PMID- 34390267
OWN - NLM
STAT- MEDLINE
DCOM- 20211104
LR  - 20220731
IS  - 1537-2995 (Electronic)
IS  - 0041-1132 (Print)
IS  - 0041-1132 (Linking)
VI  - 61
IP  - 10
DP  - 2021 Oct
TI  - Plasmavigilance-Adverse events among US Source plasma donors.
PG  - 2941-2957
LID - 10.1111/trf.16612 [doi]
AB  - BACKGROUND: Source plasma (SP) is the primary starting material for 87% of 
      plasma-derived medicinal products globally. Plasmavigilance is a program designed 
      to collect, analyze, and monitor donor adverse events (AEs) across the SP 
      collection industry. Donor retention depends on donors having a safe and 
      satisfactory experience. This study analyzes AE rates and SP donor 
      characteristics that may be predictors of an AE. STUDY DESIGN AND METHODS: 
      Donation data for 1.1 million donors making 12,183,182 SP donations over a 
      4-month period were analyzed. This represented approximately 72% of the donations 
      collected by the U.S. plasma industry. The Standard for Recording Donor Adverse 
      Events was used for AE definitions and classifications. RESULTS: The overall AE 
      rate was 15.85/10(4) donations. The two AEs with the highest rates were 
      Hypotensive and Phlebotomy events (8.32 and 5.91/10(4) donations, respectively). 
      Females had higher overall AE rates than males (25.76 vs. 9.85/10(4) donations), 
      and first-time donors had higher overall AE rates than repeat donors (136.66 vs. 
      12.37/10(4) donations). Weight, body mass index, age, and pre-donation estimated 
      blood volume also were predictors of AE. DISCUSSION: SP donors have low AE rates 
      with 90% being events classified as Hypotensive or Phlebotomy. Special attention 
      and mitigation strategies should be directed to donors who are young, lightweight 
      (between 100 and 124 pounds), female, or first-time donors to further reduce the 
      incidence of AE, continue to ensure the donor has a safe experience, and 
      facilitate donor retention.
CI  - (c) 2021 Plasma Protein Therapeutics Association. Transfusion published by Wiley 
      Periodicals LLC on behalf of AABB.
FAU - Schreiber, George B
AU  - Schreiber GB
AUID- ORCID: 0000-0003-1602-5248
AD  - Plasma Protein Therapeutics Association, Annapolis, Maryland, USA.
FAU - Becker, Mark
AU  - Becker M
AD  - Biomat USA, Inc, Seattle, Washington, USA.
FAU - Fransen, Michelle
AU  - Fransen M
AD  - Plasma Protein Therapeutics Association, Annapolis, Maryland, USA.
FAU - Hershman, Janet
AU  - Hershman J
AD  - Takeda/BioLife Plasma Services LP, Bannockburn, Illinois, USA.
FAU - Lenart, James
AU  - Lenart J
AD  - Takeda/BioLife Plasma Services LP, Bannockburn, Illinois, USA.
FAU - Song, Guang
AU  - Song G
AD  - FEI Systems, Columbia, Maryland, USA.
FAU - Simon, Toby
AU  - Simon T
AD  - CSL Plasma, Boca Raton, Florida, USA.
LA  - eng
PT  - Journal Article
DEP - 20210814
PL  - United States
TA  - Transfusion
JT  - Transfusion
JID - 0417360
SB  - IM
CIN - Transfusion. 2021 Oct;61(10):2803-2805. PMID: 34605562
MH  - Adult
MH  - Age Factors
MH  - *Blood Donors
MH  - Blood Specimen Collection/*adverse effects
MH  - Blood Volume
MH  - Female
MH  - Humans
MH  - Hypotension/etiology
MH  - Male
MH  - Phlebotomy/adverse effects
MH  - *Plasma/chemistry
MH  - Risk Factors
MH  - Sex Factors
MH  - United States
PMC - PMC9291118
OTO - NOTNLM
OT  - adverse events
OT  - donation frequency
OT  - plasmavigilance
OT  - source plasma
COIS- GBS and MF are the employees of the Plasma Protein Therapeutics Association. MB 
      is an employee of Biomat USA, Inc. JH and JL are the employees of Takeda/BioLife 
      Plasma Services LP. GS is an employee of FEI Systems. And TS is an employee of 
      CSL Plasma.
EDAT- 2021/08/15 06:00
MHDA- 2021/11/05 06:00
PMCR- 2022/07/18
CRDT- 2021/08/14 08:36
PHST- 2021/07/19 00:00 [revised]
PHST- 2021/04/01 00:00 [received]
PHST- 2021/07/19 00:00 [accepted]
PHST- 2021/08/15 06:00 [pubmed]
PHST- 2021/11/05 06:00 [medline]
PHST- 2021/08/14 08:36 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - TRF16612 [pii]
AID - 10.1111/trf.16612 [doi]
PST - ppublish
SO  - Transfusion. 2021 Oct;61(10):2941-2957. doi: 10.1111/trf.16612. Epub 2021 Aug 14.