Safety and performance of the S pectra O ptia apheresis system for white blood cell depletion in patients with elevated white blood cell counts

Autor: Pamela Lopert, Sohair Abdelrahman, Christopher A. Graybill, Jack Rhodes, Daan Dierickx, Richard Schäfer, Marienn Reti, Depei Wu, Yu Hu, Fen Huang, Jianda Hu, Pengcheng He, Ligen Liu, Ming Li, Xuejun Zhang, Jerry Bill
Rok vydání: 2023
Předmět:
Zdroj: Journal of Clinical Apheresis.
ISSN: 1098-1101
0733-2459
DOI: 10.1002/jca.22038
Popis: BACKGROUND: For the past 30 years, white blood cell depletion (WBCD) or leukocytapheresis has been conducted to rapidly reduce excessive circulating white blood cell (WBC) concentrations in patients at risk for or with symptoms of leukostasis due to hyperleukocytosis. The goal of leukocytapheresis is to prevent or treat acute complications from leukostasis, thereby enabling patients to receive potentially curative chemotherapy. METHODS: This report details the results from a retrospective and a prospective clinical study conducted in the European Union and the People's Republic of China, which assessed the use of the Spectra Optia Apheresis System for leukocytapheresis in patients with hyperleukocytosis. The primary objective of both studies was to the assess the safety and performance of the WBCD procedure in patients with elevated WBC counts. RESULTS: Data were collected from 72 participants completing 87 WBCD procedures. The mean percent change in participant WBC counts post-procedure was 50.3 ± 21.2% and the collection efficiency (CE1) of the WBCD procedures was 53.7 ± 19.8%. Sixty-one participants (95.3%) experienced a total of 279 adverse events (AEs) with the majority of the AEs related to post-procedure changes in laboratory values, which is an anticipated AE in this patient population. CONCLUSION: The data collected within these studies indicate that the WBCD procedure is safe and well tolerated in patients with hyperleukocytosis as evaluated by percent decrease in WBC count, CE1, and AE incidence. ispartof: JOURNAL OF CLINICAL APHERESIS vol:38 issue:4 pages:396-405 ispartof: location:United States status: accepted
Databáze: OpenAIRE
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