Timing of hypotensive adverse events in U.S. source plasma donors: Exploratory analysis from the IMPACT trial


      • The largest prospective study to date of timing of hypotensive AEs in plasma donors.
      • None of the analyzed donor characteristics were associated with time to hypotensive AE.
      • However, repeat donors tended to have AEs ~6 min later vs naïve donors (non-significant).
      • No early peak in hypotensive AEs as typically seen in whole blood donation
      • This was unexpected given a similar hypovolemic challenge early during plasmapheresis.


      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.


      Linear regression revealed that repeat donors tended to have AEs ~6 min later than naïve 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).


      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.


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      1. Plasma Protein Therapeutics Association. Total Collections in the U.S. Cited 2022 May 19. Available from 〈–2019.pdf〉.

        • Hartmann J.
        • Ragusa M.J.
        • Burchardt E.R.
        • Manukyan Z.
        • Popovsky M.A.
        • Leitman S.F.
        Personalized collection of plasma from healthy donors: a randomized controlled trial of a novel technology-enabled nomogram.
        Transfusion. 2021; 61: 1789-1798
        • Hartmann J.
        • Ragusa M.J.
        • Popovsky M.A.
        • Leitman S.F.
        Source plasma collection in the United States: toward a more personalized approach.
        Am J Hematol. 2020; 95
        • Strengers P.F.
        • Klein H.G.
        Plasma is a strategic resource.
        Transfusion. 2016; 56: 3133-3137
        • Hartmann J.
        • Klein H.G.
        Supply and demand for plasma-derived medicinal products - a critical reassessment amid the COVID-19 pandemic.
        Transfusion. 2020; 60: 2748-2752
        • Hartmann J.
        Google trends as an early indicator for shortages of intravenous immunoglobulin (IVIG).
        Transfusion. 2020; 60: 1656-1657
        • Philip J.
        • Sarkar R.S.
        • Jain N.
        A single-centre study of vasovagal reaction in blood donors: Influence of age, sex, donation status, weight, total blood volume and volume of blood collected.
        Asian J Transfus Sci. 2014; 8: 43-46
      2. American Red Cross. U.S. Blood Supply Facts. Importance of the Blood Supply. Cited 2022 May 19. Available from 〈〉.

        • Hartmann J.
        • Ragusa M.J.
        • Burchardt E.R.
        • Manukyan Z.
        • Popovsky M.A.
        • Leitman S.F.
        Repeat donation and deferral rates in US source plasma donors: Exploratory analysis from the IMPACT trial.
        Transfusion. 2021; 61: 2849-2854
        • Kamel H.
        • Tomasulo P.
        • Bravo M.
        • Wiltbank T.
        • Cusick R.
        • James R.C.
        • et al.
        Delayed adverse reactions to blood donation.
        Transfusion. 2010; 50: 556-565
      3. Plasma Protein Therapeutics Association. IQPP Donor Fluid Administration Standard. Plasma Protein Therapeutics Association. Cited 2022 May 19. Available from 〈〉.

      4. Plasma Protein Therapeutics Association. IQPP Standard for Recording Donor Adverse Events. Plasma Protein Therapeutics Association. Cited 2022 May 19. Available from 〈〉.

        • Hollander M.
        • Wolfe D.A.
        • Chicken E.
        Nonparametric Statistical Methods. third ed. Wiley, New York2015
      5. Gustafson M. Source Plasma Donor Hemovigilance Activities and Results. Cited 2022 May 19. Available from 〈〉.

        • Schreiber G.B.
        • Becker M.
        • Fransen M.
        • Hershman J.
        • Lenart J.
        • Song G.
        • et al.
        Plasmavigilance-adverse events among US Source plasma donors.
        Transfusion. 2021; 61: 2941-2957
      6. Prospective, randomized, controlled, multicenter clinical trial to demonstrate the safety and effectiveness of the NexSys® PCS Plasma Collection System with the Percent Plasma Nomogram (PPN) Feature. Investigational Plan. Cited 2022 May 19. Available from 〈〉.

        • Newman B.H.
        Management of young blood donors.
        Transfus Med Hemother. 2014; 41: 284-295
        • Seheult J.N.
        • Lund M.E.
        • Yazer M.H.
        • Titlestad K.
        Factors associated with vasovagal reactions in apheresis plasma and whole blood donors: a statistical-epidemiological study in a European donor cohort.
        Blood Res. 2016; 51: 293-296