PMID- 36102144
OWN - NLM
STAT- MEDLINE
DCOM- 20221202
LR  - 20230413
IS  - 1098-1101 (Electronic)
IS  - 0733-2459 (Print)
IS  - 0733-2459 (Linking)
VI  - 37
IP  - 6
DP  - 2022 Dec
TI  - The safety and performance of the Spectra Optia apheresis system platelet 
      depletion protocol in patients with elevated platelet counts.
PG  - 544-552
LID - 10.1002/jca.22009 [doi]
AB  - BACKGROUND: Thrombocytosis is a presenting and progressive clinical feature found 
      in multiple disease states. It is characterized by high platelet (PLT) counts 
      (>450 x 10(9) /L) and can lead to thrombohemorrhagic events. Thrombocytapheresis 
      or platelet depletion (PLTD) can be performed in acutely symptomatic patients 
      suffering from thrombocytosis and may reduce or prevent acute serious 
      complications associated with thrombocythemia thereby enabling patients to 
      receive potentially curative high-dose chemotherapy. METHODS: This report details 
      the results from 2 clinical studies, one conducted in the European Union (EU) and 
      one in the People's Republic of China, assessing the PLTD procedure on the 
      Spectra Optia Apheresis System. The primary objective of both studies was to 
      assess the safety and performance of the PLTD procedure in patients with elevated 
      PLT counts. RESULTS: Data were collected from 56 participants completing 64 PLTD 
      procedures. The mean percent change in PLT count and collection efficiency (CE1) 
      was 55.1% and 68.5%, respectively. In the EU study, 6 participants experienced a 
      total of 9 adverse events (AEs) and in the China study, 44 participants reported 
      a total of 212 AEs. In both studies, the majority of AEs reported were Grade 2 or 
      lower and no serious AEs, unanticipated adverse device effects, or AEs leading to 
      death were reported. CONCLUSIONS: The data collected within these studies 
      indicate that the PLTD procedure is well tolerated and effective at reducing 
      circulating PLTs in patients suffering from thrombocytosis as evaluated by a 
      percent decrease in PLT count, CE1, and AE incidence.
CI  - (c) 2022 Terumo BCT Ltd. Inc. Journal of Clinical Apheresis published by Wiley 
      Periodicals LLC.
FAU - Lopert, Pamela
AU  - Lopert P
AUID- ORCID: 0000-0002-6625-7832
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Abdelrahman, Sohair
AU  - Abdelrahman S
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Graybill, Christopher A
AU  - Graybill CA
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Rhodes, Jack
AU  - Rhodes J
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
FAU - Sorensen, Betina
AU  - Sorensen B
AD  - Aarhus University Hospital Skejby, Aarhus, Denmark.
FAU - Li, Ming
AU  - Li M
AD  - The Second People's Hospital of Shenzhen, Shenzhen, China.
FAU - Hu, Yu
AU  - Hu Y
AD  - Wuhan Union Hospital, Wuhan, China.
FAU - Wu, Depei
AU  - Wu D
AD  - The First Affiliated Hospital of Soochow University, Suzhou, China.
FAU - Liu, Ligen
AU  - Liu L
AD  - Tongren Hospital Shanghai Jiaotong University School of Medicine, Shanghai, 
      China.
FAU - He, Pengcheng
AU  - He P
AD  - The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
FAU - Zhang, Xuejun
AU  - Zhang X
AD  - The Second Hospital of Hebei Medical University, Xi'an, China.
FAU - Huang, Fen
AU  - Huang F
AD  - Nanfang Hospital, Guangzhou, China.
FAU - Hu, Jianda
AU  - Hu J
AD  - Fujian Medical University Union Hospital, Fujian, China.
FAU - Bill, Jerry
AU  - Bill J
AD  - Terumo BCT, Inc., Lakewood, Colorado, USA.
LA  - eng
GR  - Terumo BCT/
PT  - Journal Article
DEP - 20220914
PL  - United States
TA  - J Clin Apher
JT  - Journal of clinical apheresis
JID - 8216305
SB  - IM
MH  - Humans
MH  - Platelet Count
MH  - *Thrombocytosis/therapy
MH  - Plateletpheresis/methods
MH  - China
PMC - PMC10087614
OTO - NOTNLM
OT  - collection efficiency
OT  - essential thrombocythemia
OT  - myeloproliferative neoplasm
OT  - platelets
OT  - therapeutic apheresis
OT  - thrombocytapheresis
OT  - thrombocytosis
COIS- Pamela Lopert, Sohair Abdelrahman, Christopher A. Graybill, Jack Rhodes, and 
      Jerry Bill were, at the time of the studies, employees of Terumo BCT. The 
      institutions that conducted these clinical trials received support from Terumo 
      BCT.
EDAT- 2022/09/15 06:00
MHDA- 2022/12/03 06:00
PMCR- 2023/04/11
CRDT- 2022/09/14 04:32
PHST- 2022/07/11 00:00 [revised]
PHST- 2022/03/23 00:00 [received]
PHST- 2022/08/18 00:00 [accepted]
PHST- 2022/09/15 06:00 [pubmed]
PHST- 2022/12/03 06:00 [medline]
PHST- 2022/09/14 04:32 [entrez]
PHST- 2023/04/11 00:00 [pmc-release]
AID - JCA22009 [pii]
AID - 10.1002/jca.22009 [doi]
PST - ppublish
SO  - J Clin Apher. 2022 Dec;37(6):544-552. doi: 10.1002/jca.22009. Epub 2022 Sep 14.