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Blood transfusion
- 1. Blood Transfusion - Safety, optimisation & new advances Dr Shubha Allard Consultant Haematologist Barts Health NHS Trust and NHS Blood and Transplant
- 2. NHS Blood and Transplant • NHS Blood and Transplant (NHSBT) manages the national voluntary donation system for blood, tissues, organs and stem cells • Supplies around 2 million units of blood a year
- 3. Blood safety/ Transfusion safety SAFE TRANSFUSION PROCESS SAFE BLOOD COMPONENT
- 4. Blood Transfusion -Guidance and Regulations • WHO recommendations • safe and adequate blood supply • also clinical transfusion process – Appropriate use of blood – Collection samples, patient ID – compatibility testing – Administration of blood – Adverse event reporting – Hospital transfusion committee • ‘Better Blood Transfusion’ • EU Optimal Blood Use manual • (www.optimalblooduse.eu) • Council of Europe • 47 member countries
- 5. European Union Blood Directives • Setting standards of quality and safety for collection, testing, processing, storage and distribution of human blood and blood components • Blood Safety and Quality Regulations 2005 – Transposed into UK law • Regulations affect the blood services (called blood establishments) and hospital transfusion laboratories (hospital blood banks) • Competent Authority – Medicines and Healthcare products Regulatory Agency (MHRA)
- 6. Blood safety and Quality Regulations impact on hospitals in the UK • Quality management system • Stringent requirements storage/distribution blood -‘cold chain’ • standard operating procedures (SOPs) • Corrective and preventative action (CAPA) • Validation & change control – Traceability – Training and competency assessment – Haemovigilance • annual statement of compliance to MHRA • ~60 hospitals inspected per year – ‘Cease & desist’ – Critical non -compliances
- 7. Safety of the Blood Supply • Voluntary and non-remunerated donor • Donor Health Questionnaire • Council of Europe - Mandatory screening tests – Hep B, Hep C, HIV 1 & 2 – Additional testing – Syphilis, HTLV – Selective screening – Malaria, CMV
- 8. Infective risks - UK Infection Testing started Approximate risk of infection per unit of blood in UK Hepatitis B 1975 1 in 1.06 million HIV 1985 1 in 6 million Hepatitis C (Anti HCV and NAT testing) 1991 &1998 1 in 72 million Health Protection Agency
- 10. Management chronic viral hepatitis in thalassemia: recommendations of an international panel Marco et al Blood 2010 116 2875 Hep C antibody in thalassemia patients Ref no. Anti- HCV+ % 13 2006 Iran 732 19.3 14 2006 Turkey 399 4.4 15 2003 Thailand 104 21.2 16 2002 Lebanon 395 14 17 2001 India 104 21 18 Malaysia 85 22.4 21 2006 Iraq 559 67.3 22 Pakistan 35 60 23 Italy 1481 85.2 24 Bahrain 242 20.5 25 Brazil 32 46.8 26 Hong Kong 99 34 27 UK 73 23.3 Wonke B et al Clin Pathol 1990;43:638 23.3% of 73 patients positive Thompson et al 2011 Brit Journal of Haematol, 153, 121–128 Thalassemia Clinical Research Network Investigators: 169 of 697 Hep C Ab pos – 24% Cunningham et al 2004 Blood 104, 34 5% patients aged<16yrs 23% aged 16-24yrs; 70% aged 25yrs or older 1998
- 11. West Nile Virus (WNV) • Flavivirus • Most cases asymptomatic • very mild short term symptoms (20% infections) • 1% encephalitis/meningitis; can be fatal • First identified 1937 W Nile area Uganda • widely distributed Africa, West Asia, Europe & Australia; US since 1999 transmission may occur as a result of blood donation
- 12. WNV – blood donation • EU Directive - deferral for 28 days - No provision for WNV Nucleic acid testing (NAT) in place of deferral • Since 2005 UK blood services have deferred travellers – Concerns re impact on blood supply – planning 2012 Olympic s – MHRA accepted WNV NAT testing rather than donor deferral – May- Aug 2012 NHSBT has tested ~13,000 donations - so far all negative • West Nile Virus and Blood Safety Introduction to a Preparedness Plan in Europe – EU satellite meeting Working Group on Blood Safety; Jan 2011 – Surveillance, Risk assessment, Deferral criteria, NAT testing, Impact on blood supply
- 13. Variant CJD • First noted in 1996 • Distinct from sporadic CJD • Median age at presentation 26 years • Neuropsychiatric symptoms, ataxia, dementia. • Progression over 6 -40 months same strain of prion disease as Bovine Spongioform Encephalopathy (BSE) • 173 cases in UK • 4 transfusion related cases • I case in Haemophilia patient National Creutzfeldt-Jakob Disease Survellance Unit (NCJDSU) www.cjd.ed.ac.uk
- 14. Red Cells Whole Blood Platelets (also apheresis) Fresh Frozen Plasma Plasma Cryoprecipitate Paediatric FFP Paediatric Cryo Fractionation Factor concentrates egFVIII, FIXs SD plasma Immunoglobulin Albumin, Anti D (Universal leucodepletion (Non UK Plasma) in UK since 1998) Impact of nVJD on processing Blood Components UK
- 15. Blood processing – red cells • Most of the plasma is removed • Optimal Additive Solution added - SAGM in UK • Red Book Specifications • Vol = 280+ 60ml • WBC < 5 x 106 /unit • Hct 0.5 - 0.7 • 35 day shelf life • For haemoglobinopathy • Top up <14 days • exchange (SCD) <7 days • (washed red cells)
- 16. Serious Hazards of Transfusion (SHOT) • UK-wide, established1996 confidential reporting • evidence base to support – blood safety policy decisions – clinical guidelines & education – improvements in transfusion practice
- 17. Trend in total reports and total deaths definitely due to transfusionTrend in total reports and total deaths definitely due to transfusion
- 19. Special requirements Haemoglobinopathy • TIF Guidelines, UK Standards thalassaemia, Sickle Cell Disease • British Committee Standards Haematology (www.bcsh.org) • Red cells matched for Rh (D, C, c, E, e) and K antigens • Antigen negative for current or historical red cell antibodies that are clinically significant • patient’s red cells phenotyped prior to transfusion or molecular genotyping if transfused – C, c, E, e, K, k, Jka, Jkb, Fya, Fyb, MNS
- 20. Special requirements Haemoglobinopathy • SHOT UK 2011 lessons - avoidable events • Alloimmunisation SCD 20–35% or higher • Risk haemolytic transfusion reactions • Multiple & complex antibodies can result in significant delays in sourcing blood • Autoantibodies • Thompson et al 2011 Brit J Haem 153, 121 – Red cell alloimmunization diverse popn of transfused patients with thalassaemia • 697 patients 16.5% allo and 5% auto abs Anti-E 22 (19%) Anti-K 21 (18%) Anti-C 11 (9%) Anti-Kidd 9 (7%) Anti-HLA 8 (6%) Anti-c 7 (6%) Anti-e 6 (5%) Anti-Kpa 6 (5%) Anti-Lewis 4 (3%) Anti-D 4 (3%) Anti-S 3 (2%) Anti-V 2 (1%) Anti-Duffy 2 (1%) Anti-M 2 (1%) Other* 9 Thompson et al 2011 Brit J Haematol 153, 121
- 21. • SP-ICE: Anti body Database – Sharing information • Increase in blood donations from ethnically diverse groups • Rare blood units frozen • International Rare Donor Panel, IBGRL, Bristol, UK -worldwide collaboration 5000 donors, 28 countries frequency (%Blood group CaucasAfricanian African Rh D 85 92 C 70 30 E 30 19 Kell K 9 2 Kidd Jka 77 92 Jkb 74 49 Duffy Fya 66 10 Fyb 83 23 Blood Group AfricanCaucasia n Frequency % NHSBT – a focus on improving care for haemoglobinopathy patients
- 22. Molecular techniques - Extended red cell matching • Automated, high throughput testing platforms – now available for molecular testing • ?scope for extended donor testing and greater red cell antigen matching with recipient • NHS Blood and Transplant - Evaluation of chip based and Luminex based genotyping platforms – Panel of 1,000 DNA samples from donors with known phenotype – Inter platform discrepancy very low (0.04%) across >20,000 blood groupings – Pilot H&I and RCI labs implementation patient testing
- 23. Red cells from stem cells Harvey G. Klein. Brewing blood Blood 2011 118, 5069 Standardised well characterised, readily available red cells? Culture systems to generate erythroid cells in laboratory from •Somatic stem cells •Embryonic stem cells •Induced pluripotent stem cells Ex vivo production of human red cells, the Holy Grail of blood transfusion. illustration by Debra T. Dartez.
- 24. Blood safety, optimisation and new advances • Transfusion transmitted infections – Reduced rates, never zero risk, emerging infections • Adherence to guidelines – avoidable alloimunisation • Haemovigilance – Essential for improving transfusion safety – Highlights areas for action • New advances – e.g. IT, molecular techniques, pathogen activation
- 25. Our views have increased the mark of the 10,000 Thank you viewers Looking forward to franchise, collaboration, partners.
- 26. This platform has been started by Parveen Kumar Chadha with the vision that nobody should suffer the way he has suffered because of lack and improper healthcare facilities in India. We need lots of funds manpower etc. to make this vision a reality please contact us. Join us as a member for a noble cause.
- 27. Contact us:- 011-25464531, 9818569476 E-mail:- nursingnursing@yahoo.in
- 28. Our views have increased the mark of the 10,000 Thank you viewers Looking forward to franchise, collaboration, partners.
- 29. This platform has been started by Parveen Kumar Chadha with the vision that nobody should suffer the way he has suffered because of lack and improper healthcare facilities in India. We need lots of funds manpower etc. to make this vision a reality please contact us. Join us as a member for a noble cause.
- 30. Contact us:- 011-25464531, 9818569476 E-mail:- nursingnursing@yahoo.in
Editor's Notes
- Red cell alloimmunization in a diverse popn of transfused patients with thalassaemia
- Genus: Flavivirus Japanese Encephalitis Antigenic Complex complex includes: Japanese encephalitis, Kunjin, Murray Valley encephalitis, St. Louis encephalitis, WNV Flaviviruses share a common size (40-60nm), symmetry (enveloped, icosahedral nucleocapsid), nucleic acid (positive-sense, single stranded RNA approximately 10,000-11,000 bases), and appearance under the electron microscope WNV strains classified into a number of lineages currently at least 7 putative genetic lineages lineages may subdivide into subclades/cluster Lineage 1: most widespread, global distribution Lineage 2: sub-Saharan Africa, ? Central Europe Lineage 3 (Rabensburg): Central Europe Lineage 4: Central Europe Lineage 5: India Lineage 6: reclassification of Sarawak Kunjin Lineage 7: African Koutango virus Lineage 8: (proposed) strain isolated in Spain in 2006 Arthropod-borne (arbovirus) Primarily circulates in an enzootic cycle between birds (hosts) and mosquitoes (vectors) Culex species are the normal vectors Culex modestus now found in in Essex/Kent around the Thames estuary Mammal (including humans) incidental hosts Incidence of infections seasonal in line with mosquito ‘season’ in temperate regions evidence of ‘all year’ season in US Most cases asymptomatic or very mild symptoms (20% infections) with complete resolution and no clinical consequences febrile illness of sudden onset, often accompanied by malaise, anorexia, nausea, vomiting, eye pain, headache, myalgia, rash, and lymphadenopathy; these symptoms generally last 3 to 6 days. Approximately 1% of cases experience serious neurologic symptoms (neuroinvasive disease) associated with advanced age (major factor) immunosuppression Findings among hospitalised individuals include: encephalitis–meningoencephalitis, more frequently than meningitis severe muscle weakness flaccid paralysis fever changes in mental status First identified in 1937 in West Nile area of Uganda Until 1999, the virus was found only in the Eastern Hemisphere, with wide distribution in Africa, Asia, the Middle East, and Europe. infrequent human outbreaks, mainly assoc. with mild febrile illnesses outbreak in Israeli nursing homes in 1957 associated with severe neurologic disease and death Since the mid-1990s, the frequency and apparent clinical severity of West Nile virus outbreaks and sporadic cases have increased outbreaks in Romania (1996), Russia (1999), Israel (2000) involving hundreds of individuals with severe neurologic disease Czech Republic (1997), France (2000, 2003, 2004, 2006), Italy (1998, 2008, 2009), Hungary (2000-2009), Romania (1997-2001, 2003-2009), Spain (2004) and Portugal (2004).
- Rapid infection, incubation period 2-14 days Resolves in most uncomplicated cases in 2-6 days Most cases fully cleared within 1 month of exposure Relatively low level, transient, viraemia appearing within 4-5 days and lasting no more than 2 weeks IgM usually appears within 8 days of infection IgG usually appears within a week of IgM Both molecular and serological targets viral RNA viral antigen specific antibody, IgM/IgG Difference between screening and diagnostics evidence of infection, current or past evidence of infectivity
- BSE occurred as an epidemic in UK cattle following its identification in 1985, with over 180,000 clinical cases of BSE identified to date
- Above summarises impact of some of the vCJD risk reduction measures in processing of blood and components in the UKLeucodepletion 1998 UK plasma not used for fractionation Non UK plasma for children born after 1996 Exclude donors transfused after 1980 Reduce plasma in components Increase platelets from apheresis (from ~40% to 80%) Consideration prion filters Appropriate use Better Blood Transfusion
- UK-wide, independent, professionally led hemovigilance system focused on learning from adverse events established1996 confidential reporting evidence base to support blood safety policy decisions, clinical guidelines, clinician education, and improvements in transfusion practice
- Undertaking further extended red cell typing of patients aids further serological testing in the event of antibody formation and appropriate selection of antigen negative blood. failure to include the correct diagnosis on the request form patients present to a different hospital with no access to records patients transferred without access to important historical records Alloimunisation risk lower in thalassaemia lower but variation Lowest rates (around 4%) if regular transfusion from very young age higher rates if later onset of transfusion or if absence of policies for RBC phenotype matching
- Planning – oversight of difficult patients, call in donors, communication between teams, around 600 frozen units at a given time Only bleed donors 4 times a year so need more
- DNA based technologies have been successfully applied to blood group genotyping for over twenty years. The genes encoding 29 of the 30 known blood group systems have been sequenced with only the P system resisting resolution. Initially red cell genotyping methods were technically complex and time consuming and could only be applied in specialist laboratories such as IBGRL. During the last decade many of the discrepancies detected between the serologically derived phenotype and DNA determined genotype have been investigated and resolved. The development of automated, high throughput testing platforms has now enabled molecular testing for all the major blood group antigens in a single assay without the need for complex testing protocols, high level technical skills or skilled interpretation. Due to the complexity of the alleles determining the ABO and RhD groups haemagglutination remains the most reliable and robust method for routine ABO and RhD typing. The majority of the other blood group systems are the result of single nucleotide substitutions making design of molecular typing tests relatively straightforward
- Most culture systems 4 to 5 step process to effect lineage specific commitment, expansion, maturation and enucleation assoc withcomplex mixtures growth factors, coculture with feeder cells often of murine origin. Paris group achieved production under GMP conditions, homogenous population with properties (morphology, biochemistry, antigenic and functional appearance of RBCs) store well in refrigerated temps and circulate with half survival time comparable with native RBCs First transfusion in human Challenges of scale remain a formidable hurdle