TRIMA ACCEL

Additional Manufacturer Narrative

INVESTIGATION: THIS PROSPECTIVE STUDY AIMED TO ASSESS THE INFLUENCE OF DONOR AND MACHINE- RELATED FACTORS ON PLATELET YIELDS OBTAINED FROM THE HAEMONETICS MCS+ (B)(6) USA), TRIMA ACCEL, AND SPECTRA OPTIA (TERUMO BCT, LAKEWOOD, CO, USA) DEVICES. INITIALLY, A COMPARATIVE ANALYSIS OF 300 SESSIONS PER DEVICE WAS CONDUCTED PRIOR TO SOFTWARE UPDATES. THE STUDY FOCUSED ON THE IMPACT OF HIGH- YIELD PROCEDURES AND SYSTEM UPDATES ON DONOR SAFETY AND POST- DONATION BLOOD PARAMETERS IN TRIMA AND HAEMONETICS COLLECTIONS. ALL PROCEDURES USED A SINGLE- NEEDLE TECHNIQUE AND ACD-A AS THE ANTICOAGULANT AND THE TARGET PLATELET YIELD WAS 6¿12 × 1011. THIS TARGET YIELD SURPASSES AABB STANDARDS (= 3.0 × 1011). THIS PROSPECTIVE OBSERVATIONAL STUDY INCLUDED 1300 PLATELETPHERESIS PROCEDURES FROM HEALTHY MALE DONORS. THREE APHERESIS SYSTEMS WERE USED: ¿ HAEMONETICS MCS+ (BRAINTREE, MA, USA) [15]. ¿TRIMA ACCEL (TERUMO BCT, LAKEWOOD, CO, USA) [16]. ¿ SPECTRA OPTIA (TERUMO BCT, LAKEWOOD, CO, USA) [17]. PROCEDURES WERE DIVIDED INTO TWO COHORTS: ¿ PRE- UPDATE COHORT (900 PROCEDURES): 300 PER DEVICE BEFORE RECENT SOFTWARE UPDATES. PARAMETERS ASSESSED INCLUDED PLATELET YIELD, DONOR CHARACTERISTICS, MACHINE DATA, AND ADVERSE EVENTS. ¿ POST- UPDATE COHORT (400 PROCEDURES): 200 PROCEDURES EACH FROM TRIMA AND HAEMONETICS AFTER THEIR RESPECTIVE SOFTWARE UPDATES. PARAMETERS ASSESSED INCLUDED PLATELET YIELD, DONOR CHARACTERISTICS, MACHINE DATA, ADVERSE EVENTS, AND POST- APHERESIS BLOOD COUNTS. TWO MILD VASOVAGAL EVENTS (0.7%) WERE OBSERVED WITH THE OPTIA DEVICE, THE TRIMA DEVICE WAS ASSOCIATED WITH SEVEN ADVERSE EVENTS (2.3%). TWO DONORS EXPERIENCED HYPOTENSION AFTER PLATELET YIELDS OF 5 × 1011 AND 6 × 1011 WERE COLLECTED, RESPECTIVELY. FIVE DONORS EXPERIENCED SEVERE HYPOTENSION WITHIN THE FIRST 10 MIN, LEADING TO THE TERMINATION OF THE COLLECTION PROCEDURE. NO MACHINE MALFUNCTIONS WERE REPORTED. TRIMA DELIVERED THE HIGHEST OVERALL PLATELET COUNTS, AND OPTIA REPORTED THE LOWEST ADVERSE EVEN INCIDENCE. THE AUTHORS SOUGHT TO EVALUATE WHETHER TRIMA ACCEL AND SPECTRA OPTIA CAN PROVIDE SUPERIOR PLATELET COLLECTION EFFICIENCY AND HIGH YIELD PLATELETPHERESIS COMPARED WITH HAEMONETICS MCS+, WHILE MAINTAINING AN ACCEPTABLE DONOR SAFETY PROFILE AND DETERMINING THE EFFECT OF SOFTWARE ENHANCEMENTS ON COLLECTION PERFORMANCE. THE AUTHORS FURTHER HYPOTHESIZE THAT TRIMA ACCEL APHERESIS SYSTEMS ARE CAPABLE OF PRODUCING HIGHER PLATELET YIELDS AND/OR COLLECTING PLATELETS MORE EFFICIENTLY THAN THE HAEMONETICS DEVICE, WHILE MAINTAINING ACCURATE YIELD PREDICTIONS. DONOR FACTORS SUCH AS BODY WEIGHT AND BASELINE PLATELET COUNT ARE ASSOCIATED WITH THE ABILITY TO ACHIEVE HIGHER PLATELET COLLECTION TARGETS. THE AUTHORS CONCLUDED THAT THE OVERALL ADVERSE EVENT RATES IN THIS STUDY WERE REMARKABLY LOW DESPITE THE EMPHASIS ON HIGH YIELDS. TRIMA DELIVERED THE HIGHEST OVERALL PLATELET COUNTS, AND OPTIA REPORTED THE LOWEST ADVERSE EVENT INCIDENCE. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: HUSSEIN, E., & ENEIN, A. A. A. (2025). A PROSPECTIVE COMPARATIVE STUDY OF HIGH-YIELD PLATELETPHERESIS USING HAEMONETICS MCS +, TRIMA ACCEL, AND SPECTRA OPTIA DEVICES IN A RESOURCE-CONSTRAINED SETTING. JOURNAL OF CLINICAL APHERESIS, 40(5), E70054. HTTPS://DOI.ORG/10.1002/JCA.70054

Description of Event or Problem

PER JOURNAL ARTICLE " A PROSPECTIVE COMPARATIVE STUDY OF HIGH-YIELD PLATELETPHERESIS USING HAEMONETICS MCS+, TRIMA ACCEL, AND SPECTRA OPTIA DEVICES IN A RESOURCE-CONSTRAINED SETTING" BY EIMAN HUSSEIN, AZZA A. ABOUL ENEIN IN A RESOURCE-CONSTRAINED SETTING, MAXIMIZING PLATELETPHERESIS EFFICIENCY IS CRITICAL. WE BELIEVE LEVERAGING ADVANCED APHERESIS DEVICE SOFTWARE TO ENHANCE PLATELET YIELD, REDUCE CONSUMABLES, AND SHORTEN PROCEDURE TIMES OFFERS SIGNIFICANT ADVANTAGES. THIS STUDY COM PARED HAEMONETICS, TRIMA, AND OPTIA APHERESIS DEVICES, ANALYZING DONOR AND MACHINE PARAMETERS. IT ALSO ASSESSED HOW HIGH-YIELD COLLECTIONS AND RECENT SOFTWARE UPDATES ON TRIMA AND HAEMONETICS DEVICES IMPACT DONOR SAFETY. THE GOAL WAS TO FIND THE BEST PRAC TICES FOR OPTIMIZING BOTH DONOR SAFETY AND PLATELET COLLECTION. ANALYZING 900 PROCEDURES (300 PER DEVICE), TRIMA AND OPTIA YIELDED SIGNIFICANTLY MORE PLATELETS (9×1011) IN LESS TIME COMPARED TO HAEMONETICS (5.7×1011) (P<0.05). TRIMA COLLECTED10¿12×1011 PLATELETS FROM SIGNIFICANTLY MORE DONORS WITH LOWER PRE-DONATION COUNTS THAN OPTIA (P<0.05). OPTIA LED TO THE FEWEST ADVERSE EVENTS (0.7%). DONOR WEIGHT WAS SIGNIFICANTLY HIGHER FOR YIELDS >9×1011 ON OPTIA AND TRIMA (P<0.05). HAEMONETICS' 3.6¿3.8×1011 YIELD GROUP HAD SIGNIFICANTLY LOWER SESSION TIME, DONOR WEIGHT, AND PRESESSION PLATELET COUNTS (P<0.05). SOFTWARE UPDATES (200 SESSIONS/DEVICE) SIGNIF ICANTLY BOOSTED TRIMA'S YIELDS TO 14.8×1011 WHILE REDUCING ADVERSE EVENTS (1% VS. 2.3% PRE-UPDATE). HAEMONETICS ALSO SAW IMPROVED YIELDS AND FEWER ADVERSE EVENTS (1% VS. 4.3%), THOUGH ITS OVERALL YIELD REMAINED LOWER (6.3×1011, P<0.05). BOTH MAINTAINED SAFE POST PROCEDURE PLATELET COUNTS (>130000/L). HOWEVER, TRIMA'S PREDICTED YIELDS FOR VERY HIGH COLLECTIONS (>12×1011) SIGNIFICANTLY DIFFERED FROM LAB-DETERMINED YIELDS. TRIMA AND OPTIA PROVIDE BETTER PLATELET COLLECTION EFFICIENCY THAN HAEMONETICS. SOFTWARE UPDATES IM PROVED BOTH TRIMA AND HAEMONETICS' PERFORMANCE AND SAFETY; HOWEVER, TRIMA'S HIGH-YIELD PREDICTIONS NEED REFINING. OPTIMAL SETTINGS, UPDATED SOFTWARE, AND CAREFUL DONOR SELECTION ARE ESSENTIAL FOR MAXIMIZING PLATELET YIELD AND DONOR SAFETY IN RESOURCE-LIMITED AREAS. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.