Plasmavigilance—Adverse events among US Source plasma donors

Background Plasma contains many important proteins of therapeutic interest including albumin, clotting factors, and antibodies. Source plasma (SP) is in great demand particularly due to a shortage of immunoglobulin. To better understand how to increase supply, we examined SP donor deferrals for the previous 3 years. Study design This is a description of donor deferrals at 255 plasma donation centers in the United States for April 1, 2017 to March 31, 2020. Results A total of 4 587 923 events were evaluated for the 3‐year period 2017‐2020. There were 873 227 deferrals analyzed for 2017‐2018, 1 765 582 in 2018‐2019, and 1 949 114 for 2019‐2020. The most common deferral each year was for unacceptable blood pressure (BP) or pulse which comprised 27.9%, 28.2%, and 28.3% of deferrals in 2017‐2018, 2018‐2019, and 2019‐2020, respectively. The second most common cause of deferral was for unacceptable hematocrit which comprised 14.1% of deferrals in 2017‐2018, and 16.0% in 2018‐2019 and 2019‐2020. The majority of these deferred donors had low hematocrits and were predominately (~80%) female. Deferral for unacceptable total protein comprised a smaller percentage (~4%) of deferrals. Discussion Most donor deferrals were due to unacceptable screening results, particularly high BP, elevated pulse, low protein, and low hematocrit. Although rates of deferrals in other categories have been slightly increasing over time, they comprise a small percentage. Donor education regarding healthy lifestyle choices may improve overall donor health, decrease deferrals, and increase SP supply.

Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 98%

“…Schreiber et al recently analyzed 1.1 million SP donors that made 12 183 182 donations over a 4‐month period 23 . They found that the DAE rate was 15.85 per 10 000 donations 23 .…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

Source plasma deferral trends: A 3‐year analysis of 255 centers in the United States

Schmidt¹,

MacKercher²,

Youngling³

et al. 2021

Impact of saline infusion and citrate infusion rate during donor plasmapheresis

Evers

Schreiber

Taborski

2022

Self Cite

The purpose of our research was to evaluate the effects of saline infusion to counteract incidents of severe hypotension during donor plasmapheresis (DP; synonym with plasma donation), and on immunoglobulin G (IgG) content in collected plasma, and on donor hematological values. It examines the clearance (Cl) of IgG during DP without saline to calculate the distribution of citrate and citrate infusion rate (CIR) during DP. It is based on three studies: an observation of saline infusion in donors with severe drops in blood pressure at DP, and two crossover trials of 32 repeat plasma donors each on saline infusion during DP. We observed 50 cases with a significant drop of mean systolic blood pressure ≤90 mm Hg in 1 year, predominantly in young, female first‐time donors. In trial 1, there was a reduction of IgG concentration in collected plasma related to the average IgG serum concentration without saline to 85.5% vs to 80.5% with saline (P < .001). In trial 2, there was an important 11%‐12% increase of the donor hematological values without saline during DP. An average of 84.6% of citrate was removed in retained plasma; our calculated minimal CIR of 0.16 ± 0.17 mg/kg/min was confirmed by other empirical studies. Our research has led to significant improvements in the practice of DP: (a) Saline should be infused at DP as clinically indicated in agreement with the donor. (b) Young, female first‐time donors require special care. (c) The long‐time effects of minimal amounts of citrate on bone metabolism are improbable.

Prospective, open‐label, multicenter clinical study to assess the performance of a new donation system for the collection of source plasma

Mason

Dawson²,

Rhodes

et al. 2023

Background: Safe, efficient, and reliable innovations among donation systems are needed to meet the growing global demand for source plasma. This study assessed the ability of a new donation system to collect appropriate product weights based on the US Food and Drug Administration nomogram for source plasma collections. Procedure duration and safety endpoints were also collected.Study Design and Methods: The Rika Plasma Donation System (Terumo BCT, Inc., Lakewood, CO) was evaluated in a prospective, open-label, multicenter study. Healthy adults meeting FDA and Plasma Protein Therapeutics Association requirements for source plasma donor eligibility were consented and enrolled in the study resulting in 124 evaluable products. Results: The target product collection weights (ie, including plasma and anticoagulant) by participant weight category were: 705 g (110-149 lbs), 845 g (150-174 lbs), and 900 g (≥175 lbs). The mean reported product collection weights by participant weight category were 705.0 ± 0.00, 845.0 ± 0.20, and 899.9 ± 0.31 g, respectively. The mean overall procedure time was 31.5 ± 5.41 minutes. The mean procedure times by participant weight category were 25.6 ± 3.13, 30.5 ± 4.45, and 33.7 ± 4.80 minutes, respectively. Procedure-emergent adverse events (PEAEs) occurred in five participants. All PEAEs were consistent with known risks for apheresis donation, and none were related to the donation system.Conclusions: The new donation system collected the target product collection weight in 100% of evaluable products. The mean procedure collection time was 31.5 minutes. The system is a new efficient platform that consistently collects the appropriate weight of the source plasma.