Safer, Cheaper and Just as Good: Safer, Cheaper and Just as Good: Making Sterile, 7-Day Platelets a Reality Making Sterile, 7-Day Platelets a Reality James P. AuBuchon, MD James P. AuBuchon, MD E. Elizabeth French Professor and Chair of Pathology E. Elizabeth French Professor and Chair of Pathology Dartmouth-Hitchcock Medical Center Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire Lebanon, New Hampshire
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Safer, Cheaper and Just as Good: Making Sterile, 7-Day Platelets a Reality James P. AuBuchon, MD E. Elizabeth French Professor and Chair of Pathology Dartmouth-Hitchcock.
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Safer, Cheaper and Just as Good:Safer, Cheaper and Just as Good:Making Sterile, 7-Day Platelets a RealityMaking Sterile, 7-Day Platelets a Reality
James P. AuBuchon, MDJames P. AuBuchon, MDE. Elizabeth French Professor and Chair of PathologyE. Elizabeth French Professor and Chair of Pathology
Dartmouth-Hitchcock Medical CenterDartmouth-Hitchcock Medical CenterLebanon, New HampshireLebanon, New Hampshire
Safer, Cheaper and Just as Good:Safer, Cheaper and Just as Good:Making Sterile, 7-Day Platelets a RealityMaking Sterile, 7-Day Platelets a Reality
1: Why we are interested in this1: Why we are interested in this2: Whether it is feasible2: Whether it is feasible
Comparison of Residual RisksComparison of Residual Risks
200 mL red cells200 mL red cells30 mL plasma30 mL plasma110 mL additive solution110 mL additive solution
4 x 104 x 101111 platelets platelets300 mL plasma300 mL plasma
What Are You Transfusing?What Are You Transfusing?
Red Blood Cells
Platelets
200 mL red cells200 mL red cells30 mL plasma30 mL plasma110 mL additive solution110 mL additive solution101099 YersiniaYersinia per mL + endotoxin per mL + endotoxin
4 x 104 x 101111 platelets platelets300 mL plasma300 mL plasma101088 StaphStaph per mL per mL
What Are You Transfusing?What Are You Transfusing?
The Problem with Platelets…The Problem with Platelets…
Bacterial contamination is Bacterial contamination is - frequent- frequent- initially at very low concentration- initially at very low concentration- very difficult to detect- very difficult to detect
- in unit- in unit- in patient- in patient
Unit TransfusedUnit Transfused Risk per Million UnitsRisk per Million Units Confirmed Report ofConfirmed Report of FatalityFatalityBacterial ContaminationBacterial Contamination
Red Blood CellsRed Blood Cells 6.0 6.0 1.01.0Plateletpheresis unitsPlateletpheresis units 3232 7.17.1TOTAL, all unitsTOTAL, all units 7.4 7.4 1.11.1
Perez P Perez P et al. Transfusionet al. Transfusion 1999;39:2S. 1999;39:2S.
Unit TransfusedUnit Transfused Risk per Million UnitsRisk per Million Units Confirmed Report ofConfirmed Report of FatalityFatalityBacterial ContaminationBacterial Contamination
Red Blood CellsRed Blood Cells 6.0 6.0 1.01.0Plateletpheresis unitsPlateletpheresis units 3232 7.17.1TOTAL, all unitsTOTAL, all units 7.4 7.4 1.11.1
Perez P Perez P et al. Transfusionet al. Transfusion 1999;39:2S. 1999;39:2S.
Staph. saprophyticusStaph. saprophyticus (1)(1) P. rettgeriP. rettgeri (1)(1)
Bacillus cereusBacillus cereus (1)(1) Y. enterocoliticaY. enterocolitica (1)(1)
E. faecalisE. faecalis (1)(1)
Strep. pneumoniaeStrep. pneumoniae (1)(1)
*includes isolates from RBCs*includes isolates from RBCs Kuehnert Kuehnert et al. Transfusionet al. Transfusion 2001;41:1493-9. 2001;41:1493-9.
Leach MF Leach MF et al. Vox Sanget al. Vox Sang 1998;74(suppl 1):1180. 1998;74(suppl 1):1180.
Bacterial Growth Kinetics in PlateletsBacterial Growth Kinetics in Platelets
1.E+00
1.E+01
1.E+021.E+03
1.E+04
1.E+051.E+06
1.E+07
1.E+081.E+09
0 1 2 3 4 5
S. epi.S. aureusSalmonella
Storage time, d
Bacterial concentration/mL
Inoculation: 1 CFU/mL
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
Brecher M Brecher M et al. Transfusionet al. Transfusion 2001;41:477-82. 2001;41:477-82.
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
Time to Detection in an Automated Culturing SystemTime to Detection in an Automated Culturing System
Inoculum: 4 mLInoculum: 4 mL
New Concept: Hospital-Based Verification of SterilityNew Concept: Hospital-Based Verification of Sterility
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
BacT Alert
ENTRY INTO INVENTORY
DAY 2: CULTURE
TRANSFUSION ORDER: RELEASE UNIT
POSITIVE AUTOMATED CULTURE
Interdiction of release
New Concept: Hospital-Based Verification of SterilityNew Concept: Hospital-Based Verification of Sterility
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
BacT Alert
ENTRY INTO INVENTORY
DAY 2: CULTURE
TRANSFUSION ORDER: RELEASE UNIT
POSITIVE AUTOMATED CULTURE
Interdiction of release
Providing:Providing:Assurance of sterilityAssurance of sterilityStorage to 7 days Storage to 7 days Storage after poolingStorage after poolingReduced cost for leukoreductionReduced cost for leukoreduction
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Experience in first 2 years:Experience in first 2 years:2,569 units cultured 2,569 units cultured (5 mL into aerobic bottle, BacT/Alert automated system)(5 mL into aerobic bottle, BacT/Alert automated system)
11 not confirmed on repeat culture11 not confirmed on repeat culture5 not able to be recultured5 not able to be recultured (1: positive after transfusion)(1: positive after transfusion)
May, 1999 - April, 2001May, 1999 - April, 2001
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Recent experience:Recent experience:Split double SDP unit received Split double SDP unit received (external source)(external source)
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
Dartmouth-Hitchcock Medical CenterDartmouth-Hitchcock Medical Center American Red Cross, NorfolkAmerican Red Cross, NorfolkJames P. AuBuchon, MDJames P. AuBuchon, MD John B. Nobiletti, MDJohn B. Nobiletti, MDLouise Herschel, BS, MLT(ASCP), CCRC Louise Herschel, BS, MLT(ASCP), CCRC Deanna A. McNeil,MLT(ASCP) Deanna A. McNeil,MLT(ASCP) Jill Roger, MT(ASCP), CCRCJill Roger, MT(ASCP), CCRC Sherrie L. Sawyer, MSSherrie L. Sawyer, MS
Risks expressed per millionRisks expressed per million
$65/unit$65/unit
OUTDATEREDUCTIONS
NO NO CULTURECULTURE
CULTURECULTURE+ 7d+ 7d
Per-unit HIV risk: 1/1,000,000Per-unit HIV risk: 1/1,000,000Septic mortality: 1/140,000Septic mortality: 1/140,000
Other applications of culturing + 7d dating --Other applications of culturing + 7d dating --
Prestorage pooling of platelet concentratesPrestorage pooling of platelet concentrates- simplicity for transfusion service- simplicity for transfusion service- - preprestorage leukoreductionstorage leukoreduction- reduction in filtration cost- reduction in filtration cost- sterility assessment in highest-risk component- sterility assessment in highest-risk component- reduced outdating- reduced outdating
Therefore -Therefore -
Platelet storage for 7d Platelet storage for 7d is feasibleis feasible- Adequate maintenance of function- Adequate maintenance of function- Expected recovery and survival- Expected recovery and survival- Adequate clinical efficacy- Adequate clinical efficacy
indistinguishable from shorter storageindistinguishable from shorter storage- Bacterial culturing to reduce septic risk- Bacterial culturing to reduce septic risk- Reduction in overall risk- Reduction in overall risk- No increase in cost - No increase in cost -- therefore practical-- therefore practical
Safer, Cheaper and Just as GoodSafer, Cheaper and Just as GoodMaking Sterile, 7-Day Platelets a RealityMaking Sterile, 7-Day Platelets a Reality