to Lack the Immunological Reactions of from Paul Calvert Dextran
108 Nature Vol. 280 12 July 1979 example, the J/tp at 3.1 GeV and the jet structure survives the final 'colour beneficial in shock cases. High molecular upsilon at 9.4 GeV. In these bound states washing' that creates only colourless weight dextran has anticoagulant activity the heavy quark-antiquark pair can decay hadrons out of the quark and the and it can be used for this purpose after hadronically only by annihilating into antiquark. As each of the gluons from surgery. Low molecular weight dextran is three gluons in much the same way that upsilon decay will on average carry an antigenic but there is no evidence for this positronium disintegrates into three energy of nearly 3 GeV, gluon jets can be with clinically-used dextran, although photons. The gluons of course have to expected there. The three gluons should allergic reactions occasionally occur. evolve into colourless hadrons later. The emerge symmetrically with 120° angles Various dextrans in the molecular weight glueball may lurk among such hadrons. between one another, and there is some range of 40,000-110,000 are used One interesting decay mode is when J/tp preliminary evidence for such events from depending on the balance of effect goes into an energetic photon plus hadrons. PLUTO (CERN Courier 19, 108; 1979). desired. Here the heavy quark-antiquark pair in the Another interesting possible configuration The Chinese work is from the Institute of J/tp annihilate into two gluons and a is one in which an energetic gluon dashes Organic Chemistry in Shanghai, one of the photon. -
The ABC's of Blood Components
The ABC’s of Blood Components Terry Downs, MT(ASCP)SBB Administrative Manager University of Michigan Hospitals Blood Bank and Transfusion Service Objectives Describe three additives used in blood components. List the indications for five blood components. Review whole blood donations versus apheresis collections. Whole Blood Donation Collection of one 450-500 mL of whole blood into a bag Bag then processed into components Additive solutions may be added Takes about 10 minutes to collect 500 mL Apheresis Collection of Blood Whole blood is separated into components during collection Desired component if removed Remaining components are returned to donor Centrifugal technique primarily used in US Allows for “double-red” or multiple plasma Apheresis platelets Granulocytes Collection and Storage Systems Different configurations based on intended processing method Manual processing Automated processing Platelet processing method Approved anticoagulants ACD-A ACD-B CPD CP2D CPDA-1 Contents of Anticoagulant-Preservative Solutions ACD-A CPD CP2D CPDA-1 Trisodium Citrate 22.0 g/L 26.3 g/L 26.3 g/L 26.3 g/L Citric Acid 8.0 g/L 3.27 g/L 3.27 g/L 3.27 g/L Monobasic Sodium Phosphate 0 2.22 g/L 2.22 g/L 2.22 g/L Dextrose 24.5 g/L 25.5 g/L 51.1 g/L 31.9 g/L Adenine 0 0 0 0.275 g/L Shelf Life (days) 21 21 21 35 ACD-A: Anticoagulant citrate-dextrose A CPD: Citrate-phosphate-dextrose CP2D: Citrate-phosphate-dextrose-dextrose CPDA-1: Citrate-phosphate-dextrose-adenine Additive Solutions Extend the shelf life to 42 days. -
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. -
Circular of Information for the Use of Human Blood and Blood Components
CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD Y AND BLOOD COMPONENTS This Circular was prepared jointly by AABB, the AmericanP Red Cross, America’s Blood Centers, and the Armed Ser- vices Blood Program. The Food and Drug Administration recognizes this Circular of Information as an acceptable extension of container labels. CO OT N O Federal Law prohibits dispensing the blood and blood compo- nents describedD in this circular without a prescription. THIS DOCUMENT IS POSTED AT THE REQUEST OF FDA TO PROVIDE A PUBLIC RECORD OF THE CONTENT IN THE OCTOBER 2017 CIRCULAR OF INFORMATION. THIS DOCUMENT IS INTENDED AS A REFERENCE AND PROVIDES: Y • GENERAL INFORMATION ON WHOLE BLOOD AND BLOOD COMPONENTS • INSTRUCTIONS FOR USE • SIDE EFFECTS AND HAZARDS P THIS DOCUMENT DOES NOT SERVE AS AN EXTENSION OF LABELING REQUIRED BY FDA REGUALTIONS AT 21 CFR 606.122. REFER TO THE CIRCULAR OF INFORMATIONO WEB- PAGE AND THE DECEMBER 2O17 FDA GUIDANCE FOR IMPORTANT INFORMATION ON THE CIRCULAR. C T O N O D Table of Contents Notice to All Users . 1 General Information for Whole Blood and All Blood Components . 1 Donors . 1 Y Testing of Donor Blood . 2 Blood and Component Labeling . 3 Instructions for Use . 4 Side Effects and Hazards for Whole Blood and P All Blood Components . 5 Immunologic Complications, Immediate. 5 Immunologic Complications, Delayed. 7 Nonimmunologic Complications . 8 Fatal Transfusion Reactions. O. 11 Red Blood Cell Components . 11 Overview . 11 Components Available . 19 Plasma Components . 23 Overview . 23 Fresh Frozen Plasma . .C . 23 Plasma Frozen Within 24 Hours After Phlebotomy . 28 Components Available . -
Blood Transfusion
BLOOD TRANSFUSION PETER HUDSON CLINICAL SPECIALIST What Are The Risks Associated With Blood Transfusion? • Infection transmission • Hepatitis B • Hepatitis C • HIV • Syphilis • vCJD ? • Transfusion of the wrong blood!!! Sampling Procedure • Step 1: Ask the patient to tell you their: • Full name and date of birth • Check this information against the patient s ID wristband • Get a second independent check when the patient is unconscious / compromised Sampling Procedure • Step 2: Check the patient s ID wristband against documentation e.g. case notes or transfusion request form: • First name • Surname • Date of birth • Hospital number Sampling Procedure • Only bleed one patient at a time • Do NOT use pre-labelled tubes • For transfusion samples hand write the sample tube BEFORE leaving the patients side! • NB: Avoid taking samples from a IV drip arm. • If no alternative stop infusion and wait 15 minutes before taking samples Blood Request Card Mandatory Fields Please Note: • All patients’ requiring blood products will require two group and screen samples to be taken at separate times in order to verify the patient’s correct blood type. Unless there is an existing historical blood group record when an in date second sample will be required. • Or contact blood bank Tel 3746/3747 for advice WHAT DO YOU KNOW ABOUT BLOOD TRANSFUSION? WHAT IS THE AVERAGE VOLUME OF A BAG OF PACKED RED CELLS • 280 MLS • 350 MLS • 450 MLS AVERAGE VOLUME IS 280Mls Approx 450mls is collected from donors Blood is then fractionated into plasma For FFP/cryoprecipitate,