GambroFenwal PASSPORT Post Marketing Study 7 Day Platelets Blood Products Advisory Committee Rockvil - PowerPoint PPT Presentation

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GambroFenwal PASSPORT Post Marketing Study 7 Day Platelets Blood Products Advisory Committee Rockvil

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Title: GambroFenwal PASSPORT Post Marketing Study 7 Day Platelets Blood Products Advisory Committee Rockvil


1
Gambro/Fenwal PASSPORT Post Marketing Study 7
Day Platelets Blood Products Advisory
CommitteeRockville, MDMay 1, 2008
  • Larry J. Dumont, MBA, PhD
  • Dartmouth-Hitchcock Medical Center
  • Lebanon, New Hampshire

2
Conflicts of Interest
  • Consultant
  • Gambro BCT
  • bioMérieux
  • BCSI
  • Verax Biomedical
  • Research support DHMC
  • Cerus
  • Fenwal
  • Gambro BCT
  • Haemonetics
  • Immunetics
  • Navigant Biotechnologies
  • Verax Biomedical
  • Travel Support
  • FDA

3
Important Facts!
  • 7-day platelets are 510(k) cleared by FDA
  • Gambro BCT, Inc.
  • Fenwal, Inc.
  • PASSPORT The post-marketing surveillance of
    7-day platelets (a.k.a., Phase IV trial)
  • Not IND or IDE study as a prerequisite for
    clearance
  • PASSPORT has
  • An explicitly stated primary hypothesis with a
    written analysis plan which was reviewed and
    accepted by FDA
  • The planned analysis has not been conducted and
    the primary hypothesis has not been tested

4
Important Facts!
  • Assumptions
  • True contamination rate
  • 178/M (1/5618) to 349/M (1/2865), based on one
    bottle testing
  • The Release Test would detect at least 50
  • Therefore, residual risk 100/M (1/10,000)
  • This lead to the SAMPLE size calculation
  • ? 4 positive out of 50K surveillance tests
  • Upper 95 CL of no more than 1/5K (200/M)
    residual risk
  • NB These risks are NOT weighted for the clinical
    risk that may be presented by organism or day the
    organism may be detectable.

5
Important Facts!
  • Assumptions
  • True contamination rate
  • 178/M (1/5618) to 349/M (1/2865), based on one
    bottle testing
  • The Release Test would detect at least 50
  • Therefore, residual risk 100/M (1/10,000)
  • This lead to the SAMPLE size calculations
  • ? 4 positive out of 50K surveillance tests
  • Upper 95 CL of no more than 1/5K (200/M)
    residual risk
  • NB These risks are NOT weighted for the clinical
    risk that may be presented by organism or day the
    organism may be detectable.

6
SEPT 2003 7-day platelet function OK
7
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8
7-Day Platelet Release Test
  • Sampling 24 - 36 h post apheresis collection
  • 4-5 mL aliquots of SDP in both
  • one aerobic and one anaerobic culture bottles
  • Release if no growth indicated after 24 h on test
  • Culture bottles remain on test until positive or
    SDP expiry
  • Standard practices indicated for microbiology and
    clinical follow-up for any positive cultures.

9
PASSPORT - Post Marketing Surveillance
7-Day Apheresis Platelets
Tier 2
D1
Surveillance Test 2 bottle N 50,000
Release Test 2 bottle
Incubate
Incubate 7d
Data Analysis
10
PRIMARY HYPOTHESIS
  • 7 Day SDP when tested using the BTA Device and
    Methods as described (i.e., at 24-36 hours post
    collection, aerobic and anaerobic bottles) will
    not present a greater risk of a detectable
    bacterially contaminated platelet unit than 5 Day
    SDP untested for bacterial contamination.

New endpoint for a modified study design
estimate residual bacterial risk for a 7 day old
platelet unit tested for bacteria on day 1.
Approve 7 day platelet storage if the bacterial
risk at day 7 is lower than the current bacterial
risk of untested platelet products. FDAs
Current Thinking on Bacterial Detection in
Platelets. ACBSA. August 27, 2004
11
SPECIFIC AIMS
  • Determine the Specificity, Sensitivity, Negative
    Predictive Value, and Positive Predictive Value
    of the 2-bottle Release Test.
  • Determine prevalence of bacterial contamination
    for untested and for 2 bottle BTA tested SDP.
  • Determine performance contribution of the
    anaerobic bottle to the BTA and assess the need
    for anaerobic culturing in this application.

12
7 Day Platelet Adoption in the US
March
2008
33 organizations (51 centers) Participating
Nationwide
(5)
Implemented 7DP
13
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14
Surveillance through 11 Feb 2008
15
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16
Release Test
  • Double product day 6 transfusions one
    patient with fever CNS blood and unit
  • Double product day 4 transfusions STR 6-8h
    post both pts staph aureus

AABB Bulletin 04-07, Oct 2004
17
Surveillance Test
  • 4369 tested after day 7
  • 3 True Positives
  • 686/M (95CI 142 2005)
  • Unit 1 Staph Aureus, BPA 3.7h BPN 7.2h,
    confirmed
  • Unit 2 Split donation Staph epi BPA 7.2h BPN
    4.3h Second bag transfused on day 4 with no
    adverse reaction reported
  • Unit 3 Strep veridans BPA 30.8h BPN 9.6h
    confirmatory test diphtheroid like gram positive
    rods

18
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19
3 / 4369
7 / 8282
6 / 6438
20
2-Bottle Results
based on clinical reports
21
True Positive Both Bottles
22
True Positive One Bottle Only
typically obligate anaerobe
23
Clinical Outcomes
  • 13 true positive, 202 indeterminate transfused
  • No deaths Reported
  • 14 transfusion reactions related to bacterial
    contamination
  • 44/M (24-73)

24
Clinical Outcomes - 1
25
Clinical Outcomes - 2
26
Clinical Outcomes - 3
27
Summary
  • 2-bottle Release Test
  • True Positive 234/M (184-293)
  • True Pos Indeterminate 1003/M (897-1118)
  • Generally consistent with other reports
  • 256 collections not interdicted prior to
    transfusion
  • Surveillance
  • 686/M (95CI 142 2005)
  • Generally consistent with other reports
  • No deaths reported
  • Ness et al. 15/M
  • 14 transfusion reactions
  • 44/M (24-73)
  • Ness et al. 70/M donations (49-105)

28
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