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

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Presentation on theme: "Clinical Working Group (S(P)EAR committee) Report Sydney 2012 Chair: Bronwen Shaw Vice-chair: Jeff Szer."— Presentation transcript:

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depends on whether transplant is cancelled/delayed e.g. CBU arrived thawed – re-search initiated (definite) UD withdrawn after conditioning started - re-search initiated (NA/definite) Cracked CBU – replacement ordered and infused (excluded) Insufficient CD34 cells collected, PGF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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