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5 Day Plasma


Jane12

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We did this a few years ago.  Our medical director is conservative, and we sacrificed several FFP - thawed them and took samples for factor assays.  Then repeated factor assays at 24 hrs, 48, 72...  What you really just want to show is that x% of factors are still present at 5 days.  So you just need to set what x% is acceptable.  I think we set 80% of FVII and fibrinogen. 

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Both the Technical Manual and Circular of Information include a table from a paper published a while back (2009) showing how the various factor and proteins C and S and anti-thrombin persist (or not) over 5 days.

It's really not pretty but here is a copy/paste from the circular of information, which is also available from AABB (direct link, go to page 14 for easier reading of the table)

I do QA and software support now, so read your question as about validating the computer/labeling process. Our facility skips the 24 hour FFP step, so when we thaw a plasma it is immediately re-labeled as 5 day Thawed Plasma

[looks like our study results might not have passed at Kate's place, only about 70% of FVII remained after 5 days at 1-6 in FFP, but the FP24 would pass (it started lower but retained 86% of activity).]

Table 3a. Coagulation Factor Activity in FFP and PF24 (whole blood) at the Time of Thaw and after 120 Hours of 1 to 6 C Storage

(adapted from Table 1. Scott EA, et al. Transfusion 2009;49:1584-91)

Thaw, mean ± SD (range) by product

120 hr, mean (range) by product

%Change after 120 hr at 1 to 6 C

Analyte

FFP (n=20)

PF24 (n=14)*

FFP (n=20)

PF24 (n=14)*

FFP

PF24

FII (IU/dL)

97 ± 10 (83-125)

97 ± 8 (80-113)

95 ± 10 (82-126)

96 ± 11 (74-120)

3‡

1

FV (U/dL)

85 ± 13 (63-104)

86 ± 16 (54-124)

67 ± 19 (17-92)

59 ± 22 (15-109)

21‡

31‡

FVII (IU/dL)

105 ± 25 (50-163)

89 ± 22 (54-145)

70 ± 18 (34-102)

77 ± 27 (50-159)

33‡

14‡

FVIII (IU/dL)§

81 ± 19 (47-117)

66 ± 17 (30-100)†

43 ± 10 (27-60)

48 ± 12 (26-73)

47‡

28‡

F IX (IU/dL)

82 ± 13 (62-108)

88 ± 13 (70-105)

80 ± 12 (64-107)

84 ± 12 (65-99)

2

4‡

FX (IU/dL)

94 ± 10 (71-112)

94 ± 11 (72-112)

87 ± 11 (65-111)

91 ± 12 (67-114)

7‡

3‡

vWF:Ag (IU/dL)§

98 ± 27 (57-156)

132 ± 41 (78-211)

97 ± 30 (48-150)

127 ± 40 (79-224)

1

4

vWF:RCo (IU/dL)§

101 ± 26 (61-152)

123 ± 47 (58-238)

93 ± 30 (48-149)

102 ± 38 (50-191)

8‡

17‡

Fibrinogen (mg/dL)

280 ± 52 (223-455)

309 ± 70 (211-500)

278 ± 50 (223-455)

303 ± 50 (205-490)

1

2‡

Anti-thrombin (IU/dL)

97 ± 9 (85-118)

97 ± 11 (77-110)

100 ± 10 (85-131)

101 ± 14 (73-116)

3

4‡

Protein C (IU/dL)

107 ± 20 (74-148)

88 ± 16 (65-120)

107 ± 19 (77-148)

89 ± 17 (65-115)†

0

2

Protein S (IU/dL)

97 ± 18 (61-123)

92 ± 18 (54-121)

90 ± 22 (52-134)

78 ± 19 (46-114)†

7‡

15‡

*N = 25 for FII, FV, FVIII, Fibrinogen, vWF:RCo, and Protein S.

p < 0.05 compared with mean activity in FFP of the same age.

p < 0.05 when comparing mean activity at thaw to mean activity after 120 hours of 1 to 6 C storage.

§Only results from group O products were used for statistical comparisons of factor VIII, vWF:Ag, and vWF:RCo activities.

 

Edited by Eman
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Here's another useful paper, it was the model for the study reported above (and they had a bit better FVII retention).

http://onlinelibrary.wiley.com/doi/10.1046/j.1537-2995.2001.41040570.x/full

Serial measurement of clotting factors in thawed plasma stored for 5 days

Authors

Katharine A. Downes MD,

Erica Wilson MD,

Roslyn Yomtovian MD,

Ravindra Sarode MD

First published: April 2001

 

able 1.  Mean coagulation factor levels at 24-hour intervals by blood group
  Level*    
Coagulation factor Day 1 Day 2 Day 3 Day 4 Day 5 Mean change from Day 1 to Day 5 (%) p values
  1. * Mean ± SD.

  2. † Comparison of FVIII activity at Day 1 and that at Day 3 was statistically significant.

FVIII (%)              
Blood group A 107 ± 26 76 ± 19 66 ± 18 65 ± 17 63 ± 16 41 <0.004†
Blood group B 103 ± 44 74 ± 37 71 ± 35 67 ± 36 67 ± 33 35 <0.02†
Blood group O 70 ± 16 51 ± 10 43 ± 10 43 ± 7 41 ± 8 41 <0.001†
Factor II (%) 81 ± 9 81 ± 9 81 ± 9 80 ± 10 80 ± 10 1 NS
Factor V (%) 79 ± 7 75 ± 8 71 ± 9 68 ± 9 66 ± 9 16 NS
Factor VII (%) 90 ± 18 81 ± 15 76 ± 15 72 ± 14 72 ± 15 20 NS
Factor X 85 ± 13 84 ± 13 84 ± 15 82 ± 11 80 ± 11 6 NS
Fibrinogen (mg/dL) 225 ± 12 224 ± 13 224 ± 13 224 ± 17 225 ± 12 0 NS

 

 

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Awesome details. Thanks for all the information. I worked at couple of facilities that switched to 5 day plasma and I do not remember them doing any factor studies. They did a lots of validation with the ISBT labels. I do not remember the exact details. My supervisor said that since it has been approved by FDA, we do not need to repeat the factor studies but, has to make sure that the thawed labels match the product code for the frozen product. Is that right ? 

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9 hours ago, Jane12 said:

My supervisor said that since it has been approved by FDA, we do not need to repeat the factor studies but, has to make sure that the thawed labels match the product code for the frozen product. Is that right ? 

That's my understanding.  We did label validation when we got plasma frozen < 24 hours, since it is labeled as thawed plasma.

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10 hours ago, Jane12 said:

Awesome details. Thanks for all the information. I worked at couple of facilities that switched to 5 day plasma and I do not remember them doing any factor studies. They did a lots of validation with the ISBT labels. I do not remember the exact details. My supervisor said that since it has been approved by FDA, we do not need to repeat the factor studies but, has to make sure that the thawed labels match the product code for the frozen product. Is that right ? 

I had hoped that the validation mania had subsided.  It's good to see that there is still some common sense out there.  I never did understand why so many of us felt the need to continually reinvent the square wheel when all the work on the round one had already been completed.  :highfive: 

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Neil is correct, there was some kind of regulatory change around 5-10 years ago so 5 day Thawed Plasma is legal now, no variances required. [I think the change was officially recognizing the 5 day product.] Also agree that validation of the plasma contents is not required, just validate your computer/label processes. Our frozen product is immediately relabeled as E2720 (Plasma, thawed, CP2D) upon thawing, given the 5 day expiration right away.

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On 11/6/2017 at 4:59 AM, Neil Blumberg said:

Don't believe you need a variance or validation.  Just relabel the product before 24 hours is up.  The product is liquid plasma, not FFP after 24 hours.

From my understanding, liquid plasma is plasma that has never been frozen and has a much longer outdate.  We order it specifically from our supplier.

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