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Clinical Working Group (S(P)EAR committee) Report Sydney 2012

Clinical Working Group (S(P)EAR committee) Report Sydney 2012. Chair: Bronwen Shaw Vice-chair: Jeff Szer. S(P)EAR committee. 62 S(P)EAR reported since the last meeting 35 S(P)EAR reported in 2012 until March 27 S(P)EAR reported in 2011 (Nov and Dec) 29 SPEAR (product related)

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Clinical Working Group (S(P)EAR committee) Report Sydney 2012

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  1. Clinical Working Group (S(P)EAR committee) Report Sydney 2012 Chair: Bronwen Shaw Vice-chair: Jeff Szer

  2. S(P)EAR committee • 62 S(P)EAR reported since the last meeting • 35 S(P)EAR reported in 2012 until March • 27 S(P)EAR reported in 2011 (Nov and Dec) • 29 SPEAR (product related) • 33 SEAR (donor related)

  3. SEAR Early (initiation of GCSF until 30 days post) • 16 SEAR In 11, committee agrees imputability • 6 definite e.g. haematoma, low platelets • 1 probable – tachycardia during injections • 4 possible e.g. renal infarction D14 post, zoster

  4. SEAR In 5, committee disagrees imputability • Calf spasm D3 of GCSF (definite/probable) • Viral myocarditis (possible/unlikely) • Collapse and low BP in hospital after BM – auto and allo unit infused (NA/definite) • CNS haemorrhage 5 weeks after donation (NA/unlikely or possible) • Anaphylaxis during apheresis (excluded/possible)

  5. SEAR Late • 17 SEAR • Tend to be unlikely/excluded • Review committee almost always in agreement • Examples include: • Late malignancy • GI or vascular problem • Late onset joint pain (7 months): committee divided (possible/unlikely)

  6. SPEAR • 29 SPEAR • In many cases imputability is disagreed between reporter and review committee • The imputability should be assigned to ‘patient harm’ not to quality of the product/transport etc

  7. SPEAR SPEAR due to patient event (2) • TRALI (2) tends to be ‘possible’ (or NA) SPEAR due to product quality/transport (27) • Used product (16): • E.g. viability, X-ray, faulty bags • Engraftment is key determinant of imputability (i.e. usually ‘excluded/unlikely’ NOT definite)

  8. SPEAR SPEAR due to product quality/transport (27) • Did not use product (11): • Imputability depends on whether transplant is cancelled/delayed e.g. • CBU arrived thawed – re-search initiated (definite) • UD withdrawn after conditioning started - re-search initiated (NA/definite) • Cracked CBU – replacement ordered and infused (excluded) • Insufficient CD34 cells collected, PGF (definite) • Only 1 day of harvest transported (‘open’)

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