|Year : 2021 | Volume
| Issue : 2 | Page : 135-140
Adverse reactions to the donation of platelet by apheresis and related factors in a tertiary level care blood center
Vadivel Arunachalam, Rajendra Kulkarni, Abhishekh Basavarajegowda
Department of Transfusion Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India
|Date of Submission||21-Jan-2021|
|Date of Decision||08-Sep-2021|
|Date of Acceptance||20-Sep-2021|
|Date of Web Publication||30-Nov-2021|
Dr. Abhishekh Basavarajegowda
Department of Transfusion Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Source of Support: None, Conflict of Interest: None
Background and Objectives: Although blood donation by apheresis is very safe, it is essential to identify the adverse reactions that happen and address the factors related to it so as to improve the donation experience both to the donors and the center accepting donations. This study was designed to assess the frequency of adverse reaction in donors undergoing apheresis for platelet donation and delineate the factors associated with the occurrence of such adverse donor reactions, if any. Methodology: This was an analytical retrospective study on the available data of all the donors who donated single-donor apheretic platelets in our blood center from January 2014 to October 2018. Results: The overall donor reaction rate was 8.3%, with the majority (4.7%) being a local reaction in the form of a hematoma. The other 3.6% were systemic reactions, among which 2.1% were citrate reactions and 1.5% vasovagal reactions (VVRs). The variables associated with a VVR were body weight <75 kg and diastolic blood pressure of <70 mmHg, whereas for citrate-related toxicities, it was the duration of the procedure and the amount of anticoagulant used. 4.7% of them were localized reactions in the form of the hematoma, which were more common in first-time donors. Conclusion: Adverse donor reactions to plateletpheresis are notable (8.3%) but generally mild. Auditing them to look for factors associated helps us review the policies and improve competencies among the staff to improve the safety of donors.
Keywords: Adverse reactions, citrate reactions, hematoma, plateletpheresis, vasovagal reactions
|How to cite this article:|
Arunachalam V, Kulkarni R, Basavarajegowda A. Adverse reactions to the donation of platelet by apheresis and related factors in a tertiary level care blood center. Glob J Transfus Med 2021;6:135-40
|How to cite this URL:|
Arunachalam V, Kulkarni R, Basavarajegowda A. Adverse reactions to the donation of platelet by apheresis and related factors in a tertiary level care blood center. Glob J Transfus Med [serial online] 2021 [cited 2022 May 26];6:135-40. Available from: https://www.gjtmonline.com/text.asp?2021/6/2/135/331614
| Introduction|| |
The modern apheresis machine allows collecting multiple blood components from a single donor in various combinations. The motivation to collect more than one product from a single donor comes from decreasing the donor pool and minimizing the risk of alloimmunization from multiple donors in the case of whole blood-derived component usage. The therapeutic dose of a component can be collected from a single donor with less volume of the product when compared to whole blood-derived components. These facts motivate both the blood collection center and the physician to shift toward the apheresis method of component collection.,,
The literature suggests that the prevalence of adverse donor reactions is wide from <2% and up to 15%.,,, Any adverse reaction in an apheresis donor will make him/her unfit or leave him/her demotivated for future donations. Hence, it is necessary to identify the frequency of such reactions and the factors associated with them. Local geographical factors are also known to play a significant role in it. This will help us to take necessary preventive steps to avoid the same for permanent donor retention.
Aims and objectives
This study was intended to observe the frequency of adverse donor reaction in apheresis blood donors and study the factors associated with such reactions. This will help develop strategies to prevent and improve the apheresis experience for permanent donor retention.
| Methodology|| |
This was a descriptive study involving plateletpheresis donors who had undergone the apheresis platelet donation procedure in a tertiary care blood center between January 1, 2014, and October 1, 2018, and retrospective data were collected from the apheresis donor register.
All fit apheresis donors who donated successfully or developed adverse donor reactions during the apheresis procedure, up to 30 min post-donation, and if donor reports any reaction within 7 days after the procedure, were included. All the donor reactions were defined as per the prevalent standards described in the guidance document from the Hemovigilance Program of India. The reactions were observed and recorded by the resident doctor of the apheresis section.
Sample size estimation
Assuming alpha error of 5% of the expected proportion of adverse donor reaction among apheresis donors as 2% with an absolute precision of 1%, a total of 819 apheresis donors were required for the study. A total of 200–300 apheresis donors attend our hospital blood center every year. Hence, a total of 1145 donors who donated were registered for the study.
The institutional ethics committee approved the study vide infra letter no. JIP/IEC/2016/1133 dated March 18, 2017, in the category of less than minimal risk. Informed consent was waived off as this was a record-based study with data collected confidentially and in a de-identified manner.
Data were collected from the hospital admission case sheet of donors treated for adverse donor reaction daily. All details of adverse donor reaction were collected in a structured pro forma. The flow of apheresis donors is shown in [Figure 1].
Statistical data analysis
All collected data were entered in a Microsoft Excel spreadsheet, and SPSS for Windows version 20 (SPSS IBM Corp. Ltd. Armonk, NY) was used for analysis. The distribution of data on categorical variables such as donation status, vein caliber, previous reaction to donation, and admitted anxiety was expressed as frequency and percentages. The continuous data, such as age, calculated total blood volume, blood pressure (BP), and time of collection, were expressed as mean with standard error of the mean. The association of continuous variable mentioned above with donor reactions was carried out by an independent Student's t-test. The factors independently associated with the donor reaction were explored by using logistic regression analysis. All statistical analysis was carried out at a 5% level of significance.
| Results|| |
A total of 1145 donors were recruited, among which 507 were first-time donors and 638 were repeat donors. The total reaction rate was 8.3%, with local reactions being 4.7% in the form of the hematoma. The break of the adverse reactions and events is summarized in [Table 1] and [Table 2], respectively.
Hematoma occurred with increased frequency among first-time donors (6.1%) compared to repeat donors (3.5%), and this was statistically significant with a P value of. 004. The rate of occurrence of vasovagal reactions (VVRs) among first-time and repeat donors was found to be 1.77% and 1.25%, respectively. Only one of the donors who had a VVR has had a history of previous VVR. Only one of the donors had reported anxiousness and fear of needle among those who had a VVR. The sociodemographic characteristics of the donors who reacted are compared in [Table 3]. Among 639 repeat donors, 531 (46.3%) were apheresis repeat donors, and 108 (9.4%) had donated whole blood before. The biophysical profile of the donors is presented in [Table 4]. Ninety-nine percent (1134) of the donors had something to eat ½ h before donation. The remaining 1% of the donors had food at least 2 h before donation. The majority (99%) of donors had also reported having had adequate sleep. Most of the donors, 1140 (99%), had a waiting period of about 15 min, and 5 (1%) donors had a waiting time of 15–30 min. All the procedures were started within 30 min. The mean hematocrit of the donors was found to be 44.68 ± 3.26. The mean platelet count was 2.75 lakh/cmm ± 47,920 thousand/cmm. The relative risk of developing a VVR was 0.12 (95% confidence interval [CI], 0.03–0.53), and that of citrate reaction was 0.31 times (95% CI, 0.12–0.76) in donors with a weight of more than 75 kg when compared to those with <75 kg.
|Table 4: Biophysical characteristics of the donors who underwent plateletpheresis|
Click here to view
The relative risk of developing a VVR was 2.93 (95% CI, 1.07–8.03) times, and that of citrate reaction was 3.27 times (95% CI, 1.41–7.58) in donors with a diastolic BP of <70 mmHg when compared to those with more than 70 mmHg.
The procedural variables are summarized in [Table 5]. One of the donors who had a citrate toxicity-associated reaction had a previous history of citrate reaction. The mean volume of blood volume processed in donors who had citrate-associated reactions was 3517 ml compared to the mean volume of 3432 ml in donors who did not react. Whenever the procedure required the use of more than 350 ml of anticoagulant-citrate-dextrose (ACD), the odds of developing a citrate reaction was 1.25 times against when <350 ml of ACD was used. There was no statistically significant difference in the incidence of reactions among the type of equipment used. It was almost similar with regard to citrate reaction (2.2% in Haemonetics vs. 2.1% in Trima Accel). With regard to VVR, it was 0.7% in Haemonetics and 1.6% in Trima Accel.
|Table 5: Comparison of procedural variables in donors with reaction and not|
Click here to view
| Discussion|| |
In tertiary care hospitals, the use of apheresis products is increasing in treating malignancies, organ transplants, cardiac surgeries, etc. This has been aided mainly by an increase in the voluntary donor pool. Such donors have to be cared for and motivated to retain them permanently for future apheresis procedures.
In our study, the donor reaction rate reported was 8.3%. Most of the studies reported from various centers in India have reported around this value. A study from Western India has reported as low as 2.7%, whereas the one from Eastern India has reported as high as 19.43%., The comparison of the incidence of adverse reaction rates from various parts of the country is summarized in [Table 6].,,,,,,,
|Table 6: The reported incidence of donor reactions in plateletpheresis among various studies in India|
Click here to view
As seen with whole blood donation, apheresis donations also have very few risks or complications. The complications specific to apheresis donation are different in type, severity, and management. Understanding the factors that cause them will help us prevent them and aid in donor retention with a continuous pool of apheresis donors, which is required for apheresis donations. Although both whole and apheresis donations are safe, specific preventive steps have to be taken to avoid adverse reactions like hypercalcemic effects of citrate toxicity which can be prevented with calcium supplementation before the procedure.
Citrate used as the primary anticoagulant in donor apheresis procedures exerts its effect from its ability to chelate calcium ions resulting in the calcium ions being unavailable for coagulation cascade to set in. Despite compensatory mechanisms, its infusion can sometimes decrease ionized calcium levels to a point where symptoms develop in the donor.
VVRs result from an increased parasympathetic activity over and above that counteract the sympathetic activity coupled with the transient hypotension that results from extracorporeal blood that includes the donated product and that in the circuit. Factors that have been associated with VVRs donors include age, weight, first-time donation, and cooperation/engagement by the collection staff.,,
Among the notable sociodemographic factors though not statistically significant, donor age of 31–40 was protective compared to ages either more than 40 or <30, especially for VVR.
Gender is a risk factor, with females being more susceptible to donation-associated reactions than males. The number of female donors was too less in our study to compare or comment on the association of reactions with gender so as with the donation type, i.e. voluntary or replacement.
Weight and diastolic BP were two factors that were associated with lesser reactions and were statistically significant as well. Weight more than 75 kg was protective against VVRs for the donors. Diastolic BP of <70 was a statistically significant risk factor for developing donor reaction. Diastolic BP is not influenced by physiological activities and suggests a chronic state of the donor biophysique, and hence, a lower value would be more influential on causing VVR. The diastolic BP reflects peripheral vascular resistance, which is very important for venous return. Decreased venous return is a critical cause contributing to a VVR.
Depending on the extracorporeal volumes (ECVs) of the equipment used, the donor reactions may vary with the ones with higher ECV causing more reactions. The ECV of Haemonetics is up to 360 ml, whereas that of Trima Accel is 196 ml. However, our donors, most of them being more than 60 kg, maybe less of an issue as the 10% blood volume is more than 400 ml. Factors that have been found to influence the rate of citrate reactions in donor and therapeutic apheresis are hyperventilation leading to alkalosis, anticoagulant solution type, the amount used, infusion rate and serum albumin level of the donor prior to the start of the collection procedure. It has also been reported that machines performing intermittent flow procedures like Haemonetics have a greater frequency of citrate reactions, as there is a higher rate of citrate infusion as compared to the equipment performing continuous apheresis procedures like Trima Accel or COBE Spectra.
Hematomas usually result from an improper phlebotomy technique by inexperienced or failure to secure the needle properly throughout the procedure leading to movement of the needle, causing bruises and extravasation. Ours being a teaching institute, the residents and the phlebotomy technicians are rotated, with a new one coming every month. This could be the reason for a relatively higher incidence of hematomas. Our study also showed that the incidence was almost twice as common in first-time donors than the repeat donors. This is probably because the repeat donors usually help in the vein selection by pointing out to the vein, resulting in a previous successful donation.
Limitations of the study
The limitation of the study is that being a retrospective study missing data would have partly affected the study results. As ours is a teaching hospital, with resident doctors being rotated monthly, this could have caused a slightly increased number of hematomas because of variation in techniques. Long-term adverse reactions were not studied. A long-term study of adverse donor complications helps us take necessary preventive steps and corrective management of such complications.
| Conclusion|| |
A voluntary apheresis donor registry should be maintained and updated with repeat voluntary donors to prevent adverse donor reactions. Other donors should be motivated to be enrolled as voluntary donors. This will go a long way in helping to have a constant pool of safe apheresis donors.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Moog R. Implementation of concurrent red blood cell and platelet collection by apheresis in a university haemapheresis unit. Transfus Med 2004;14:145-50.
Picker SM, Radojska SM, Gathof BS. Evaluation of concurrent collection of in-line filtered platelets and packed red blood cells by multicomponent apheresis with three last-generation apparatuses. Vox Sang 2006;91:47-55.
Kurahashi M, Ogawa Y. Feasibility study on donor apheresis red cell and platelet simultaneous collection for blood center routine use. Ther Apher 1999;3:307-9.
Philip J, Sarkar RS, Pathak A. Adverse events associated with apheresis procedures: Incidence and relative frequency. Asian J Transfus Sci 2013;7:37-41.
] [Full text]
Patidar GK, Sharma RR, Marwaha N. Frequency of adverse events in plateletpheresis donors in regional transfusion centre in North India. Transfus Apher Sci 2013;49:244-8.
Biswas D, Mukherjee K, Chakrabarty D, Bhattacharya P, Mukherjee S. Incidence and analysis of blood donor adverse reactions – An opportunity to establish a donor vigilance programme at an institution in Eastern India. ISBT Sci Ser 2020;15:243-52.
Arora D, Garg K, Kaushik A, Sharma R, Rawat DS, Mandal AK. A retrospective analysis of apheresis donor deferral and adverse reactions at a tertiary care centre in India. J Clin Diagn Res 2016;10:C22-4.
Despotis GJ, Goodnough LT, Dynis M, Baorto D, Spitznagel E. Adverse events in platelet apheresis donors: A multivariate analysis in a hospital-based program. Vox Sang 1999;77:24-32.
Winters JL. Complications of donor apheresis. J Clin Apher 2006;21:132-41.
Solanki A, Katharia R, Singh A, Chauhan A, Chandra T, Sonker A, et al
. Prevalence and predictors of adverse reactions in plateletpheresis donors with the perspective of donor safety in a tertiary care hospital of Northern India. Asian J Transfus Sci 2020;14:44-8. [Full text]
Dogra K, Fulzele P, Rout D, Chaurasia R, Coshic P, Chatterjee K. Adverse events during apheresis procedures: Audit at a tertiary hospital. Indian J Hematol Blood Transfus 2017;33:106-8.
Khajuria K, Sawhney V, Sharma R, et al
. Adverse donor reaction during and after plateletpheresis in a tertiary care centre. Int J Res Med Sci 2017;5:1221.
Kumawat V, Goyal M, Marimuthu P. Analysis of donor safety in high yield plateletpheresis procedures: An experience from tertiary care hospital in south India. Indian J Hematol Blood Transfus 2020;36:542-9.
Strauss RG. Mechanisms of adverse effects during hemapheresis. J Clin Apher 1996;11:160-4.
Newman BH. Donor reactions and injuries from whole blood donation. Transfus Med Rev 1997;11:64-75.
Tomita T, Takayanagi M, Kiwada K, Mieda A, Takahashi C, Hata T. Vasovagal reactions in apheresis donors. Transfusion 2002;42:1561-6.
Raphan T, Cohen B, Xiang Y, Yakushin SB. A model of blood pressure, heart rate, and vaso-vagal responses produced by vestibulo-sympathetic activation. Front Neurosci 2016;10:96.
Burgstaler EA. Current Instrumentation for Apheresis. In: McLeod BC, Szczepiorkowski ZM, Weinstein R, Winters JL, editors. Apheresis - Principles and Practice. 3rd
ed. Bethesda: AABB Press; 2010. p. 71-109.
Anderson CM. Selection and care of apheresis donors. In: McLeod BC, Szczepiorkowski ZM, Weinstein R, WJ, editors. Apheresis: Principles and Practice. 3rd
ed. Bethesda: AABB Press; 2010. p. 111-23.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]