From Buffy Coat Platelets to Single Donor Platelets

1
From Buffy Coat Platelets to Single Donor
Platelets A Feasibility Study

• Dr. Sybesma, Sanquin Bloodbank Southeast,
• s-Hertogenbosch, Netherlands
• St. Petersburg - June 9th - 2004

2
Introduction

• ? Pilot-study
• ? Donors, Methods
• ? Results
• ? Conclusions
• ? Discussion

3
Improvement of transfusion safety by reduction
of donor exposure

• Variant Creutzfeldt-Jakob disease (Houston et
  al. 2000)
• Septic platelet transfusion reactions (Ness et
  al. 2001)
• Residual risk of viral infection (Soldan et al.
  2003, Jackson et al. 2003)
• HLA - (Slichter 1998) and HPA - refractoriness
• TRALI
• Unknown agents

4
Donors and methods

• ? Technical
• donors selection precount gt 250, 70 kg
• Trima Accel, 100 procedures
• procedure time 70
• QC, splitting gt 500
• ? Economical
• 434 Euro pooled and single donor
• ? Logistical
• autosufficient 2500 PLT per year
• nov 2002

5
De machine TRIMA ACCEL

• COBE Spectra dubbele naald techniek weinig
  comfortabel. Continue 2 stapsscheiding WBC gt
  108 daarom grote LRS-kamer snel, goede oogst
• TRIMA 4.0 enkele naald. Continue 2
  stapsscheiding WBC lt 106 kleine LRS-kamer
  snel, hoge oogst,
• TRIMA 5.0 (Accel) 1-staps scheiding nog meer
  oogst per tijdseenheid (plaatjes collectie
  efficientie), LRS-kamer van de Spectra WBC lt
  106, minder extra corpereel volume (lt 200 ml),
  minder citraat naar donor, automatische
  aanpassing van draw en return minder alarm.
• Na einde bewaartijd (5 dagen en 7 dagen) in vitro
  voldoende plaatjesfunctie

6
TRIMA Accel
7
Donorselection
8
Number procedures per procedure time
9
Donor reactions

• Form
• 289 procedures
• Citrate reactions
• Mild 37,
• Moderate 1,
• Severe 0
• Collaps 0
• Haematoma 5
• Hyperventilation 0

10
Predicted Procedures, DPP and SDP for predicted
yield (n100)
11
Evolution - Real/Target Yield
12
Evolution of split-rate (gt500x10e9)
13
Chronological trending of residual WBC levels
14
Logistical feasibility

• ? TRIMA 6 procedures per day
• ? 50 weeks
• ? 190 donors
• ? 8 donations per year
• ? 2600 SDP per year
• ? 18 drop-out by out-dating
• Lazarus et al. 2001

15
Donor satisfaction
16
Economical feasibility

• Pooled PLT 434
• Cost / procedure 62
• manufacturing / quality controle
• Cost / product 62
• Bact Alert / distribution 27
• Variable cost / product 89
• nov 2002

• Apheresis PLT 434
• Cost / procedure 269
• donorrelated / manufacturing / screening and
  quality control / device
• 1.76 product / procedure
• Cost / product 152
• Bact Alert / distribution 27
• Variable cost / product 179

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Economical feasibility

• Cost price for SDP are less than revenues
• High split rates are beneficial for economical
  feasibility
• Revenues for SDP are higher than for BCP
• Cost of SDP are higher than for BCP
• Distribution of secondary costs over different
  components influence the cost of BCP

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Conclusions

• ? Conversion is feasible economically,
  technically and logistically.
• ? Adequate donor selection high collection
  performence assure high split-rates in relatively
  short procedure time.
• ? further research is needed on
• how to keep donormotivation at high level
• donor recruitment and donor selection
• possibilities to reduce drop-out by outdating
• Cost / Qualys for pooled and apheresis PLT
  should be analyzed

19
Discussie

• Voor
• ? zorginnovatie
• ? gezondheidswinst
• ? Spin-off
• vCJD / onbekende agens / TRALI / anti-HLA
  preventie / windowdonaties

• Tegen
• ? inkomsten 487.500

20
Hoe verder

• ? voortgang invoering aferesetrombocyten
• ? Werkgroep voorbereiding implementatie zuidoost
• plan van aanpak feb 2004
• start september 2004
• ?

21
Met dank aan

• Projectgroepleden
• Speciaal Bob en Astrid

22
Referenties

• MAR Inzake vCJD en mogelijke maatregelen mbt
  bloedtransfusie / Houston art.
• art. P. Brown. BSE and transmission through
  blood The Lancet Vol 356 sept 16, 2000
• art. F. Houston et al. Transmission of BSE by
  blood transfusion in sheep. The Lancet vol 356
  sept 16, 2000.
• art. W.G. van Aken, A. Brand en C.L. van der
  Poel Leukodepletie van bloedproducten een
  maatregel ten behoeve van kwaliteit en
  veiligheid. NTVG 2000 27 mei144(22)
• art. H.L. Zaaijer Boviene spongiforme
  encephalopathie en de veiligheid van voedsel
  NTVG 2000 27 mei144 (22)
• art. H.L. Zaaijer Interpretatie van de toename
  van boviene spongiforme encephalopathie buiten
  Groot-Brittannie. NTVG 2002 20 april146(16)
• art. E.A. Groes et al. Ziekte van
  Creutzfeldt-Jakob diagnostiek, incidentie,
  preventie en behandeling. NTVG 2002 20 april146
  (16)
• art. R. Kersseboom et al. Het risico van de
  variant Creutzfeldt-Jakob in Nederland en het
  effect van preventieve maatregelen. NTVG 2002 20
  april146 (16)
• art W.G. van Aken Variant van de ziekte van
  Creutzfeldt-Jkob en bloedtransfuzierapport van
  de gezondheidsraad NTVG 2001 28 juli145 (30)