PMID- 37969863
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231117
IS  - 1660-3796 (Print)
IS  - 1660-3818 (Electronic)
IS  - 1660-3796 (Linking)
VI  - 49
IP  - 5
DP  - 2022 Sep
TI  - Safety of Plasmapheresis in Donors with Low IgG Levels: Results of a Prospective, 
      Controlled Multicentre Study.
PG  - 271-279
LID - 10.1159/000522528 [doi]
AB  - BACKGROUND AND OBJECTIVES: Although plasmapheresis is generally considered safe, 
      there are still concerns about the long-term effects of plasma donation on 
      immunoglobulin G (IgG) levels. The aim of the present study was to investigate if 
      there is a need to permanently defer donors who donated three times with an IgG 
      level below 6.0 g/L. STUDY DESIGN AND METHODS: From September 2007 to December 
      2017, adverse events (AEs) including infections were analysed from data of a 
      prospective, controlled multicentre study of healthy volunteer donors, 
      participating in an individualized plasmapheresis programme stratified by initial 
      IgG level and body weight (individualized arm) or in standard plasmapheresis 
      according to national guidelines (control arm). IgG was monitored at every fifth 
      donation, and donors with IgG levels below the threshold were identified and 
      followed up for possible AEs. RESULTS: In total, 97,540 donations in 1,462 donors 
      in the control arm and 1,491,223 donations in 14,281 donors in the individualized 
      arm were included. Donation-based incidences of at least severe AEs and any 
      infections were 0.019% and 0.192% in the control arm, and 0.014% and 0.153% in 
      the individualized arm. Three or more IgG-measurements below the threshold 
      occurred in 38.2% of control arm donors and 20.9% of individualized arm donors. 
      There were no increased incidence rates of at least severe AEs or any infections 
      in donors with >/=3 IgG-measurements below the threshold in either donor's arm. 
      CONCLUSIONS: Our data show no signs of compromised donor safety in donors with >/=3 
      IgG-measurements below the threshold, indicating that plasmapheresis is feasible 
      and safe in these donors.
CI  - Copyright (c) 2022 by The Author(s). Published by S. Karger AG, Basel.
FAU - Moog, Rainer
AU  - Moog R
AD  - Octapharma Plasma GmbH, Langenfeld, Germany.
FAU - Laitinen, Teija
AU  - Laitinen T
AD  - Octapharma Plasma GmbH, Langenfeld, Germany.
FAU - Taborski, Uwe
AU  - Taborski U
AD  - Octapharma Plasma GmbH, Langenfeld, Germany.
LA  - eng
PT  - Journal Article
DEP - 20220414
PL  - Switzerland
TA  - Transfus Med Hemother
JT  - Transfusion medicine and hemotherapy : offizielles Organ der Deutschen 
      Gesellschaft fur Transfusionsmedizin und Immunhamatologie
JID - 101176417
PMC - PMC10642530
OTO - NOTNLM
OT  - Adverse events
OT  - Donor plasmapheresis
OT  - Donor vigilance
OT  - Immunoglobulin G level
COIS- The authors are employees of Octapharma Plasma GmbH, Langenfeld, Germany.
EDAT- 2022/04/14 00:00
MHDA- 2022/04/14 00:01
PMCR- 2022/04/14
CRDT- 2023/11/16 04:25
PHST- 2021/07/22 00:00 [received]
PHST- 2022/02/06 00:00 [accepted]
PHST- 2022/04/14 00:01 [medline]
PHST- 2022/04/14 00:00 [pubmed]
PHST- 2023/11/16 04:25 [entrez]
PHST- 2022/04/14 00:00 [pmc-release]
AID - tmh-0049-0271 [pii]
AID - 10.1159/000522528 [doi]
PST - epublish
SO  - Transfus Med Hemother. 2022 Apr 14;49(5):271-279. doi: 10.1159/000522528. 
      eCollection 2022 Sep.