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 Table of Contents  
ORIGINAL ARTICLE
Year : 2017  |  Volume : 2  |  Issue : 2  |  Page : 149-154

Various aspects of plateletpheresis: Its impact on donor and patients


1 Department of Transfusion Medicine, AIIMS, Bhubaneswar, Odisha, India
2 Department of Transfusion Medicine, SCB Medical College, Cuttack, Odisha, India

Date of Web Publication11-Sep-2017

Correspondence Address:
Dibyajyoti Sahoo
Department of Transfusion Medicine, AIIMS, Bhubaneswar, Odisha
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/GJTM.GJTM_24_17

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  Abstract 


Background and Aim: Platelet transfusion plays an important role in the treatment of hematological, oncological, surgical, and transplant patients. Aphaeresis technology is widely available in the world and some part of India, but it is new for our region. The present study aims at various aspects of plateletpheresis including donor safety, donor hematological changes following single donor platelet (SDP) donation, quality of product, and impact on patient following SDP transfusion. Materials and Methods: Preprocedural hematological count such as total platelet count (TPC), hemoglobin, red blood cells, and white blood cells count was recorded. All donors were observed for adverse donor reactions. Postdonation (after 30 min) sample was drawn to see the hematological parameters and compared to that of pre donation hematological parameters. Quality control of all SDP products was done. All recipients were observed for any transfusion reactions. Post 24 h transfusion sample was obtained from the SDP recipient and compared to that of pretransfusion sample to see the platelet increment. Results: A total of 135 plateletpheresis procedures were performed on cell separator. SDP was collected from the donors as per standard operating procedure. All donors were observed for adverse donor reaction. We found an adverse event with one donor. There was decrease in mean value of all hematological parameters in the postdonation sample. There was no thrombocytopenia either clinically or from laboratory value. Similar trend was seen with double yield collection. Mean acid citrate dextrose (ACD) used was 328, mean blood volume processed 3385 ml, mean product volume was 249 ml, mean time was 76.8 min during the procedure. Quality control of all SDP products was done. Mean yield was found to be 4.18 ± 0.95 × 1011 per unit. A positive correlation was seen between pre TPC of donor and product yield. Post 24 h transfusion sample was obtained from the SDP recipient and compared to that of pretransfusion sample to see the platelet increment. We observed mean increment of platelet count to be 76.15 × 109/L. Overall therapeutic benefit was observed in all cases. Conclusion: The study found that plateletpheresis procedure is very safe from donor point of view and SDP product is effective from recipient's point of view.

Keywords: Plateletpheresis, quality, yield


How to cite this article:
Sahoo D, Mahapatra S, Parida P, Panigrahi R. Various aspects of plateletpheresis: Its impact on donor and patients. Glob J Transfus Med 2017;2:149-54

How to cite this URL:
Sahoo D, Mahapatra S, Parida P, Panigrahi R. Various aspects of plateletpheresis: Its impact on donor and patients. Glob J Transfus Med [serial online] 2017 [cited 2017 Nov 20];2:149-54. Available from: http://www.gjtmonline.com/text.asp?2017/2/2/149/214290




  Introduction Top


Apheresis refers to any procedure during which blood is withdrawn from the donor or patient and separated ex vivo into some or all of its components. Plateletpheresis referred to a procedure in which a portion of the donor's platelet and some plasma is removed with the return of the donor's red blood cells (RBCs), white blood cells (WBCs), and remaining plasma. The product is also known as single donor platelet (SDP). Routinely, the number of platelets in an apheresis product is equivalent to 6–8 random platelet concentrates. SDP has unique advantages such as leukoreduced product, can be human leukocyte antigen matched, and platelet-antigen-compatible phenotypes. By design, aphaeresis procedures are intended to collect large numbers of platelets from an individual, thereby providing a more consistent product with fewer donor exposures for the patient.

The safety issue of donors with regard to postprocedure platelet count, hemoglobin (Hb), WBC and other hematological parameters is always a concerned. According to few authors, donors undergoing plateletpheresis may have a transient but significant decrease in complete blood count.[1],[2] Literature search on above subject provide somewhat controversial data; one study found there is increase Hb, hematocrit (Hct), WBC, after plateletpheresis while other authors describe significant fall in these parameters.[2],[3],[4] Apheresis procedure is usually well tolerated. Adverse donor reactions may occur during or after the procedure. It may be local reaction or systemic reaction.[5],[6] Local reactions can be hematoma, pain, swelling, phlebitis. Systemic reactions are mainly vasovagal. Citrate toxicity may occur due to the use of acid citrate dextrose (ACD) in apheresis.[7],[8],[9]

The quality of the product is most important factor which will decide therapeutic benefit to patients. The American Association of Blood Bank (AABB) standards requires that an apheresis platelet component contain at least 3 × 1011 platelets in 90% of sampled units.[10] Leukocyte count of the apheresis platelet must be <5 × 106 as per AABB Standards and <1 × 106 as per European guidelines. The red cell contamination should be <0.5 ml. Platelet increment in a patient is influenced by the transfused dose of platelets which in turn is dependent on the platelet yield.[11] Obtaining higher platelet yield has important clinical implications: It reduces the frequency of platelet transfusions and number of donor exposures with important consequent clinical and economic advantages.[12],[13] Aphaeresis technology is widely available in world and many parts of India. The present study aims at exploring all the aspects of plateletpheresis and its products including postprocedure hematological change in donors, adverse donor reaction if any; quality of product, therapeutic benefits to patient, etc.


  Materials and Methods Top


A prospective study on plateletpheresis was conducted in the multispecialty tertiary care Hospital, Cuttack, Odisha from May 2015 to August 2016. Donors were well counselled. Detail medical history was obtained. Donors screening was done as per guidelines of Transfusion Medicine Technical Manual, Directorate General Health Services (DGHS), Government of India, New Delhi.[14] Venous status of both arm cubital veins was observed. Physical examination was done. Height, weight recorded Blood samples were obtained for complete blood count, confirmation of blood group, and screening of transfusion transmitted infections. If donor was found eligible for the plateletpheresis procedure then written consent was obtained for the procedure.

SDP collection was done using Cobe Spectra, Terumo Penpol, double access needles with version 7 software programs and leukoreduction system. The anticoagulant (AC) infusion rate was 1.1 ml/min/l total body volume. (Range is from 0.8 to 1.1 ml/min/l total blood volume so that there will be minimum adverse effect of AC on donor). The AC ratio was 8:1 (seven part whole blood one part AC) for 10 min, 9:1 for 10 min, 10:1 for 10 min, 11:1 for rest of the procedure. The yield scaling factor was 1.00. The collection concentration monitoring (CCM) scaling factor was 0.9. During plateletpheresis, CCM monitors for leukocyte and red cell spillovers and estimates optically how many platelets have been collected. If a spillover occurs, the CCM repositions the collect valve to return the resulting contaminated product to the donor until the line has cleared. Yield scaling factor help to correlate actual yield to that of predetermined yield.

Study design

All the requisitions coming from various departments for SDP were included in the study domain. Donors were screened and deferred if not found eligible. Causes of each deferral were noted. A total of 135 donors were found fit for plateletpheresis after clearing all screening criteria. Calcium tablet (1 g) was given to them orally few minutes before the beginning of the procedure. They donated the platelets in the cell separator. All donors were observed for any adverse reactions. Procedure details such as time taken, blood volume processed, ACD used, and product volume were recorded. After the procedure, they were asked to remain at rest for at least 30 min. Second sample was obtained after 30 min of procedure to observe hematological changes. Pre- and post-donation parameters of donors were compared.

Each product was inspected visually. Quality control was done for platelet yield, WBC, RBC, contamination in the product using standard calibrated hematology analyzer (Sysmex XP 100). SDP was issued with necessary advises like-transfuse as soon as possible, do not refrigerate, etc., Patients were observed for any transfusion reaction following SDP transfusion. After 24 h, patient's samples were obtained to see the platelet increment and compared with pretransfusion count. Overall therapeutic benefits were recorded in all recipients. Pre- and post-hematological parameters were determined. Quality control of each SDP product was done and compared to the standards of DGHS [14] NABH [15] (National Accreditation Board For Hospitals) and AABB.[10] SDP product was issued to the patient. Patients were observed for any transfusion reaction. Posttransfusion count of total platelets observed in all patients at 24 h and compared with pretransfusion count. We observed following parameters in patients:

  1. TPC 24 h following SDP transfusion
  2. Improvement in bleeding conditions following SDP transfusion
  3. Any transfusion reaction such as transfusion related acute lung injury (TRALI), transfusion associated circulatory overload, allergic, febrile non hemolytic transfusion reactions (FNHTRs)
  4. Improvement in petechial and purpuric rashes following transfusion
  5. Any mortality of recipient with in 24 h of SDP transfusion.


The final observation was made on each patient on morbidity, mortality, improvement of conditions, overall therapeutic benefits.


  Results Top


A total of 135 platelet procedures were performed. Total requisitions received during the study period were 540. Out of these 89 cases could not arrange donor for the procedure. One hundred ninety-two cases could not afford money for the said procedure. A total of 259 donors attended the department for plateletpheresis. Donor screening was done and 124 found ineligible. Various causes of deferral are mentioned in [Figure 1]. All the donors were male, age of donors varied from 18 to 50 years, with mean age 30.48 ± 7.67 years, mean weight was 77.1 ± 7.5 kg, and mean height 165 ± 14.7 cm. Predonation platelet count [Table 1] of donors varied from 155,000 × 109/ L to 3, 81,000 × 109/ L. The time taken for SDP procedure varied from 60 min to 100 min (mean time 76.8 ± 9.55 min). Mean blood volume processed was 3385 ml. Mean ACD used was 328 ml. Volume of product varied 180 ml to 367 ml with mean 249.17 ± 46.14 ml. Yield of product varied from 2.1 to 6.7 × 1011 platelet count/bag and mean platelet count of bag found to be 4.18 × 1011 (±0.95). Correlation between TPC and yield done [Table 2]. Quality control of all the SDP shows there is yield in all cases were >3 × 1011 except seven cases had <3 × 1011 but >2 × 1011/bag [Figure 2], whose pre-TPC was low and had low blood volume. Observation of 135 SDP donors showed there is only one adverse donor reaction which was a local bruise of mild variety.
Figure 1: Donor deferral

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Table 1: Number of donor distribution as per total platelet count

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Table 2: Correlation between platelet count and product yield

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Figure 2: Single donor platelet yield of products

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Comparing individual pre- and post-donation hematological parameters, there is decrease in platelet count seen in all cases with postdonation 30 min sample. WBC, RBC, hemoglobin and Hct varied around 5% of original value, may decrease (most cases), increase (some cases), or remained same (few cases). Double yield was prepared in 12 cases, in these cases, hematological parameters showed similar trends as above [Table 3] and [Figure 3]. Platelet increment following SDP transfusion was good (varied from 60,000/μl to 100,000/μl in 78 episodes, more than 100,000/μl in 21 cases, 30,000/μl to 60,000/μl in 25 times). In six cases, the increment was <30,000/μl and no increment seen in five cases (ALL with big spleen). Mean increment of platelet count in patients found to be 76,156 ± 3397μl (seen at 24 h following SDP transfusion). Troubles were noticed in 39 cases. Common trouble shootings were spillage over (11 procedures), low access pressure (twenty procedures), and nonincrease of CCM (8 procedures). Of 135 SDPs, adverse transfusion reactions were only 1 (allergic).
Table 3: Pre- and post-donation hematological parameter change (mean)

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Figure 3: Postdonation reduction of blood count in double yield collection

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  Discussion Top


Platelets are essential for the formation of primary hemostatic plug and maintenance of hemostasis. Platelet acts by two of its important functions, i.e., (1) Get adhered to exposed subendothelium with subsequent formation of aggregates at the site of vessel injury. (2) Facilitate thrombin and fibrin formation to strengthen these aggregates. Platelet transfusions are needed either prophylactic or therapeutic. Pool of 4–6 units of random donor platelet or one unit of SDP is transfused.

During the study, we received total 540 requisitions for plateletpheresis. Out of these, 89 (16.5%) could not arrange donor, 192 cases (35.5%) could not afford financially, 124 cases (22.9%) were not found eligible due to various reasons and 135 (25%) cases were selected for the procedure. Analyzing various causes of donor deferral [Figure 1], we found low TPC is to be the most important cause which accounted for 29% deferral. The similar finding was found by Pandey et al. in their study from Northern India.[16] Low platelet count to be important cause of donor deferral was also mentioned by Tondon et al.[17] 29 (23%) of the deferral were due to poor venous access. We found most of our donor had platelet count between 150,000/μl and 350,000/μl (96.8%). A similar result was found by Tendulkar and Rajadhyaksha [18] In their study, they had 92.8% donors whose platelet count was between 150,000/μl and 350,000/μl. In present study [Table 1], only four had platelet count between 350,000/μl and 400,000/μl none of our donor had pre platelet count more than between 4,00,000/μl. Mean ACD used was 328 ± 33.1 ml. Cobe spectra uses less ACD has been shown by some authors.[18]

Effects of single apheresis procedures have been studied extensively, especially in the setting of platelet donation. The impact of plateletpheresis on healthy donors with the Cobe Spectra at the time of its introduction [19] showed that mean pre-and post-donation platelet counts were 288,000/μL and 217,000/μL, respectively, whereas mean WBC counts dropped from 7000/μL to 6120/μL. Mean Hct decreased from 44.9% to 43.6%, whereas mean Hb increased slightly from 14.06 g/dL to 14.79 g/dL, and the mean red cell count was unchanged. Reduction in donors hematological value after plateletpheresis without clinical manifestations have been reported by many researchers.[2],[4] Comparing our result [Table 3] to other studies on the same machine during its introduction showed that there was reduction in platelet, WBC, Hct like that of ours.[19] Our study showed that there is mild decrease in hemoglobin & RBC mass which was not similar to what they have reported. Another published article [4] has showed decrease in platelet, WBC, Hct, Hb with Cobe Spectra, which is similar to our findings. Kalish et al. found a 29.4% decrease in platelet count after donation, which was not clinically significant.[20] In the present study, we found 34% decrease in platelet count in comparing to predonation count and found clinically insignificant.

Donors with preplatelet count >300,000/μl were subjected to double yield collection. Double yield prepared in 12 cases, hematological parameters shows more reduction of TPC than single yield with postmean TPC 177,000/μl, and none of them had value <100,000/μl. WBC, RBC, HB, and HCT had similar trends as of a collection of single yield [Figure 3]. Richa et al. examined the effect on platelet and WBC counts of double-and triple apheresis donation of platelets.[21] They found a small but statistically significant increase in platelet count (rather than a decrease). Our finding shows there is decrease in platelet count with double yield collection, and donor had no deleterious effect on them if the pre-TPC is >300,000/μl. Correlation between predonation platelet count and product platelet yield was observed [Table 2]. Pearson's correlation test was done to assess this. A positive correlation was found, i.e., higher the predonation platelet count; higher is the product platelet yield. Guerrero-Rivera et al.[11] found a direct relation between the two parameters, and in addition, they report an inverse relationship between HB and platelet yield. Lasky et al.[22] found that platelet count was the main predictor of platelet yield.

Observation of all SDP donors for adverse reactions showed that only one had mild donor reaction that was mild bruising at the needle insertion site. Local reactions were also described in other two studies.[5],[23] The extracorporeal volume is the least on Cobe Spectra (131 ml), as compared to the other machines. Cobe needed the least amount of AC (in the present study mean 328.4 ml ACD used), hence fewer chances of donor reactions. This is similar to the findings of Benjamin et al. and Tendulkar andRajadhyaksha [18],[24] we did not get a single citrate reaction in all our donors in contrast to many studies which have shown citrate reactions.[25] This may be attributed to prophylactic administration of calcium tablet to donors (as per our own standard operating procedure). Many authors found that the administration of 2 g of calcium carbonate was associated with a statistically significant reduction in the severity of paresthesia.[26],[27] This simulates to that of our findings. Our study has shown adverse events to be 0.7% which makes it safer than whole blood donation which accounts for 2%–3% of adverse donor reactions.[28] Various evidence in the literature suggests that the frequency of reactions to apheresis donation is less than that seen in whole blood donation.[5],[29] In our study, 128 (94.8%) donors had yield more than 3 × 1011 per unit [Figure 2] and thus >94% of our SDP met AABB guidelines, and 100% of our products met European guidelines [30] (yield more than 2 × 1011).[10],[31] In comparison, only 41.5%, 66.1% of SDPs met AABB guidelines in other studies.[5],[32]

Various troubles were faced during the procedure. Spillage and RBC contamination were managed by changing the donor input, i.e. donor Hct value increased. In cases where there was no increment of CCM, the Hct value of donor is reduced in the apheresis machine. Low access pressure was most frequently faced problem during apheresis procedure, which was managed by adjusting the phlebotomy needle.

Recipient of SDP was variety categories of patients with thrombocytopenia. They included acute myeloid leukemia, acute lymphoid leukemia, chronic lymphoid leukemia, chronic myeloid leukemia, Ewing's sarcoma, multi organ dysfunction, sepsis, non-Hodgkins lymphoma, testicular cancer, lung cancer, carcinoma breast, dengue, etc. Mean increment of platelet count in patients was found to be 76,156 ± 3397/μl. Platelet increment following 1 SDP transfusion was good. It varied from 60,000/μl to 100,000/μl in 78 episodes, more than 100,000/μl in 21 cases, 30,000/μl to 60,000/μl in 25 times. In six cases, the increment was <30,000/μl and no increment seen in five cases. In these five cases, therapeutic benefit and clinical improvement were observed in the form of stoppage of bleeding with prevention of bleeding. Sometimes, patients do not achieve the optimal, predicted response because of alloimmunization and/or clinical factors such as fever, infection, disseminated intravascular coagulation, bleeding, concomitant use of medications or other conditions.[33] Our patients had splenomegaly which might have attributed to nonincrement of platelet due to increase platelet consumption. Patients having increment >80,000/μl were evaluated. It was found that they either got higher yield of SDP unit or they had low body mass index.

Patients well-tolerated SDP product when transfused. Only one transfusion reaction was reported, that was allergic reaction of mild variety, subsided with antihistamine. Not a single case of FNHTR was reported. This owes to leukoreduced products. No case of TRALI was reported (all our donors were male). Till date, limited data are available which date does not suggest a difference in TRALI risk between apheresis platelets and pooled whole blood derived platelets.[34] All of our SDP transfusions were group identical and special steps were taken to avoid clerical errors.


  Conclusion Top


Our study found that plateletpheresis procedure is very safe from donor point of view and SDP product is effective from recipient's point of view. By focusing on different aspects of plateletpheresis which has been enumerated in the present study, SDP should be introduced in tertiary care hospitals and should be advised in the thrombocytopenia patients requiring platelet transfusion for the better and effective management of the patients.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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McLeod BC, Price TH, Owen H, Ciavarella D, Sniecinski I, Randels MJ, et al. Frequency of immediate adverse effects associated with apheresis donation. Transfusion 1998;38:938-43.  Back to cited text no. 5
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