|Ahead of print
|Effect of plateletpheresis on donor variables and platelet yield using three different cell separators: Experience from tertiary care hospital
Sarita Sharma1, Sunita Bundas1, Nippun Prinja2, Amit Sharma1, Rachna Narain1
1 Department of Immunohematology and Transfusion Medicine, SMS Medical College and Hospital, Jaipur, Rajasthan, India
2 Department of Transfusion Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
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|Date of Submission||26-Jul-2021|
|Date of Decision||25-Sep-2021|
|Date of Acceptance||19-Dec-2021|
|Date of Web Publication||04-Jun-2022|
| Abstract|| |
INTRODUCTION: Platelet collection by apheresis is common nowadays. Many cell separators are available in the market for the same. This study was conducted to study the effect of various donor factors on platelet yield and the effect of different cell separator variables on platelet yield.
MATERIALS AND METHODS: This cross-sectional study was done on 600 healthy apheresis platelet donors from April 2016 to March 2017 using three different cell separators. Donor variables, pre, and post-plateletpheresis hematological parameters, machine variables, platelet yield were observed.
RESULTS: Postprocedural decline in hematological variables was seen. A positive correlation was seen with pre-apheresis platelet count, blood volume processed, and product volume. Product volume obtained was highest with COM. TEC. Mean platelet yield was maximally seen in Amicus.
CONCLUSION: Main predictors of platelet yield are platelet count and volume processed. Donors with lower hemoglobin had better yields. Higher platelet counts lead to better product hence platelet increment in the patient.
Keywords: Cell separator, donor variables, hematological parameters, machine variables, platelet yield
|How to cite this URL:|
Sharma S, Bundas S, Prinja N, Sharma A, Narain R. Effect of plateletpheresis on donor variables and platelet yield using three different cell separators: Experience from tertiary care hospital. Asian J Transfus Sci [Epub ahead of print] [cited 2022 Dec 4]. Available from: https://www.ajts.org/preprintarticle.asp?id=345966
| Introduction|| |
Platelets play an essential role in hemostasis. Platelet function and utilization in various bleeding disorders have been studied widely. The first fruitful attempt to raise the platelet count in thrombocytopenia patients was done by Duke in 1910 by transfusing whole blood. Since then, continuous improvement in component preparation is being done to separate platelets from whole blood. Platelets are available in the form of random donor platelet cells and single donor platelet (SDPC).
Random donor platelets are prepared from whole blood by Buffy coat method or by platelet-rich plasma (PRP) method within 6 h of blood collection. SDPC product is prepared with an automated cell separator. Principle of cell separator is either intermittent flow centrifugation (IFC) (Hemonetics MCS+) or continuous flow centrifugation (CFC) (e.g. Amicus and COM. TEC). Platelets obtained by an apheresis procedure provide the equivalent of six to eight random donor platelets, thus decreasing donor exposure for a patient.
This study was done to observe the effect of plateletpheresis on preapheresis and postapheresis hematological values (hemoglobin [Hb], hematocrit [Hct], and platelet count) of donor population and to study the effect of various donor factors (Hb, Hct, platelet count), operational variables (blood volume processed and duration of procedure), and product variables on platelet yield. Apart from that, operational and product variables comparison among cell separators was another objective of this study.
To the best of our knowledge, no similar study from our region has been conducted on such a large study population.
| Materials and Methods|| |
A descriptive type of Cross-sectional study was done in the department of Immunohaematology and Transfusion Medicine at a tertiary care hospital in northwestern India from April 2016 to March 2017. Six hundred healthy plateletpheresis (SDPC) donors were selected according to departmental standard operating procedures (SOPs) prepared as per directorate general health services transfusion medicine technical manual 2003.
Our study was approved by the Institutional Ethical Committee. All those donors who were willing to participate in the study and gave written consent for the same were included in the study. Unfit donors, procedures interrupted due to small veins, kit leakage during priming, incomplete procedures, and donors who did not give consent were excluded from the study.
Preprocedural work-up such as donor screening, blood grouping, and screening for transfusion-transmitted infections was done as per departmental SOPs. The donor was counseled, and queries were answered. Continuous monitoring of the procedure was done to assure an uneventful procedure. Two hundred procedures each were performed on three different cell separators. The selection of donors on the cell separator was subject to the availability of a particular cell separator at the time of the procedure. Single-needle (SN) system was used in all the procedures. Cell separators used were Fresenius separator (COM. TEC), Fenwal Amicus separator (Baxter Healthcare Corporation, Deerfield, IL, USA), Hemonetics MCS + separator (Hemonetics Corporation, Braintree, Massachusetts, USA). COM. TEC and Amicus cell separators work on the principle of CFC, whereas Hemonetics MCS + on IFC. In the case of Hemonetics, kits used were one with leukoreduction filters. We used S5 L SN plateletpheresis kits in COM. TEC and 4R2312 kits in Amicus.
Relevant data such as donor weight, height, age, gender, pre-procedural Hb, Hct, and platelet count were entered. Processed blood volume to attain the target platelet yield (≥3 × 10 11) was calculated by all cell separators. Machine variables such as blood volume processed, product volume obtained, and duration of the procedure were recorded after the procedure. Donor's blood sample was collected in Ethylenediaminetetraacetic acid vial after 30 min of procedure and platelet count, Hb, and Hct were noted. Two ml sample from the diversion pouch of the product bag was obtained in a plain vial after one hour without being placed in platelet agitator and analyzed for platelet count. Blood counts were analyzed by a calibrated automated analyzer (Sysmex XT 2000i). Platelet yield was noted for each procedure and evaluated concerning donor and machine variables. Platelet yield was calculated as:
Platelet yield = Product volume (ml) × Product count (platelet/μl) × Conversion factor (1000)
All data obtained were entered, segregated, and tabulated in micro excel software as per mentioned variables. Statistical analysis was done using the SPSS, version 21 for Windows statistical software package (SPSS inc., Chicago, IL, USA). Qualitative data was demonstrated in the form of percentages and proportions. The significance of the difference was concluded by the Chi-square test. Quantitative data was demonstrated in the form of mean ± standard deviation. The significance of the difference was concluded by paired t-test. Probability was considered significant if P < 0.05. A correlation study using regression analysis was done to assess the association between parameters.
| Observations and Results|| |
The mean age of donors in our study was 28 (19–47) years [Table 1]. Maximum donors were of the 19–30 age group. The mean body weight of donors in our study population was 73.4 kg, with maximum donors weighing from 70 to 79 kg [Table 1]. The donor height of our study population was 160–188 cm with the mean height of donors being observed 173.53 ± 4.22 cm [Table 1]. Demographic variables of donors were compared on all three cell separators with mean height showing a statistical significance between 3 cell separators using analysis of variance [Table 2].
The postprocedural decline in donor Hb, Hct, and platelet counts was seen which was statistically significant. Multivariate analysis of variance was used to study this [Table 3]. The decrease in Hb and Hct with the Amicus was greater than the COM. TEC and Hemonetics MCS + (P < 0.001). Postprocedural reduction in platelet counts was maximally seen in COM. TEC (P < 0.001). The mean loss of Hb, Hct, and platelet is 5.61 ± 2.44, 3.79 ± 1.48, and 27.08 ± 6.05, respectively [Table 4].
Higher blood volume processed was seen in Amicus than COM. TEC and Hemonetics MCS +. Product volume obtained was higher with COM. TEC followed by Amicus and Hemonetics MCS +. Duration of procedure was observed maximum for COM. TEC (56.91 ± 8.42 min) and minimum (50.69 ± 10.03 min) for Amicus. Higher platelet counts were observed in SDPs obtained from the Amicus cell separator. All the above variables were statistically significant [Table 5].
|Table 5: Comparison of operational and product variables among cell separators|
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Fifty-one of 200 procedures done on Amicus cell separator, platelet yield obtained was >3.5 × 1011. Platelet yield was obtained between 3 and 3.5 × 1011 in 57.5% procedures in Hemonetics MCS +.In COM. TEC maximum products (54%) had a yield less than <3 × 1011. Mean platelet yield was maximally seen in the Amicus cell separator followed by Hemonetics MCS + and COM. TEC [Table 6].
Platelet yield was correlated with other variables. A positive correlation was seen with donor pre-apheresis platelet count (r = 0.258), and the correlation was statistically significant (P < 0.001). Similarly, platelet yield correlated positively with donor blood volume processed and product volume obtained, but the correlation was not statistically significant. Platelet yield correlated negatively with donor pre-apheresis Hb level. The correlation was statistically significant (P < 0.001) [Table 7].
| Discussion|| |
Two hundred procedures each were done on three different cell separators. All donors were male. None of the females had fulfilled the inclusion criterion of the study either due to less weight or Hb <12.5 g/dl. Donors were ranging from 19 to 47 years, with the majority of donors between 19 and 30 years age group (70.5%). The mean weight of the donor was 73.39 ± 8.73 kg. Donor height ranged from 160 to 188 cm. Maximum donors (74.66%) in the study population had their height from 170 to 179 cm. The mean height of donors was observed at 173.53 ± 4.22 cm. The mean height of donors was 174.78 ± 4.12 cm on Hemonetics, 173.05 ± 4.13 cm on COM. TEC, 172.77 ± 4.15 cm on Amicus and was observed statistically significant between all three cell separators. Results of the present study were comparable to the study done by Altuntas et al.
In the present study preapheresis and postapheresis, hematological values were observed in all SDP donors. However, the difference was significant only in mean preapheresis Hb levels with no statistically significant difference in mean pre-apheresis Hct levels and mean preapheresis platelet counts. Differences in donor pre- and post-apheresis Hb, Hct, platelet counts were statistically significant. All cell separators in our study showed a significant reduction in postprocedural donor Hb, Hct, and platelet counts (P < 0.0003 for Amicus and Hemonetics, P < 0.0004 for COM. TEC) after each procedure. Similar results were found in the study done by Das et al. Tendulkar and Rajadhyaksha also observed reduced blood counts in donors taken on Amicus cell separator. The mean percentage of Hb loss, Hct loss, and platelet loss were 5.61 ± 2.44, 3.79 ± 1.48, and 27.08 ± 6.05, respectively, in the present study. The mean percent reduction for Hb, Hct, and PLT was 2.9, 3.1, 30.7 (N = 237) in a study by Tendulkar and Rajadhyaksha. Decrease in Hb and Hct with Amicus was significantly greater than COM. TEC and Hemonetics MCS + equipment (P < 0.001) in our study. Platelet reduction was significantly greater with COM. TEC than with Amicus and Hemonetics MCS + (P < 0.001). Similar results were reported in other studies. In the present study, a statistically significant difference was observed in blood volume processed between all the three cell separators, and higher values were noted in Amicus than COM. TEC and Hemonetics. This was because of significantly lower pre apheresis Hb levels and higher pre apheresis platelet count in the donors on COM. TEC.
A significant difference was noted in the duration of the procedure between all three cell separators in the present study. The mean duration of the procedure was observed maximum for COM. TEC (56.91 ± 8.42 min) and minimum for Amicus (50.69 ± 10.03 min). Target platelet yield is achieved more rapidly with Amicus as compared to COM. TEC and MCS +. Similar results were found in the study done by Shaikh et al. in 2019. Altuntas et al. also showed a median separation time of 44 (37–58) min on Amicus and 61 (48–72) min on COM. TEC. Similarly, a study on COM. TEC was done by Moog et al. on 342 procedures and observed an average blood volume processed of 2,826 ± 409 ml in 55 ± 11 min Strasser et al. also reported a processed blood volume of 2.49 ± 0.50 L and a mean separation time of 54 ± 13 min using COM. TEC cell separator.
The study showed a statistically significant difference in product volume collected between all three cell separators. Higher volume was obtained with COM. TEC followed by Amicus and Hemonetics. Similar results were reported by other authors.,. Higher platelet counts were observed in SDPs obtained from the Amicus cell separator. Maximum platelet yield was 3.59 ± 0.54 × 1011 observed in the product obtained from the Amicus cell separator, followed by Hemonetics and COM. TEC. The difference was statistically significant between all three cell separators. A study done on Hemonetics showed a mean platelet yield 2.9 ± 0.64 × 1011. Similar results were observed in another study done on Amicus and COM. TEC was 3.39 (2.84–4.03) ×1011 and3.33 (2.87–3.94) ×1011. Other studies observed platelet yield as 3.11 ± 0.40 × 1011 and 2.9 × 1011 on COM. TEC cell separator.,
In the present study platelet yield correlated positively with donor preapheresis platelet count (r = 0.258), blood volume processed (r = 0.0103) and plasma volume collected (r = 0.0482). This means that if higher is the donor pre apheresis platelet count and donor blood volume processed or the product volume obtained, the higher is the platelet yield in the product. Platelet yield correlated negatively with donor pre-apheresis Hb level (r = −0.3701) and duration of the procedure (r = −0.298). A negative correlation with pre apheresis Hb levels means that if higher is the pre apheresis Hb level, lower is the product platelet yield. The correlation was observed statistically significant with donor pre-apheresis Hb level, donor preapheresis platelet count, and duration of the procedure (P < 0.001) and insignificant with blood volume processed and product volume obtained. A positive correlation was seen between the preprocedural donor platelet count and product yield in a study done by Tendulkar and Rajadhyaksha Guerrero-Rivera et al. observed a direct relation between these two parameters and reported an inverse relationship between Hb and platelet yield. Similarly, in a study done by Enein et al., a positive correlation was observed with platelet pre count, processing time, volume processed, and the volume of plasma obtained and negative correlation with donor pre-apheresis Hb (r = −0.306).
Having such a large donor population and their willingness to participate in the study was the strength of the study. SDP donation being the directed donations, we were unable to recruit the donor to a particular cell separator as per the study requirements, which was a limitation of our study.
| Conclusion|| |
The present study concludes that the main predictors of platelet yield are platelet pre-count and volume processed. Donors with lower Hb had better yields because of more plasma being processed. The higher platelet counts mean more platelets are available for collection. The target platelet yield is achieved more rapidly with Amicus as compared to COM. TEC and Hemonetics MCS +.
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Conflicts of interest
There are no conflicts of interest.
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Senior Resident, Department of Immunohematology and Transfusion Medicine, SMS Medical College and Hospital, Jaipur, Rajasthan
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]
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