Paired Comparison of Therapeutic Plasma Exchange using Fenwal Amicus vs. TerumoBCT Spectra Optia

Transcription

1 Paired Comparison of Therapeutic Plasma Exchange using Fenwal Amicus vs. TerumoBCT Spectra Optia Edwin A. Burgstaler MT, HP (ASCP) Sandra C. Bryant M.S. Jeffrey L. Winters M.D. ASFA Annual Meeting May 5, MFMER slide-1

2 Conflict of Interest Consulting:Immunocellular Therapeutics Ltd MFMER slide-2

3 Amicus Optia 2016 MFMER slide-3

4 Study Purpose Amicus vs. Optia TPE Comparison Paired-same patient Prospective Randomized first procedure Crossover 81 pairs Objectives Primary- platelet loss Secondary- procedure time, plasma CE1,plasma removal rate, fluid balance 2016 MFMER slide-4

5 Diagnosis Neurologic diseases Pairs Peripheral nerve demyelinating diseases 5 CNS demyelinating diseases 24 Myasthenia gravis 3 Autoimmune encephalomyelitis 5 Renal diseases Recurrent FSGS 11 HUS 2 Cast nephropathy 6 Fibrillary glomerulopathy 1 Hematology diseases Hyperviscosity 1 Rheumatologic diseases Vasculitis 6 Complications of transplantation Antibody mediated rejection 12 Conditioning for crossmatch incompatible transplant MFMER slide-5

6 Methods Patients and Procedures 57 patients 24 patients had two pairs 162 procedures Most procedures within two weeks 2016 MFMER slide-6

7 Methods Machine Settings Inlet rates up to 120 ml/min First machine set the inlet rate for the second AC ratios 26:1 with heparin Anticoagulant 1,000 ml ACD-A with 10,000 units heparin One plasma volume exchanged Current spun HCT used to determine plasma volume to be removed 100% fluid balance ( except 1pr +200 & 1pr -200ml) 2016 MFMER slide-7

8 Methods Replacement Fluids 5% normal serum albumin (NSA) [72 pairs] Fresh Frozen Plasma (FFP) [ 2 pairs] NSA + 3 units FFP [ 7 pairs] Saline 2016 MFMER slide-8

9 Methods Samples and Testing Pre sample-immediate or within 2 hours CBC Measure HCT and PLT Post reinfusion sample CBC Measure HCT and PLT Waste plasma sample Platelet count Measure PLT collected 2016 MFMER slide-9

10 Methods Definitions Procedure Time (PT) includes reinfusion Plasma Removed (PR) was from the machine screen Waste plasma was measured in graduated cylinder for PLT content Average inlet rate: Volume processed/ PT reinfusion time CE1= [PR/ WB processed x avg plasma %] x100 WB Processed= Volume Processed-AC used Avg plasma %= 100%- (Pre HCT+Post HCT/2) 2016 MFMER slide-10

11 Methods Statistics Multivariable general estimating equations To assess relationships between outcome variables with the machines After adjusting for covariates p-values < 0.05 considered significant 2016 MFMER slide-11

12 Total Blood Volume Medians ml p>0.99 Not Significant 0 Amicus Optia 2016 MFMER slide-12

13 Spun Hematocrits Medians % Amicus Optia p>0.23 Not Significant 2016 MFMER slide-13

14 Whole Blood Processed Medians ml p=0.048 Significant 0 Amicus Optia 2016 MFMER slide-14

15 Platelet Collection Efficiency (CE1) Medians % Amicus Optia 3.6 p= Significant 2016 MFMER slide-15

16 Platelet Count Drop Medians % p>0.57 Not Significant 2 0 Amicus Optia 2016 MFMER slide-16

17 Platelets in Waste Bag Medians x (1.1 units) p=0.35 Not Significant (0.6 units) Amicus Optia 2016 MFMER slide-17

18 Average Inlet Flow Rate Medians Ml/Min p= Significant 20 0 Amicus Optia 2016 MFMER slide-18

19 Plasma Removal Rate Medians Ml/Min p=0.061 Not Significant 20 0 Amicus Optia 2016 MFMER slide-19

20 Plasma Collection Efficiency (CE1) Medians % Amicus Optia p= Significant 2016 MFMER slide-20

21 Correlation of Inlet Rate and Plasma CE1 Amicus Optia 2016 MFMER slide-21

22 Correlation of Pre HCT to Plasma CE1 Amicus Optia 2016 MFMER slide-22

23 Procedure Time* Medians 90 M i n u t e s Mean=76 Mean=70 p> Significant 10 0 Amicus Optia * Includes Reinfusion 2016 MFMER slide-23

24 Inlet Flow Rates of 81 TPE Pairs 120 ml/min or <120 ml/min 120 ml/min 17% 83% < 120 ml/min 2016 MFMER slide-24

25 Anticoagulant to Patient Medians ml Amicus Optia 34 p= Significant 2016 MFMER slide-25

26 Fluid Balance Medians ml Amicus Optia 15 p< Significant 2016 MFMER slide-26

27 Citrate Toxicity Procedures (% of 81) Amicus Optia No calcium 62 (77%) 61 (75%) Calcium given 19 (23%) 20 (25%) 1 dose 15 (19%) 14 (17%) 2 doses 1 ( 1%) 2 (2%) 3 doses 1 (1%) 2 (2%) HUS prophylactic (1 dose) 2 (2%) 2 (2%) FFP replacement 5 (6%) 6 (7%) 1 Dose= 1.0 gram Calcium Gluconate 2016 MFMER slide-27

28 Other Reactions Symptom Machine Action Hypotensive Optia Trendelenburg position Hypotensive Amicus Dropped inlet rate Light headed Optia Prone position Light headed Optia Dropped inlet rate Dizzy Amicus Trendelenburg & drop inlet All recovered without incident 2016 MFMER slide-28

29 Conclusions Amicus and Optia are comparable for TPE Amicus better for Plasma CE1 and fluid balance Optia better for procedure time, platelet CE1, blood processed, AC to patient, inlet flow rate Other parameters were similar Significant differences were not clinically different There was a negative correlation of HCT or inlet rates to plasma collection efficiency 2016 MFMER slide-29

30 Questions & Discussion 2016 MFMER slide-30

31 Diagnosis Pairs ANCA vasculitis 3 Cross match incompatible 5 Antibody mediated rejection 12 Neuromyelitis optica 14 Multiple sclerosis 10 Myasthenia gravis 3 Susac syndrome 2 Recurrent FSGS 11 AIDP MFMER slide-31

32 Diagnosis (cont) Pairs CIDP 2 Fibrillary glomerulopathy 1 HUS 2 Myeloma cast nephropathy 6 Paraneoplastic encephalomyelitis 5 Henoch-Schonlein purpura 1 Hyperviscosity MFMER slide-32