Extended storage of platelet-rich plasma-prepared platelet concentrates in plasma or Plasmalyte

Abstract

Background: Using bacterial detection or pathogen reduction, extended platelet (PLT) storage may be licensed if PLT viability is maintained. The Food and Drug Administration (FDA)'s poststorage PLT acceptance guidelines are that autologous stored PLT recoveries and survivals should be 66 and 58% or greater, respectively, of each donor's fresh PLT data.

Study design and methods: Nonleukoreduced PLT concentrates were prepared from whole blood donations. Autologous PLT concentrates from 62 subjects were stored in 100% plasma (n=44) or 20% plasma/80% Plasmalyte (n=18), an acetate-based, non-glucose-containing crystalloid solution previously used for PLT storage. Fresh PLTs were obtained on the day the donor's stored PLTs were to be transfused. The fresh and stored PLTs were alternately radiolabeled with either (51) chromium or (111) indium, and in vitro measurements were performed on the stored PLTs.

Results: The FDA's PLT recovery criteria were met for 7 days of plasma storage, but PLT survivals maintained viability for only 6 days. Plasmalyte-stored PLTs did not meet either acceptance criteria after 6 days of storage. After 7 days of storage, PLT recoveries averaged 43±4 and 30±4% and survivals 4.1±0.4 and 2.0±0.2 days for plasma- and Plasmalyte-stored PLTs, respectively (p=0.03 for recoveries and p<0.001 for survivals). Poststorage PLT recoveries correlated with the commonly used in vitro PLT quality measurements of hypotonic shock response and annexin V binding, while survivals correlated with extent of shape change, morphology score, and pH.

Conclusion: There is a progressive decrease in recoveries and survivals of plasma-stored PLTs over time. PLT viability is better maintained in plasma than Plasmalyte.

Figure 1. Autologous Radiolabeled Platelet Recoveries And Survivals Over Storage Time

1A. Platelet Recoveries Versus Storage Time. 1B. Platelet Survivals Versus Storage Time. The relationship between platelet recoveries and survivals and storage time is shown for plasma stored platelets in circles (•) and for Plasmalyte stored platelets in triangles (▲). Data are given as the average ±1 S.E. The regression line for the plasma stored platelet recoveries has a slope of -6.5 (r²=0.29, and p<0.001) and for platelet survivals has a slope of -1.0 (r²=0.43, and p<0.001). In contrast, there is not a statistically significant relationship between storage time for either platelet recoveries or survivals for the Plasmalyte stored platelets.

Figure 1. Autologous Radiolabeled Platelet Recoveries And Survivals Over Storage Time

1A. Platelet Recoveries Versus Storage Time. 1B. Platelet Survivals Versus Storage Time. The relationship between platelet recoveries and survivals and storage time is shown for plasma stored platelets in circles (•) and for Plasmalyte stored platelets in triangles (▲). Data are given as the average ±1 S.E. The regression line for the plasma stored platelet recoveries has a slope of -6.5 (r²=0.29, and p<0.001) and for platelet survivals has a slope of -1.0 (r²=0.43, and p<0.001). In contrast, there is not a statistically significant relationship between storage time for either platelet recoveries or survivals for the Plasmalyte stored platelets.

Figure 2. Stored Platelet Recoveries And Survivals As A Percentage Of The Same Donors’ Fresh Platelet Recoveries And Survivals

2A. Stored Platelet Recoveries As A Percentage Of Fresh Over Storage Time. 2B. Stored Platelet Survivals As A Percentage Of Fresh Over Storage Time. Plasma data are shown as circles (•) and Plasmalyte data as triangles (▲). The data are given as the average ±1 S.E. of the donors’ stored platelet recoveries or survivals as a percentage of the same donors’ fresh platelet recoveries or survivals, respectively. In Figure 2A, the horizontal dashed line is stored recoveries at 66% of fresh, and, in Figure 2B, the horizontal lines are stored survivals of either 58% or 50% of fresh (the FDA and Dr. Murphy's acceptance criteria, respectively). The regression line for the plasma stored platelet recoveries as a percentage of fresh has a slope of -9.8, (r²=0.44 and p<0.001), and the regression line for the plasma stored platelet survivals as a percentage of fresh has a slope of -12.8, (r²=0.44 and p < 0.001). For the Plasmalyte stored platelets, there is no relationship between storage time and the ratios of stored to fresh platelet recoveries or survivals.

Figure 2. Stored Platelet Recoveries And Survivals As A Percentage Of The Same Donors’ Fresh Platelet Recoveries And Survivals

2A. Stored Platelet Recoveries As A Percentage Of Fresh Over Storage Time. 2B. Stored Platelet Survivals As A Percentage Of Fresh Over Storage Time. Plasma data are shown as circles (•) and Plasmalyte data as triangles (▲). The data are given as the average ±1 S.E. of the donors’ stored platelet recoveries or survivals as a percentage of the same donors’ fresh platelet recoveries or survivals, respectively. In Figure 2A, the horizontal dashed line is stored recoveries at 66% of fresh, and, in Figure 2B, the horizontal lines are stored survivals of either 58% or 50% of fresh (the FDA and Dr. Murphy's acceptance criteria, respectively). The regression line for the plasma stored platelet recoveries as a percentage of fresh has a slope of -9.8, (r²=0.44 and p<0.001), and the regression line for the plasma stored platelet survivals as a percentage of fresh has a slope of -12.8, (r²=0.44 and p < 0.001). For the Plasmalyte stored platelets, there is no relationship between storage time and the ratios of stored to fresh platelet recoveries or survivals.

Figure 3. Comparison of Each Donor's Fresh Versus Their Stored Autologous Platelet Recovery

3A. Plasma Stored Platelet Recovery Compared To The Same Donor's Fresh Platelet Recovery. 3B. Plasmalyte Stored Platelet Recovery Compared To The Same Donor's Fresh Platelet Recovery. Five-day storage data are plotted as (▷), 6 day data as (•), 7 day data as (□), and 8 day data as (▲). The regressions for the plasma and Plasmalyte stored data are summarized by slopes of 0.75 and 0.54 (r²=0.39 and 0.27, and p<0.001 and 0.03 respectively).

Figure 3. Comparison of Each Donor's Fresh Versus Their Stored Autologous Platelet Recovery

3A. Plasma Stored Platelet Recovery Compared To The Same Donor's Fresh Platelet Recovery. 3B. Plasmalyte Stored Platelet Recovery Compared To The Same Donor's Fresh Platelet Recovery. Five-day storage data are plotted as (▷), 6 day data as (•), 7 day data as (□), and 8 day data as (▲). The regressions for the plasma and Plasmalyte stored data are summarized by slopes of 0.75 and 0.54 (r²=0.39 and 0.27, and p<0.001 and 0.03 respectively).

Figure 4. Comparison of Each Donor's Fresh Versus Their Stored Autologous Platelet Survival

4A. Plasma Stored Platelet Survival Compared To The Same Donor's Fresh Platelet Survival. 4B. Plasmalyte Stored Platelet Survival Compared To The Same Donor's Fresh Platelet Survival. Five-day storage data are plotted as (▷), 6 day data as (•), 7 day data as (□), and 8 day data as (▲). The regression line for the plasma stored data has a slope of 0.36 (r²=0.11 and p=0.03). In contrast, there is no relationship between each donor's Plasmalyte stored platelet survival data and their corresponding fresh platelet survival data.

Figure 4. Comparison of Each Donor's Fresh Versus Their Stored Autologous Platelet Survival

4A. Plasma Stored Platelet Survival Compared To The Same Donor's Fresh Platelet Survival. 4B. Plasmalyte Stored Platelet Survival Compared To The Same Donor's Fresh Platelet Survival. Five-day storage data are plotted as (▷), 6 day data as (•), 7 day data as (□), and 8 day data as (▲). The regression line for the plasma stored data has a slope of 0.36 (r²=0.11 and p=0.03). In contrast, there is no relationship between each donor's Plasmalyte stored platelet survival data and their corresponding fresh platelet survival data.

Figure 5. Associations Between Post-Storage In Vitro And In Vivo Platelet Measurements

5A. Post-Storage In Vitro Measurements Versus Stored Platelet Recoveries. Plots of post storage platelet recovery versus individual in vitro measurements. Statistics for the regression lines: ESC (slope = 1.3, r²=0.25 and p = 0.001); HSR (slope = 0.37, r²=0.28 and p=0.001); and Annexin V binding (slope = -0.60, r²=0.26 and p=0.001). Plasma data are shown by closed circles (•), and Plasmalyte data as closed triangles (▲). 5B. Post-Storage In Vitro Measurements Versus Stored Platelet Survivals. Plots of post storage platelet survival versus individual in vitro measurements. Statistics for the regression lines: ESC (slope = 0.26, r²= 0.60 and p < 0.001); pH 37ºC (slope = 3.6, r²= 0.22 and p = 0.001); and morphology score (slope = 0.02, r²= 0.30 and p = 0.001). Plasma data are shown by closed circles (•) and Plasmalyte data as closed triangles (▲).

Figure 5. Associations Between Post-Storage In Vitro And In Vivo Platelet Measurements

5A. Post-Storage In Vitro Measurements Versus Stored Platelet Recoveries. Plots of post storage platelet recovery versus individual in vitro measurements. Statistics for the regression lines: ESC (slope = 1.3, r²=0.25 and p = 0.001); HSR (slope = 0.37, r²=0.28 and p=0.001); and Annexin V binding (slope = -0.60, r²=0.26 and p=0.001). Plasma data are shown by closed circles (•), and Plasmalyte data as closed triangles (▲). 5B. Post-Storage In Vitro Measurements Versus Stored Platelet Survivals. Plots of post storage platelet survival versus individual in vitro measurements. Statistics for the regression lines: ESC (slope = 0.26, r²= 0.60 and p < 0.001); pH 37ºC (slope = 3.6, r²= 0.22 and p = 0.001); and morphology score (slope = 0.02, r²= 0.30 and p = 0.001). Plasma data are shown by closed circles (•) and Plasmalyte data as closed triangles (▲).