1. M. Taher Shabani-Rad Susan Nahirniak NAC Meeting Nov 2017 - Toronto
FC (RiaSTAP) vs Cryo
M. Taher Shabani-Rad
Susan Nahirniak
NAC Meeting Nov Toronto

2. Objectives
Evaluation of Fibrinogen increment after infusion of low dose RiaSTAP (1 gr) vs Medium (2gr) vs high dose (3/4 gr or >4gr)
Is Cryo replaceable by RiaSTAP?
Development of dose recommendation based on clinical indications/companion Lab tests (Pending)
The Cost Impact of Cryo replacement by RiaSTAP

3. Factor Contents of Cryopercipitate 10 Units-(Adult DoseX1) & Normal Range
Tx Abnormal Level
Half-Life
CryoP Content
(10U= 1 Dose)
Fibrinogen
gr/L
<1.5 gr/L
4 days
2.85 gr/10 U (75%)
VWF
U/ml
<0.5 U/ml
12 hours
Factor VIII
U/ml
<25% activity
8-12 hours
Factor XII
>75% Control
(Qualitative)
<5% of normal
9-10 days

4. Factor Levels of patients requiring Cryopercipitate/RiaSTAP (28 Pts)
Question: Which bleeding patients require Cryo vs RiaSTAP?
Patients with isolated Fibrinogen deficiency may require RiaSTAP
Patients with combined factor deficiency may require Cryo-Percipitate
Normal
Elevated
Low
Total
Fibrinogen 3 25 28
VWF 6 21 27
Factor VIII 12 11 5
Factor XIII
Not measured

5. Patients with Decreased Factor VIII Levels Normal Range (0.54-1.44)
VIII (C: U/ml)
vWF:Act U/ml
vWF: Ag U/ml
Fibrinogen
Pt #27
0.34
0.81
0.99
0.9
Pt #25
0.47
1.55
2.04
0.4
Pt #18
0.52
Failed
1.17
Pt #6
1.41
1.61
0.6
Pt #5
0.19
3.01
2.46
0.8

6. Could Fibrinogen Levels be predictor of patients requiring Cryo vs RiaSTAP
Low VIII
Normal VIII
Elevated VIII
Total# Pts
# Pts 5 12 11 28
Fib<1.0 gr/L 3 13
Fib>1.0 gr/L 7 8 15
Fib<1.0 gr/L (%)
%100
42%
27%
46%
Further consideration: Integration of clinical category, INR & PTT to separate patients requiring Cryo vs RiaSTAP (without measuring factor VIII levels)

7. Pre and Post infusion Feb Levels- CZ (1) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
CLS-CZ
# Pts
# Pts (RSTP 1gr)
# Pts (RSTP 2gr)
# Pts (RSTP ≥4gr)
Pre Fib > 2.0 15 10 5
Pre Fib 42 22 18 2
Pre Fib 77 44 36 7
Pre Fib <1.0 79 54 23
Total # of Patients
213
130 82 11
Post Fib NS <1.0 25 21 3 1
Post Fib > 63 41 19
Post Fib 72 45 24
Post Fib > 2.0 53 26

8. Pre and Post infusion Feb Levels- CZ (2) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
CLS-CZ
# Pts
# Pts (RSTP 1gr)
# Pts (RSTP 2gr)
# Pts (RSTP ≥4gr)
Pre Fib >1.5
57 (27%)
32 (25%)
23 (28%)
2 (18%)
Pre Fib <1.5
156 (73%)
98 (75%)
59 (72%)
9 (82%)
Total # of Patients
213
130 82 11
Post Fib <1.5
88 (41%)
62 (48%)
22 (27%)
4 (36%)
Post Fib >1.5
125 (59%)
68 (53%)
50 (73%)
7 (64%)

9. Pre and Post infusion Feb Levels- CZ (3) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)57
# Pts
# Pts (RSTP 1gr)
# Pts (RSTP 2gr)
# Pts (RSTP ≥4gr)
Pre Fib >1.5
57 (27%)
32 (25%)
23 (28%)
2 (18%)
Pre Fib <1.5
156 (73%)
98 (75%)
59 (72%)
9 (82%)
Total # of Patients
156 98 59 9
Post Fib <1.5
88 (57%)
62 (63%)
22 (37%)
4 (44%)
Post Fib >1.5
68 (43%)
36 (37%)
37 (63%)
5 (56%)

10. Pre and Post infusion Feb Levels- EZ (1) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
#Pts
# Pts (RSTP) 1gr
# Pts (RSTP) 2gr
# Pts (RSTP) ≥4gr
# Pts (RSTP) 3gr
Pre Fib > 2.0 80 11 52 6
Pre Fib 79 43 17 8
Pre Fib 98 14 49 25
Pre Fib <1.0
105 53 35 9
Total # of Patients
362 44
197 88 34
Post Fib <1.0 31 16 1
Post Fib 48 7 13 4
Post Fib
103 50 20 12
Post Fib > 2.0
180 24
106 47

11. Pre and Post infusion Feb Levels- EZ (2) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
#Pts
# Pts (RSTP) 1gr
# Pts (RSTP) 2gr
# Pts (RSTP) ≥4gr
# Pts (RSTP) 3gr
Pre Fib >1.5
159 (44%)
22 (50%)
95 (48%)
28 (32%)
14 (41%)
Pre Fib <1.5
213 (56%)
102 (52%)
60 (68%)
20 (59%)
Total # of Patients
362 44
197 88 34
Post Fib <1.5
79 (22%)
13 (30%)
41 (21%)
21 (24%)
5 (15%)
Post Fib >1.5
283 (78%)
31 (70%)
156 (79%)
67 (76%)
29 (85%)

12. Pre and Post infusion Feb Levels- EZ (3) Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
#Pts
# Pts (RSTP) 1gr
# Pts (RSTP) 2gr
# Pts (RSTP) ≥4gr
# Pts (RSTP) 3gr
Pre Fib >1.5
159 (44%)
22 (50%)
95 (48%)
28 (32%)
14 (41%)
Pre Fib <1.5
213 (56%)
102 (52%)
60 (68%)
20 (59%)
Total # of Patients
213 22
102 60 20
Post Fib <1.5
79 (37%)
13 (59%)
41 (40%)
21 (35%)
5 (25%)
Post Fib >1.5
134 (63%)
9 (41%)
61 (60%)
39 (65%)
15 (75%)

13. Pre and Post infusion Feb Levels Based on RiaSTAP (1 gr vs 2 gr vs 4gr)
CZ & EZ
#Pts
# Pts (RSTP) 1gr
# Pts (RSTP) 2gr
# Pts (RSTP) ≥4gr
# Pts (RSTP) 3gr
Pre Fib >1.5
159 (44%)
22 (50%)
95 (48%)
28 (32%)
14 (41%)
Pre Fib <1.5 (CZ)
156 (73%)
98 (75%)
59 (72%)
9 (82%) NA
Pre Fib <1.5 (EZ)
213 (56%)
102 (52%)
60 (68%)
20 (59%)
CZ # of FD Patients
156 98 59 9
EZ # of FD Patients
213 22
102 60 20
Post Fib <1.5 (CZ)
88 (57%)
62 (63%)
22 (37%)
4 (44%)
Post Fib <1.5 (EZ)
79 (37%)
13 (59%)
41 (40%)
21 (35%)
5 (25%)
Post Fib >1.5 (CZ)
68 (43%)
36 (37%)
37 (63%)
5 (56%)
Post Fib >1.5 (EZ)
134 (63%)
9 (41%)
61 (60%)
39 (65%)
15 (75%)

14. Response Rate to RiaSTAP based on Pre and Post infusion Feb Levels(1 gr vs 2 gr vs 4gr)

15. Total Pts 369 110 161 69 #Pts # Pts (RSTP) 1gr # Pts (RSTP) 2gr
Total # of FD Pts
369
110
161 69
Post Fib <1.5
167 (45%)
75 (68%)
63 (39%)
25 (36%)
Post Fib >1.5
202 (55%)
45 (32%)
98 (61%)
44 (64%)

16. Discussion