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• UD withdrawn after conditioning started - re-search initiated (NA/definite)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’)