| Abstract|| |
BACKGROUND AND OBJECTIVES: High-yield plateletpheresis donations can reduce donor exposure and be economically beneficial as well. However, obtaining a high-yield plateletpheresis from a maximum number of donors with low basal platelet count and its effect on postdonation platelet count of donors undergoing high-yield plateletpheresis has been a matter of concern. This study aimed to assess the feasibility of making high-yield platelet donation as a routine practice.
METHODS: It was a retrospective observational study to determine the effect of high-yield plateletpheresis on donor reactions, efficacy, and quality parameters. It was conducted from January 1, 2019 to June 30, 2021, at the Department of Transfusion Medicine in a tertiary care hospital of South India.
RESULTS: Out of the 669 procedures, 564 (84.3%) of the collection had a platelet yield of ≥5 × 1011, 468 (70%) of the collection had a platelet yield of 5.5 × 1011, whereas 284 (42.5%) met the target of 6 × 1011 by coulter. The mean drops in platelet count were 95 ± 16 × 103/μl (77,600–113,000/μl), mean platelet recruitment was 1.31 ± 0.51. The mean collection efficiency of the procedure for the 669 cases was shown to be 80.21 ± 15.34, and the mean collection rate was 0.07 × 1011 ± 0.02 per minute. Only forty donors (5.5%) experienced adverse donor reactions.
CONCLUSIONS: High-yield plateletpheresis can be done in routine practice with no added adverse donor reaction with effective quality products.
Keywords: Donor reactions, high-yield plateletpheresis, platelet yield, Trima Accel
|How to cite this URL:|
Sahoo D, Noushad S, Basavarajegowda A, Toora E. Feasibility of high-yield plateletpheresis in routine practice: Experience from tertiary health center from South India. Asian J Transfus Sci [Epub ahead of print] [cited 2023 Mar 23]. Available from: https://www.ajts.org/preprintarticle.asp?id=356850
| Introduction|| |
Platelets collected via plateletpheresis are known as single donor platelets (SDP). They usually have a single adult dose platelet of 3 × 1011 per unit. Double and triple doses of platelets can be collected by the Apheresis technique. Apheresis platelet transfusion decreases the unnecessary allogeneic component exposures, thereby reducing alloimmunization, platelet refractoriness, and threat to transfusion-transmitted infections (TTI). It also provides platelets in large amounts to patients. Thus, it is particularly important to patients who need recurrent platelet transfusions such as hematological, oncological, and posttransplant patients. The plateletpheresis procedure is considered safe from the donor's point of view, and the SDP product is effective from the recipient's point of view. Before 2010, more than 95% of platelets were derived from whole blood donations in India, and only 5% were apheresis platelets, but nowadays, there is a gradual increase in the utilization of apheresis platelets. High yield platelets are described differently by different researchers. Klumpp et al. defined platelet yield of >5 × 1011, while Makroo et al. defined a target yield of 6 × 1011 as high-yield plateletpheresis., Few studies have been published from India on high-yield plateletpheresis but none of the centers does it regularly.,, Plateletpheresis is done on-demand, and it is a directed donation in our setup. The majority of the SDP collected in our center is for cancer patients, and it is collected as double dose platelets of 6 × 1011 per donation, split into two units aimed to use in the same patients, reducing the economic burden on the patients. This study aimed to study the effect of high yield platelet collection on donor hematological parameters, evaluate the quality of products, and analyze adverse donor reactions.
| Materials and Methods|| |
The present study is a retrospective observational study conducted at the Department of Transfusion Medicine, in a tertiary care hospital of South India, India, from July 2019 to June 2021. Ethical approval was obtained from Institute Ethics Committee.
All the donors for the plateletpheresis procedures were selected based on the eligibility criteria outlined in the Transfusion Medicine Technical Manual by the Director-General of Health Services (DGHS), Ministry of health and family welfare, Government of India. As per departmental standard operating procedure (SOP) following criteria were used for selecting the high-yield plateletpheresis donors: Preprocedural platelet count of minimum 2.2 lakhs/ul, the weight of 55 kg and above, belongs to the age group of 18–60 years, prominent, accessible vein for withstanding the lengthy procedure, minimum of 1-week gap after last plateletpheresis and 28 days after last whole blood donation, same or compatible ABO grouping as the intended patient, and if necessary same Rh typing as well. A pre-platelet count of 2.2 L was set in the SOP to maximize the likelihood of deriving SDP and producing double unit plateletpheresis as per study by Wollersheim et al.
Donors were also subjected to Pre-apheresis Complete blood count and the Mandatory TTI screening. Blood grouping and Rh typing with atypical antibody screening using in-house prepared pooled O cells were also done in all the subjects prior to starting the procedure. All the preaphaeresis investigation parameters should be within an acceptable limit and should be negative for TTI screening. Donor details including age, gender, height, weight, blood volume, pulse, blood pressure, and temperature were recorded for all donors. Phlebotomy was done using the antecubital vein in all the donors. All the procedures were done using Trima Accel (Terumo Penpol, Lakewood, USA) with single needle kits.
Collection of procedural data
Procedural data were collected from the SDP procedure register maintained for recording each procedural detail. The preprocedure hematology values were obtained from the donor screening register, where donor details are maintained. The following donor data were fed into the Trima Accel cell separator: Gender, weight, height, blood group, hematocrit, and platelet count. The target volume and yield were kept 400 ml and 6 × 1011, respectively, for all the high-yield plateletpheresis procedures, and the total blood volume (TBV) to be processed for the target yield was automatically estimated by the device. The information displayed at the end of donation, including TBV processed, total acid citrate dextrose (ACD) used, total duration, post-procedure platelet and hematocrit, yield, and final volume collected were recorded for calculating the collection rate, collection efficiency, and platelet recruitment.
The quality of each product was done after the collection on the same day or the next day as most of the products are issued before day 3 of collection. Swirling, volume of the product, platelet count per unit, leucocytes per unit, and red cell contamination were recorded for all the units. Sterility testing and pH were done on 1% of the products collected. All the hematological parameters of the bag were done by coulter, pH by pH meter (Labman), and sterility testing was done by BactAlert. As per Indian standards, 75% of the SDPs have to meet >3 × 1011 per unit.
The collection rate is the yield obtained per hour by an automated cell separator. Calculated using the formula given below:
Collection rate2 = cells in the product bag/total procedure duration in hours
Collection efficiency refers to how many cells of interest are actually collected in the product bag relative to the number of the processed cells that pass through the instrument. It is often calculated as a quality metric. It is calculated by the following formula.
Collection efficiency2 = (cells in the product bag/platelet average × TBV processed) ×100
Platelet average = (pre-platelet count + post-platelet count)/2
TBV processed = blood volume processed – ACD-A used
Platelet recruitment is defined as the ratio of total platelet in the bag to the reduction in circulating platelets in the peripheral blood of the donor, and recruitment is assumed when it is more than 1.
Platelet recruitment2 = total platelet in the product/Pre-platelet-Post platelet × Donor TBV
Adverse donor reaction monitoring during the procedure
All the donors were monitored during the procedure and until 30 min after completing it as per departmental SOP. Two tablets of 500 mg Calcium tablets (Calcium carbonate) were offered to each donor before donation and whenever the donor had symptoms of hypocalcemia. Donor vitals (pulse, blood pressure, temperature) were recorded before initiating the procedure and when the donor complained of any symptoms. All the adverse donor reactions were complained about by the donor or observed by the staff during the procedure, or within 30 min of procedure, completion was recorded.
Statistical analysis was performed employing the SPSS version 23 statistical package from IBM Corporation Ltd. Armonk, New York, USA. All qualitative variables were reported as frequencies and percentages. Quantitative variables were represented as mean and standard deviation (SD). A P < 0.05 was considered statistically significant.
| Results|| |
During the study period from January 2019 to June 2021, a total of 730 donors underwent a high-yield plateletpheresis procedure in our institute. Of these, complete data were available for 669 donors, which are included in the analysis. Donors, <30 years contributed to 70% of study subjects. Only 3.2% belonged to the age group 48–55 years. Around 98% of the study population were male. About 61.3% of the total donation were replacement donations, and 62.5% were first-time SDP donors though they have donated whole blood at least once. While considering the blood group of the donors, the majority belonged to the B group, and the order of the blood group was B > O>A>AB. Donor demography and preprocedure laboratory values are summarized in [Table 1].
|Table 1: Donor demography and predonation hematology reports of 669 donors (n=669)|
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Results of all performance indices for both product and the high-yield plateletpheresis procedures are summarized in [Table 2]. The Indian standards for SDP donations were satisfied as 98.4% of the products met the minimum criteria of ≥3 × 1011 platelets and a WBC count of ≤5 × 106 per product. The eight (1.6%) donations with a yield of <3 × 1011 were incomplete procedures due to donor reactions or procedure failures. The volume of the products (>200 ml), red cell contamination(<0.5 ml) were met by all the units collected. Sterility testing of all the tested units was negative and pH was between 6.2 and 7. Though the target volume and yield were kept 400 ml and 6 × 1011 respectively for all the procedures, 81 (12.1%) procedures had to be stopped prematurely resulting in a machine yield of <6 × 1011 due to various reasons like low flow (19), one bag of ACD was used-up (23), donor reactions (16), double prick and donor unwilling to continue (9), and technical issues (14). We observed a mean platelet yield of 5.84 × 1011 by Coulter and 5.81 × 1011 by the machine. The machine processed a mean TBV of 3568 ml, and the mean product volume collected was 393.71 ml.
A total of 40 (5.5%) donors experienced adverse donor reactions. Phlebotomy-related donor reactions, including double prick and development of hematoma, were the maximum (31 [4.3%]) followed by hypocalcaemic reactions (five, 0.6%). Hypocalcaemic symptoms included perioral numbness and tingling sensations of the limbs. Of the three donors with vasovagal reactions, 2 experienced a mild reaction (dizziness, nausea, and vomiting) [Figure 1]. A 19-year-old first-time male donor experienced a loss of consciousness at a 1.9 yield of collection by machine with 1538 processed blood volume, and the procedure was aborted. The second phlebotomy due to continuous low flow alarms by the machines has to be done in 16 donors. The observed adverse donor reactions were associated with TBV processed, ACD to donor, volume of the product collected, and yield of the product, as shown in [Table 3].
|Figure 1: The observed adverse reactions during high-yield plateletpheresis|
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Postprocedure platelet count and platelet recruitment
The lower limit set for the postprocedure platelet count by machine was 100 × 103/μl. We obtained a median postprocedure platelet count of 184 × 103/μl (range –103–331). The mean drops in platelet count were 95 ± 16 × 103/μl (77,600–113,000/μl), and it showed a significant positive correlation with the yield. We observed mean platelet recruitment of 1.31 ± 0.51.
Yield, collection efficiency, the collection rate
The mean collection efficiency of the procedure for the 669 cases was shown to be 80.21 ± 15.34, and 77.9% (521) comes within one SD. We observed a positive statistically significant correlation of collection efficiency with the yield, TBV processed and Duration of the procedure [Table 4]. The mean collection rate was 0.07 × 1011 ± 0.02 per minute, i.e., an average of 3.17–5.26 × 1011 is collected per hour. Collection Rate has shown a positive correlation with yield, a statistically significant negative correlation with TBV Processed by the machine and no correlation with Total Duration of the Procedure [Table 5].
|Table 4: Correlation of collection efficiency with yield, total blood volume processed, and duration of the procedure|
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|Table 5: Correlation of collection rate with yield, total blood volume processed and duration of the procedure|
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| Discussion|| |
Recent data shows a steady increase in the collection of platelets by apheresis techniques than from whole blood donation. It is shown that 92% of the platelets used in the United States are from the apheresis technique. The main advantage of using such platelets is that it reduces multiple donor exposures and provides a full dose from a single donor. High yield collection can further decrease the exposure rate, providing a more significant advantage to the frequently transfused hemato-oncological and post-transplant patients as it can significantly reduce the chance of alloimmunization and platelet refractoriness. In addition, it can provide a high-quality product with consistent and standardized yield and product volumes. Moreover, with the advances in technology, it is now possible to collect high yield platelet from a single donation with a better donor safety profile. We used Trima Accel with software version 6.0, which has shown increased donor safety and collection efficiency for high yield collection.
The primary aim of this study was to determine the feasibility of doing high yield/double unit platelet apheresis (DUP) in routine practice. The collection of high yield platelets can overcome the limited donor supply to some extent and reduce the financial burden on patients. In our center, we routinely collect high yield platelets from donors having a preplatelet count of 220 × 103/μl. No studies are available on the optimal platelet count for the collection of high yield. According to AABB, the minimum preplatelet count required for DUP is 300 × 103/μl. However, only 30.9% of the screened donors have a platelet count of ≥300 × 103/μl. The Indian regulatory agency called the Drugs and Cosmetics Act has no guidelines for high yield platelet collection. Glicher and Smith, Chaudhary et al. and Jaipian et al. found that donors should have a preplatelet count of 250 × 103/μl for double unit collection.,, Although 75% of the screened donors have a platelet count of 250 × 103/μl the deferral rate is still higher due to poor vein status as a good volume vein is essential to support the longer duration of high-yield plateletpheresis. Furthermore, to meet the high demands of platelets from our oncological, transplant, hematological and surgical patients and overcome the difficulty of obtaining donors, we selected platelet donors with 220 × 103/μl for high-yield plateletpheresis. In one study by Wollersheim et al., they had shown that preplatelet counts positively correlated with the final platelet yield in the high yield and recommended to defer donors with a preplatelet count of <225 × 103/μl for as it significantly reduces the yield. In the present study, we could get high yield platelets with count >220 × 103/μl.
A study by Fontana et al. has shown significant platelet recruitment during high-yield plateletpheresis using Trima Accel. Therefore, the real postplatelet count will always be more than the predicted postplatelet if this increase in platelets by platelet recruitment is not being utilized in the algorithm used to calculate the postplatelet count by the device. This will limit the platelet collection earlier than the cut-off given by the FDA for postplatelet, which is 100 × 103/μl.
In Trima Accel version 6.0, a modified algorithm based on the observed recruitment has been installed, supporting high yield collection with better donor safety. This is evidenced in our study as all the donors had a postplatelet count of more than 100 × 103/μl (minimum-103 × 103/μl). Our data showed a median post platelet count of 184 × 103/μl and a mean platelet loss of 95 ± 16 × 103/μl (77,600–113,000/μl). For safety purposes, the FDA has recommended not to allow the post platelet count to go below 100 × 103/μl. Based on the donor hematocrit, preplatelet count, estimated TBV of the donor and the minimum acceptable post platelet count, the apheresis devices calculate the platelet yield that is achievable in a given time.
The mean platelet recruitment in our study was 1.31 ± 0.51, and it is 1.33 ± 0.60 in a study by Kumawat et al. Platelet recruitment was present in 90% of the donation, and the reason for the absence of recruitment in the remaining may be due to individual variation in the splenic sequestration of platelets. Platelet recruitment is defined as the ratio between actual yield obtained by the machine to the predicted platelet yield calculated using donor TBV and the difference between preplatelet and postplatelet. Platelet recruitment is used to predict the post platelet by the newer version devices. In a study, recruitment is shown to be higher in Trima Accel when compared to Amicus. The earlier calculation of postplatelet prediction was based on target platelet yield, preplatelet, and estimated donor TBV, which actually underestimated the real post-procedure platelet count.
In the current study, 98.5% of the products collected during the study period met the yield ≥3 × 1011. The volume of the products, leucocytes per unit, and red cell contamination were meeting AABB and DGHS criteria. All were sterile, and pH were between 6 and 7. Out of the 669 procedures, 284 (42.5%) met the target of 6 × 1011. More than 2/3rd (468/669, 70%) of the collection had a platelet yield of 5.5 × 1011, whereas 84.3% had ≥5 × 1011. Three studies from India by Makroo et al., Chaudhary et al. and Vijay kumavat et al. have adopted a platelet yield of ≥6 × 1011, ≥5.5 × 1011, and ≥5 × 1011 respectively as the acceptance criteria for DUP and the number of donors meeting the respective yield in each study were 33.97%, 19.8% and 33.07%.,,
The observed adverse donor reactions were 5.5%, almost similar to 5.8% reported by Dogra et al. It is lesser compared to other studies from India where the adverse reactions reported were 7.22% by Kumawat et al. and 10.2% by Chaudhary et al., The probable reason for less donor reaction rate may be due to meticulous monitoring by assigned personnel exclusively for the apheresis donors and separate section for apheresis procedures. There was no association of adverse reactions with donor weight, TBV, preplatelet count, and total duration but significant association with the volume of product, yield of product, TBV processed, and ACD infused to the donor as shown in [Table 3]. The majority of the reactions were hematoma (4.3%), followed by hypocalcemic reactions. Only 0.6% of donors had hypocalcaemic reactions in our study, which was much lesser compared to the hypocalcemic effects reported by Keklik et al. (8%) and 8.75% by Makroo et al., All donors were received prophylactic oral calcium of 1 gram before the procedure. The rate of vasovagal reactions was only 0.5% (only 4 donors) which was much lower than reported by other investigators from India., There was no serious adverse reaction that could lead to early completion of the procedure except one, where the donor experienced a loss of consciousness. The reduced adverse reaction supports our view of the routine practice of DUP in donors with sufficient blood volume and a minimum pre-platelet count of 200 × 103/μl. Moreover, the newer apheresis devices have software algorithms that determine the donor's eligibility and donor safety.
The mean collection efficiency for the 669 procedures was 80.21 ± 15.34% which was higher than the previous studies by Kumavat et al. (0.74 ± 0.10) and Keklik et al.(74.99 ± 14.40%), which was collected using Trima Accel with software versions of 5.1 and 5.0 respectively., The majority of the donation is contributed by male donors as female donors are deferred more frequently due to low Hb (<12.5 g/dL). TBV processed by the machine showed a mean of 3574 ml (SD = 683.91). The main limitation to our study was that we could not assess the postprocedure sample for the exact reduction of platelet count, Hb and hematocrit values since it was a retrospective study. All the donors had a Hb of 12.5 g/dl and above, and the mean difference between the pre and post hematocrit was 1.1% suggesting a Hb loss of <0.5 g/dl.
| Conclusion|| |
High-yield plateletpheresis with 5.5 × 1011 yield can be done safely in routine practice even with a preplatelet count of 220 × 103/μl by increasing procedure time. These donations can reduce donor exposure further as well as add economic benefits to the patients. We hope that our data can guide in performing high-yield plateletpheresis using high-end machines.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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Department of Transfusion Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]