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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) - PowerPoint PPT Presentation
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Clinical Working GroupClinical Working Group(S(P)EAR committee)(S(P)EAR committee)
ReportReport
Sydney 2012Sydney 2012
Chair: Bronwen ShawVice-chair: Jeff Szer
S(P)EAR committeeS(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)
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
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)
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)
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
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)
SPEARSPEAR 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• UD withdrawn after conditioning started - re-search initiated (NA/definite)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’)