Reporting Serious Adverse Reactions

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Reporting Serious Adverse Reactions

• The Haemovigilance Handbook
• Marina Cronin
• National Haemovigilance Office

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Today's presentation will

• Clarifies the reporting requirements for
  Hospitals
• Reporting of SARs, which are attributable to the
  quality and safety of the blood component, is now
  mandatory

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Serious Adverse Reaction (SAR)

• An unintended response in a donor or in a patient
  associated with the collection or transfusion of
  blood or blood components that is
•         Fatal,
•         Life-threatening,
•         Disabling,
•         Incapacitating,
• Or
• Results in, or prolongs, hospitalisation or
  morbidity

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Imputability

• . the likelihood that a serious adverse reaction
  in a recipient can be attributed to the blood or
  blood component transfused or that a serious
  adverse reaction in a donor can be attributed to
  the donation
• (Directive 2005/61/EC Article 1)
• Must determine Imputability of SAR
• (Directive 2005/61/EC Article 5)

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Evaluating SAR
Directive 2005/61/EC Annex 2 Part B
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Reporting SAR

• notify to the competent authority all relevant
  information about serious adverse reactions of
  imputability level 2 or 3, .. attributable to
  the quality and safety of blood and blood
  components
• notify the competent authority of any case of
  transmission of infectious agents by blood and
  blood components as soon as known
• (Directive 2005/61/EC Article 5)

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Rapid Alert Notification for SAR

• Suspected bacterial infection
• Viral, parasitic or other post transfusion
  infection
• TRALI

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Acute Haemolytic Transfusion Reactions

• AHTR is defined as a reaction occurring within 24
  hours of a transfusion where clinical and/or
  laboratory features of haemolysis are present
• EU categories are
• Immunological haemolysis due to ABO
  incompatibility
• Immunological haemolysis due to other
  alloantibody - Acute
• Non immunological haemolysis

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Reporting AHTR

• Reporting of cases of AHTR which are considered
  likely probably or certainly associated with
  transfusion (imputability level 2/3) is now a
  mandatory requirement.

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Investigations for AHTR

• Clerical laboratory investigations for
  haemolysis
• Out rule bacterial contamination
• Out rule underlying condition

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Febrile Non Haemolytic Transfusion Reaction
(FNHTR)

• a rise in temperature of gt1.5oC, above the
  patients (pre-transfusion) baseline value
• together with rigors or chills
• /- other symptoms
• during or within four hours following transfusion
  
• without any other cause such as haemolytic
  transfusion reaction, bacterial contamination or
  the patients primary diagnosis
• symptoms lead to increased morbidity

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Reporting FNHTR

• Symptoms of FNHTR lead to increased morbidity or
  prolonged hospitalisation for patients ?
• Isolated fever which has been fully investigated
  but has not revealed evidence of haemolysis or
  bacterial contamination ?
• Symptoms are considered due to the patients
  primary diagnosis and not due to the transfusion
  ?

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Laboratory Investigations for FNHTR

• Out rule haemolysis clerical and laboratory
  investigations
• Out rule bacterial contamination

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Acute Allergic and Anaphylactic Transfusion
Reaction (AA)

• Occurs when a patient who is pre-sensitised to an
  allergen, is re-exposed to the particular
  antigen.
• Patients with severe IgA deficiency may develop
  antibodies to IgA. Some of these patients may
  have severe anaphylaxis if exposed to IgA through
  transfusion

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Reporting AA Reactions

• Allergic type reactions ?
• Pruritus, mild rashes and urticaria ?
• AA is incorporated in the following EU category
  Anaphylaxis / hypersensitivity.

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Investigations for AA

• Frequently no cause identified
• Out rule other causes of allergic reaction
• IgA levels
• Tryptase levels prior to and within 2-3 hours of
  transfusion

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Delayed Haemolytic Transfusion Reactions (DHTR)

• Evidence of clinical or laboratory features of
  haemolysis occurring more than 24 hours and up to
  28 days following the transfusion of a blood
  component and associated with serological
  evidence of antibodies (ISBT Working Party,
  Capetown, 2006).
• EU category Immunological haemolysis due to
  other alloantibody

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Reporting DHTR

• Detection of red cell antibodies within 28 days
  with evidence of haemolysis ?
• Detection of red cell antibodies over a month
  after transfusion without evidence of clinical or
  laboratory evidence of haemolysis are termed
  delayed serological reactions ?

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Investigations for DHTR

• Investigations for haemolysis to include
• Hb,
• LDH,
• Bilirubin,
• Haptoglobin
• Serological investigations e.g. DAT, detection of
  red cell antibodies

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Transfusion Associated Circulatory Overload
(TACO)

• Characterised by the development of acute
  pulmonary oedema due to cardiac overload as a
  result of transfusion
• TACO is incorporated in the following EU
  category Other TACO

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Investigations for TACO

• Careful clinical assessment of cardiovascular
  status
• Assessment of fluid balance and response to
  diuretics
• Chest x-ray
• Pre post transfusion Brain Natriuretic
  Peptide(BNP) and/or NT- pro BNP within 2 hours
• Troponin levels may be helpful in differentiating
  TACO from acute myocardial ischemia

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Transfusion Related Acute Lung Injury

• Characterised by acute respiratory distress, with
  bilateral pulmonary oedema but no evidence of
  cardiac failure or fluid overload
• Symptoms always within 6 hrs of transfusion
• Canadian Consensus Conference suggests that TRALI
  incidents be divided into TRALI and possible
  TRALI
• 
  (Kleinman et al, 2004)

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TRALI characteristics

• Acute onset of symptoms
• Hypoxemia SpO2 lt 90 on room air or other
  evidence of hypoxemia
• Bilateral infiltrates on frontal chest X-ray

• No evidence of circulatory overload
• No pre-existing acute lung injury (ALI) before,
  during, or within six hrs of transfusion
• No alternative risk factors for Acute Lung Injury
  present

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Possible TRALI

• is characterised by the following
• ALI as described above
• No pre-existing ALI before, during, or within six
  hrs of transfusion
• Presence of alternative risk factors for Acute
  Lung Injury (see handbook)

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Investigations for TRALI (Hospital Based)

• Out rule circulatory overload
• Assess fluid balance
• Pre and post transfusion samples for BNP and/or
  NT- pro BNP levels to out rule TACO
• Frontal Chest x ray,
• HLA antibodies should be sent to the IBTS HLA
  laboratory

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Suspected Transfusion Transmitted Infection (STTI)
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Reporting Transfusion Transmitted Viral Infections

• Related to blood components - after the
  introduction of mandatory testing for that virus
  e.g. HIV 1 2 (October1985)
• Viral infections not covered by mandatory
  testing, but which are suspected to be associated
  with a blood transfusion e.g. Hep A

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Investigations for Suspected Transfusion
Transmitted Viral Infection (Patient)

• Clinical assessment of risk status of patient
• Reports of possible viral transfusion infection
  should be based on confirmed positive results
• Previous archived samples of patients are useful

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Reporting Transfusion Transmitted Parasitic
Infection

• All suspected transfusion transmitted parasitic
  infections, which have occurred since 1st
  October, 1999 e.g. malaria, toxoplasmosis.

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Investigations for Suspected Transfusion
Transmitted Parasitic Infection (Patient)

• Investigations to be undertaken are dependent on
  the type of parasite and will be decided on
  following discussions between the IBTS and the
  hospital.

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Reporting Suspected Transfusion Transmitted
Bacterial Infection

• Bacterial infection suspected to be transfusion
  related.
• In case of bacterial infection, results of
  culture of both patient and packs should be
  available.

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Investigations for Suspected Transfusion
Transmitted Bacterial Infection (Patient)

• Blood cultures of the patient
• Culture of the pack contents and segment line
• Out rule other sources of sepsis in patient e.g.
  sputum, urine, wound swab or other if clinically
  indicated

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Transfusion Associated Graft-versus-Host Disease
(TA-GvHD)

• Occurs where viable donor lymphocytes transfused
  in a blood component attack recipient tissues in
  immunosuppressed or immunodeficient patients
• EU category Graft versus host disease

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Post-Transfusion Purpura (PTP)

• Characterised by thrombocytopenia arising 5-12
  days following transfusion of blood components.
• Supported by findings of antibodies in the
  patient directed against the Human Platelet
  Antigen (HPA) system.
• PTP is an EU Notification Category

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Previously Unreported Complication of Transfusion
(PUCT)

• Occurrence of an adverse effect or reaction
  temporally related to transfusion which cannot be
  classified according to an already defined
  Adverse Transfusion Reactions and with no risk
  factor other than transfusion.
• Incorporated in the following EU category Other
  serious reaction

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Reporting PUCT

• All reactions which are new, previously
  unreported
• Cannot otherwise be categorised
• Are considered likely, probably or certainly
  related to the transfusion

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Investigations for PUCT

• Out rule other causes of reaction such as
  haemolysis, bacterial contamination or
  respiratory distress i.e. TACO or TRALI.
• Following clinical assessment other
  investigations should be considered

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Required Information on SAR for Inclusion in
Reports to NHO

• Outlined in the handbook for individual

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Clinical Outcome
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Information available at

• National Haemovigilance Office pages on IBTS
  website www.ibts.ie
• Haemovigilance Handbook Consultation Document
• NHO Revised Forms 2007 Guidance Document