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
HIVHIV
HBVHBV
HCVHCV
19961996199419941992199219901990198819881986198619841984
1:1001:100
1:10001:1000
1:10 0001:10 000
1:100 0001:100 000
1:1 000 0001:1 000 000
19981998 20002000
Transmission risk, Transmission risk, per unitper unit
Updated from: Goodnough LT Updated from: Goodnough LT e t al. NEJMe t al. NEJM 1999;341:126-7 1999;341:126-7
Comparison of Residual RisksComparison of Residual Risks
BacterialBacterialContaminationContamination
(platelets)(platelets)
SepticSepticFatalitiesFatalities(platelets)(platelets)
HIVHIV
HBVHBV
HCVHCV
19961996199419941992199219901990198819881986198619841984
1:1001:100
1:10001:1000
1:10 0001:10 000
1:100 0001:100 000
1:1 000 0001:1 000 000
19981998 20002000
Transmission risk, Transmission risk, per unitper unit
Updated from: Goodnough LT Updated from: Goodnough LT e t al. NEJMe t al. NEJM 1999;341:126-7 1999;341:126-7
Frequency of Transfusion-Related Fatalities FDA Data: 1990-1998
Frequency of Transfusion-Related Fatalities FDA Data: 1990-1998
Adverse Event Cases Hemolysis 161 (50%) Bacterial contamination 46 (10%) TRALI 29 (9%) Non-bacterial infections 23 (7%) Transfusion-associated GvHD 18 (6%)
Adverse Event Cases Hemolysis 161 (50%) Bacterial contamination 46 (10%) TRALI 29 (9%) Non-bacterial infections 23 (7%) Transfusion-associated GvHD 18 (6%)
J-H Lee, MD, CBER, FDA, 9/24/99J-H Lee, MD, CBER, FDA, 9/24/99
Frequency of Transfusion-Related Fatalities FDA Data: 1990-1998
Frequency of Transfusion-Related Fatalities FDA Data: 1990-1998
Adverse Event Cases Hemolysis 161 (50%) Bacterial contamination 46 (10%) TRALI 29 (9%) Non-bacterial infections 23 (7%) Transfusion-associated GvHD 18 (6%)
Adverse Event Cases Hemolysis 161 (50%) Bacterial contamination 46 (10%) TRALI 29 (9%) Non-bacterial infections 23 (7%) Transfusion-associated GvHD 18 (6%)
J-H Lee, MD, CBER, FDA, 9/24/99J-H Lee, MD, CBER, FDA, 9/24/99
Red Blood Cells
Platelets
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.
Bacterial Contamination Risks Bacterial Contamination Risks
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.
Bacterial Contamination Risks Bacterial Contamination Risks
1/140,000
Clinical cases of post-transfusion sepsis Clinical cases of post-transfusion sepsis 162 - 288 per year162 - 288 per year
FatalitiesFatalities 4.5 - 18 per year4.5 - 18 per year
BaCon Report, 1999 AABB Annual Meeting.BaCon Report, 1999 AABB Annual Meeting.Kuehnert Kuehnert et al. Transfusionet al. Transfusion 2001;41:1493-9. 2001;41:1493-9.
U.S. Bacterial Contamination EstimatesU.S. Bacterial Contamination EstimatesBased on BaCon Preliminary DataBased on BaCon Preliminary Data
Platelet contamination rate:Platelet contamination rate:USUS 670/million units 670/million units (Transfusion 1999;39:36S)(Transfusion 1999;39:36S)GermanyGermany 1300 1300 (Transfusion 1999;39:34S)(Transfusion 1999;39:34S)SpainSpain 320 320 (Transfusion 1999;39:75S)(Transfusion 1999;39:75S)
Frequency of ContaminationFrequency of ContaminationOther ReportsOther Reports
Frequency of ContaminationFrequency of ContaminationOther ReportsOther Reports
Ness PM Ness PM et al. Transfusionet al. Transfusion 2001;41:857-61. 2001;41:857-61.Recalculation: LJ Dumont.Recalculation: LJ Dumont.
Plt ConcPlt Conc SDPSDPPost-transfusion sepsis Post-transfusion sepsis 402/million402/million 75/million75/millionFatalitiesFatalities 62/million 62/million 14/million14/million
Based on Johns Hopkins’ DataBased on Johns Hopkins’ Data
Detecting Bacteria in Platelets: InspectionDetecting Bacteria in Platelets: Inspection
Changes Associated with ContaminationChanges Associated with Contamination
ClotsClotsDiscolorationDiscolorationGas bubblesGas bubbles
Detecting Bacteria in Platelets: Microscopic ReviewDetecting Bacteria in Platelets: Microscopic Review
Sensitivity:Sensitivity:Gram stainGram stain 101055 - 10 - 1066/mL/mLAcridine orangeAcridine orange 101044 - 10 - 1066/mL/mL
Barrett Barrett et al. Transfusionet al. Transfusion 1993;33:228-4. 1993;33:228-4.
Detecting Bacteria in Platelets: Microscopic ReviewDetecting Bacteria in Platelets: Microscopic Review
Sensitivity:Sensitivity:Gram stainGram stain 101055 - 10 - 1066/mL/mLAcridine orangeAcridine orange 101044 - 10 - 1066/mL/mL
But: Significant But: Significant false positivefalse positive rate rate
Barrett Barrett et al. Transfusionet al. Transfusion 1993;33:228-34. 1993;33:228-34.
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
GLUCOSEGLUCOSE ACID + COACID + CO22
Decreased glucoseDecreased glucoseDecreased pHDecreased pHDecreased/absent swirlingDecreased/absent swirling
Direct detectionDirect detection
GLUCOSEGLUCOSE ACID + COACID + CO22
Decreased glucoseDecreased glucoseDecreased pHDecreased pHDecreased/absent swirlingDecreased/absent swirling
• • Automated testingAutomated testing• • Biochemical stripsBiochemical strips
Direct detectionDirect detection
• • Sensitive labelsSensitive labels• • Automated cultureAutomated culture
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
COCO22-sensitive labels on platelet bags:-sensitive labels on platelet bags:No change withNo change with Staph. epiStaph. epi
Staph. aureusStaph. aureusPs. aeruginosaPs. aeruginosaBacillus cereusBacillus cereus
Change only withChange only with Ent. aerogenesEnt. aerogenes• • at > 10at > 1066 CFU/mL CFU/mL• • sensitivity = 20%sensitivity = 20%
Specificity problem: Platelets produce COSpecificity problem: Platelets produce CO22 also. also.
Hogman CF, Gong J. Hogman CF, Gong J. Vox SangVox Sang 1994;67:351-5. 1994;67:351-5.
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
0102030405060708090
100
0 1 2 3 4 5
ControlBacillusKlebsiella
Glucose, % Day 0
Storage Time, d
data from Burstain JM data from Burstain JM et al. Transfusionet al. Transfusion 1997;37:255-8. 1997;37:255-8.
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
0102030405060708090
100
0 1 2 3 4 5
ControlBacillusKlebsiella
Glucose, % Day 0
Storage Time, d
after Burstain JM after Burstain JM et al. Transfusionet al. Transfusion 1997;37:255-8. 1997;37:255-8.
-2 SD-2 SD
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
SwirlingSwirling
Low pHLow pHMetabolic disturbanceMetabolic disturbance
No alignment with flowNo alignment with flow
Alignment with flowAlignment with flow
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
Swirling to detect contaminationSwirling to detect contamination SensitivitySensitivity SpecificitySpecificity
S. epi.S. epi. 25% 25% (Day 5)(Day 5) 75% 75%S. aureusS. aureus 100% 100% (Day 2-3)(Day 2-3) 100% 100%SalmonellaSalmonella 75% 75% (Day 3-5)(Day 3-5) 100% 100%
Leach MF Leach MF et al. Vox Sanget al. Vox Sang 1998;74(suppl 1):1180. 1998;74(suppl 1):1180.
Detecting Bacteria in Platelets: Biochemical ChangesDetecting Bacteria in Platelets: Biochemical Changes
Wagner SJ, Robinette D.Wagner SJ, Robinette D. Transfusion Transfusion 1996;36:989-93. 1996;36:989-93.
False positive rates False positive rates (sterile units)(sterile units)
Glucose:Glucose: 5%5%pH:pH: 4%4%Swirling:Swirling: 5%5%
based on ±2 SD reference intervalsbased on ±2 SD reference intervals
Brecher Brecher et al. Transfusionet al. Transfusion 1993;33:450-7. 1993;33:450-7.Fenwick Fenwick et al. Lancetet al. Lancet 1991;337:496-7 1991;337:496-7
Detecting Bacteria in Platelets: Future DevelopmentsDetecting Bacteria in Platelets: Future Developments
PCRPCREIAEIA%O%O22
Others….Others….
Traditional ConceptTraditional Concept
BLOOD CENTER
Culture: Day 1Culture: Day 1Hold until negativeHold until negative
HOSPITALDay 2 or 3Day 2 or 3
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
Traditional ConceptTraditional Concept
BLOOD CENTER
Culture: Day 1Culture: Day 1Hold until negativeHold until negative
HOSPITALDay 2 or 3Day 2 or 3
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
- Currently in routine use in blood centers in Belgium- Currently in routine use in blood centers in Belgiumand the Netherlandsand the Netherlands
- Potential difficulties with recall, outdating.- Potential difficulties with recall, outdating.
New Concept: New Concept: Hospital-BasedHospital-Based Verification of Sterility Verification of Sterility
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
(5 mL via SCD)(5 mL via SCD)
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
Detecting Bacteria in Platelets: CulturingDetecting Bacteria in Platelets: Culturing
Organisms Involved in Blood Unit ContaminationOrganisms Involved in Blood Unit Contamination1998 - 20001998 - 2000
Gram-positive (60%)Gram-positive (60%) Gram-negative (40%)Gram-negative (40%)Staph. epiStaph. epi* * (8)(8) E. coliE. coli (5)(5)
Staph. aureusStaph. aureus (4)(4) Serratia marcescensSerratia marcescens* * (3)(3)
Staph. agalactiaeStaph. agalactiae (2)(2) Serratia liquifaciensSerratia liquifaciens* * (2)(2)
Grp G Strep.Grp G Strep. (1)(1) Enterobacter aerogenesEnterobacter aerogenes (1)(1)
Staph. lugdensisStaph. lugdensis (1)(1) Enterobacter cloacaeEnterobacter cloacae (1)(1)
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)
16 initial positives 16 initial positives (0.6%)(0.6%)
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)
Day 2: CultureDay 2: CultureDay 3 AM: Split A’s culture growthDay 3 AM: Split A’s culture growth
(recultured)(recultured)
Day 3 PM: Split B’s culture growthDay 3 PM: Split B’s culture growth
Same Same Staph. epiStaph. epi. in each unit.. in each unit.
July, 2001July, 2001
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Costs:Costs:
Material costs: $11.05/plateletpheresis unitMaterial costs: $11.05/plateletpheresis unitTech time: 7 minutesTech time: 7 minutesWorkup of positives: $50-100Workup of positives: $50-100
Cooper L Cooper L et al. Transfusionet al. Transfusion 1999;39:119-20S. 1999;39:119-20S.
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Cost (for 100 units):Cost (for 100 units):
Material costs: Material costs: $1105$1105Tech time: 700 minutes Tech time: 700 minutes $467 $467Workup of positive: Workup of positive: $75$75
$1647$1647
Units not outdated:Units not outdated:1515 @ $500 @ $500 $7500$7500
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Potential payback: Outdate extensionPotential payback: Outdate extension
Units expiringUnits expiring Units requestedUnits requested on next dayon next day
2.4±1.42.4±1.4 4.8±2.4 4.8±2.4 (1-5)(1-5) (2-9) (2-9)
In all cases, more units were requested than expired.
BUT: Do 7 day old platelets survive and function?BUT: Do 7 day old platelets survive and function?
Leach MF, AuBuchon JP. Leach MF, AuBuchon JP. TransfusionTransfusion 1993;33:661-4. 1993;33:661-4.
0
2000
4000
6000
8000
10000
12000
1 2 3 4 5
15 min CCI
Storage Time (d)
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
Adrienne Johnson, BSAdrienne Johnson, BSGambro Gambro Pamela H. Whitley, MT(ASCP)SBBPamela H. Whitley, MT(ASCP)SBBLarry DumontLarry DumontArt HamstraArt HamstraTania VandenBroeke, MT(ASCP)Tania VandenBroeke, MT(ASCP)
Trima™Trima™Spectra™ LRS TurboSpectra™ LRS Turbo
LR SDPLR SDP
Day
1Day
5Day
7
Flatbed agitation, 22-24°C
Biochemical assaysBiochemical assaysFunctional assaysFunctional assays5151Cr/Cr/111111In recoveryIn recovery
and survivaland survival
XXXXXX
XXXXXX
XXXX
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
Unit contentsUnit contentsPlatelets:Platelets: 4.1±1.1x104.1±1.1x101111
Leukocytes:Leukocytes: 5.0x105.0x104 4 (median)(median)
Volume:Volume: 269±68 mL269±68 mL
Mean ± 1 SDMean ± 1 SD
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
0
20
40
60
80
100
120
140
1 5 7
pCO2
pO2
6
6.2
6.4
6.6
6.8
7
7.2
7.4
7.6
1 5 7
pH (22C)
pCO2
pO2
pH (22°C)
Storage Time (d)
mm
Hg
Storage Time (d)
*
*
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
Gluc, Lact, RateGluc, Lact, Rate
0
2
4
6
8
10
12
14
1 5 7
Lactate (mmol/10 plt)
Glucose (mmol/10 plt)
Mean± 1 SEMMean± 1 SEM
*
*
Rates: No difference
Storage Time (d)
12
12
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
0
10
20
30
40
50
60
1 5 7
P-Selectin
HSR
ESC
Storage Time (d)
%
*
*
*
Mean± 1 SEMMean± 1 SEM
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
0
20
40
60
80
100
120
140
160
180
Recovery (%)Survival (h)
Day 5 Day 7
*
*
Mean± 1 SEMMean± 1 SEM
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
5 Days5 Days 7 Days7 DaysRecoveryRecovery
This studyThis study 63±11%63±11% 54±14%54±14%Archer et al., 1983Archer et al., 1983 59±17%59±17% 46±8%46±8%
SurvivalSurvivalThis studyThis study 6.7±1.6d6.7±1.6d 5.6±1.9d5.6±1.9dArcher et al., 1983Archer et al., 1983 3.4±1.5d3.4±1.5d 2.7±0.5d2.7±0.5d
Archer Archer et al. Vox Sanget al. Vox Sang 1982; 43:223-30. 1982; 43:223-30.Mean ± 1SDMean ± 1SD
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
5 Days5 Days 7 Days7 DaysRecoveryRecovery
This studyThis study 63±11%63±11% 54±14%54±14%Archer Archer et al.et al. 59±17%59±17% 46±8%46±8%
SurvivalSurvivalThis studyThis study 6.7±1.6d6.7±1.6d 5.6±1.9d5.6±1.9dArcher Archer et al.et al. 3.4±1.5d3.4±1.5d 2.7±0.5d2.7±0.5d
Archer Archer et al. Vox Sanget al. Vox Sang 1982; 43:223-30. 1982; 43:223-30.Mean ± 1SDMean ± 1SD
THIS STUDY: THIS STUDY: Better results thanBetter results than
accepted previouslyaccepted previously
66
A Controlled Trial of 5 vs. 7 Day Platelet StorageA Controlled Trial of 5 vs. 7 Day Platelet Storage
5 Days5 Days 7 Days7 DaysRecoveryRecovery
This studyThis study 63±11%63±11% 54±14%54±14%Archer et al., 1983Archer et al., 1983 59±17%59±17% 46±8%46±8%
SurvivalSurvivalThis studyThis study 6.7±1.6d6.7±1.6d 5.6±1.9d5.6±1.9dArcher et al., 1983Archer et al., 1983 3.4±1.5d3.4±1.5d 2.7±0.5d2.7±0.5d
Archer Archer et al. Vox Sanget al. Vox Sang 1982; 43:223-30. 1982; 43:223-30.Mean ± 1SDMean ± 1SD
THIS STUDY: THIS STUDY: Better results thanBetter results than
accepted previouslyaccepted previouslyTHIS STUDY: THIS STUDY:
Less reductionLess reductionD5 D7D5 D7
14 vs. 22%14 vs. 22%
18 vs. 21%18 vs. 21%
66
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Day
2Day
5Day
7
Flatbed agitation, 22-24°CDay
6
LRSDP
OUTDATEOUTDATE
Day
8
TransfuseTransfuseif no otherif no other
units units availableavailable
pH andswirlingchecks
DetermineDetermineCCICCI
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Day 8 analysisDay 8 analysis (n = 91)(n = 91)
Swirling:Swirling: 96%96%pH:pH: 6.86±0.2456.86±0.245
> 6.2 in 97%> 6.2 in 97%Max = 7.26Max = 7.26
All units collected on Spectra™ LRS TurboAll units collected on Spectra™ LRS Turbo
Practical Application of Culturing Practical Application of Culturing in a Transfusion Service Laboratoryin a Transfusion Service Laboratory
Transfusions beyond Day 5Transfusions beyond Day 5 (n=40)(n=40)
All with expected clinical resultsAll with expected clinical results
Stable patients with 10-60 min CCI: 21Stable patients with 10-60 min CCI: 21
All units collected on Spectra™ LRS TurboAll units collected on Spectra™ LRS Turbo
0
5000
10000
15000
20000
25000
30000
35000
40000
45000
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
CCI
CCI at Day 6-7: 14,400±8,800 Median: 12,191 (n=21)CCI at Day 6-7: 14,400±8,800 Median: 12,191 (n=21)
Clinical Effect of Transfusing Platelets Beyond Day 5Clinical Effect of Transfusing Platelets Beyond Day 5
0
10
20
30
40
50
60
70
80
90
100
5000
1000
0
1500
0
2000
0
2500
0
3000
0
3500
0
4000
0
4500
0
CCI
Clinical Effect of Transfusing Platelets Beyond Day 5Clinical Effect of Transfusing Platelets Beyond Day 5
Cu
mu
l at i
ve
Pr o
po
rtio
n (
%)
90% > 7,50090% > 7,500 (All but 1: > 5,000)(All but 1: > 5,000)
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 1111CULTURECULTURE
+ 7d+ 7d
NO NO CULTURECULTURE
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 10 10 1111 11 11
Per-unit HIV risk: 1/1,000,000Per-unit HIV risk: 1/1,000,000
Risks expressed per millionRisks expressed per million
NO NO CULTURECULTURE
CULTURECULTURE+ 7d+ 7d
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 10 10 7070 8080 1111 11 11 0 0 1111
Per-unit HIV risk: 1/1,000,000Per-unit HIV risk: 1/1,000,000Septic mortality: 1/140,000Septic mortality: 1/140,000
Risks expressed per millionRisks expressed per million
NO NO CULTURECULTURE
CULTURECULTURE+ 7d+ 7d
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 10 10 7070 8080 $5,000$5,000 0 0 $5,000$5,000 1111 11 11 0 0 1111 $5,500$5,500 $220$220 $5,720$5,720
Per-unit costs:Per-unit costs:SDP:SDP: $500$500Culture:Culture: $20$20
Risks expressed per millionRisks expressed per million
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
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 10 10 7070 8080 $5,000$5,000 0 0 $5,000$5,000 1111 11 11 0 0 1111 $5,500$5,500 $220$220 $5,720$5,720
Per-unit costs:Per-unit costs:SDP:SDP: $500$500Culture:Culture: $20$20
Risks expressed per millionRisks expressed per million
$65/unit$65/unitNO 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
PltPlt HIVHIV Septic Septic TotalTotal Units’Units’ CulturingCulturing Total DirectTotal DirectTrxnTrxn RiskRisk MortalityMortality RiskRisk CostCost CostCost CostCost
1010 10 10 7070 8080 $5,000$5,000 0 0 $5,000$5,000 1111 11 11 0 0 1111 $5,500$5,500 $220$220 $5,720$5,720
What if 7d platelets aren’t quite as good? What if 7d platelets aren’t quite as good?
Per-unit costs:Per-unit costs:SDP:SDP: $500$500Culture:Culture: $20$20
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
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