M. Taher Shabani-Rad Susan Nahirniak NAC Meeting Nov Toronto

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Presentation transcript:

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

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

Factor Contents of Cryopercipitate 10 Units-(Adult DoseX1) & Normal Range Tx Abnormal Level Half-Life CryoP Content (10U= 1 Dose) Fibrinogen 1.6-4.1 gr/L <1.5 gr/L 4 days 2.85 gr/10 U (75%) VWF 0.41-1.44 U/ml <0.5 U/ml 12 hours Factor VIII 0.54-1.57 U/ml <25% activity 8-12 hours Factor XII >75% Control (Qualitative) <5% of normal 9-10 days

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

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

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)

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 1.5-1.95 42 22 18 2 Pre Fib 1.0-1.5 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 >1.0-1.5 63 41 19 Post Fib 1.5-1.95 72 45 24 Post Fib > 2.0 53 26

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%)

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%)

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 1.5-1.95 79 43 17 8 Pre Fib 1.0-1.5 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 1.0-1.45 48 7 13 4 Post Fib 1.5-1.95 103 50 20 12 Post Fib > 2.0 180 24 106 47

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%)

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%)

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%)

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

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%)

Discussion