PMID- 35667962
OWN - NLM
STAT- MEDLINE
DCOM- 20221209
LR  - 20221209
IS  - 1473-0502 (Print)
IS  - 1473-0502 (Linking)
VI  - 61
IP  - 6
DP  - 2022 Dec
TI  - Timing of hypotensive adverse events in U.S. source plasma donors: Exploratory 
      analysis from the IMPACT trial.
PG  - 103470
LID - S1473-0502(22)00144-6 [pii]
LID - 10.1016/j.transci.2022.103470 [doi]
AB  - BACKGROUND AND OBJECTIVES: There is less robust data describing adverse events 
      (AEs) in source plasma donors than in whole blood donors, particularly regarding 
      time to AEs (TAEs). We, therefore, sought to characterize TAE and the influence 
      of donor characteristics in a large-scale clinical trial dataset. MATERIALS AND 
      METHODS: TAE was calculated utilizing data from the IMPACT (IMproving PlasmA 
      CollecTion) trial, with linear regression analyses performed to determine the 
      influence of donor parameters on TAE. RESULTS: Linear regression revealed that 
      repeat donors tended to have AEs ~6 min later than naive donors in the IMPACT 
      trial; however, this was not statistically significant (p = 0.781). Besides this, 
      gender showed greatest difference in TAE; however, no covariates were 
      statistically significant. AE rates were relatively constant throughout the 
      donation process with higher rates beginning 40 min after initiation; no initial 
      peak was observed (first 10-15 min). CONCLUSION: AEs occurred throughout the 
      donation process. None of the analyzed factors could fully explain the difference 
      in the dynamics of AE timing with that of whole blood donation, particularly the 
      missing early peak. Therefore, other factors, e.g., expectation and attitude 
      towards donating plasma and potential events during plasma collection, may 
      explain this difference and should be the focus of future studies.
CI  - Copyright (c) 2022 Elsevier Ltd. All rights reserved.
FAU - Hartmann, Jan
AU  - Hartmann J
AD  - Haemonetics Corporation, Boston, MA, USA. Electronic address: 
      Jan.Hartmann@haemonetics.com.
FAU - Ragusa, Michael J
AU  - Ragusa MJ
AD  - Haemonetics Corporation, Boston, MA, USA. Electronic address: 
      Ragusa@haemonetics.com.
FAU - Manukyan, Zorayr
AU  - Manukyan Z
AD  - ClinStatDevice, Lexington, MA, USA. Electronic address: 
      zorayr@clinstatdevice.com.
FAU - Popovsky, Mark A
AU  - Popovsky MA
AD  - Haemonetics Corporation, Boston, MA, USA. Electronic address: 
      MPopovsky@haemonetics.com.
LA  - eng
PT  - Journal Article
DEP - 20220528
PL  - England
TA  - Transfus Apher Sci
JT  - Transfusion and apheresis science : official journal of the World Apheresis 
      Association : official journal of the European Society for Haemapheresis
JID - 101095653
MH  - Humans
MH  - *Blood Donors
MH  - *Plasma
MH  - Clinical Trials as Topic
OTO - NOTNLM
OT  - Donor health
OT  - Plasma
OT  - Plasma collection
EDAT- 2022/06/07 06:00
MHDA- 2022/12/06 06:00
CRDT- 2022/06/06 22:06
PHST- 2022/02/24 00:00 [received]
PHST- 2022/05/20 00:00 [revised]
PHST- 2022/05/23 00:00 [accepted]
PHST- 2022/06/07 06:00 [pubmed]
PHST- 2022/12/06 06:00 [medline]
PHST- 2022/06/06 22:06 [entrez]
AID - S1473-0502(22)00144-6 [pii]
AID - 10.1016/j.transci.2022.103470 [doi]
PST - ppublish
SO  - Transfus Apher Sci. 2022 Dec;61(6):103470. doi: 10.1016/j.transci.2022.103470. 
      Epub 2022 May 28.