Blood donor haemovigilance in Yaoundé, Cameroon

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1 Transfusion Medicine ORIGINAL ARTICLE Blood donor haemovigilance in Yaoundé, Cameroon E. C. Nchinda, 1 C. T. Tagny 1,2 & D. Mbanya 1,2 1 Department of Hematology, Faculty of Medicine and Biomedical Sciences, University of Yaoundé I,and 2 Hematology & Transfusion Service, University Teaching Hospital, Yaoundé, Cameroon Received 14 December 2011; accepted for publication 24 April 2012 SUMMARY Background: Blood availability is an issue of concern in countries of sub-saharan Africa where both the demand and discard rates of blood are high. Although some degree of attention is paid when transfusion reactions occur in recipients, no information is available on donor reactions in this setting. Objectives: This study was carried out in order to obtain some data on adverse reactions (ARs) to blood donations. It would make it possible to monitor and improve the safety of the donation procedure, which constitutes a strategy towards increasing donor supply by encouraging first-time donors to return in the absence of any negative outcomes of donation. Methods: A hospital blood bank-based descriptive and prospective study was carried out to document ARs among 1034 blood donors from September 2010 to January A pre-structured data collection tool was used to record the signs and symptoms observed. Results: The ARs occurred at a rate of 2 8%. The most frequent reaction was hypotension which constituted 26 62% of all ARs. Haematomas represented 18 42% while weakness and dizziness were each noted in 13 16% of donors. There was no severe vasovagal reaction. Associated factors to vasovagal reactions were first-time donor status (P = 0 004), female sex (P = 0 01) and low body weight (P = 0 02). Conclusion: Our results suggest that blood donation is a relatively safe procedure in our context. The frequency is higher than studies from developed countries. The association of AR with first-time blood donation needs to be verified in a larger study. However, it could suggest another benefit of regular blood donation. Key words: adverse reactions, blood donor, Cameroon, haemovigilance. Correspondence: Dr Claude T. Tagny, Hematology & Transfusion Service, University Teaching Hospital, P.O. Box 4806, Yaoundé, Cameroon. Tel.: ; fax: ; tayouclaude@yahoo.fr Haemovigilance as defined by the International Haemovigilance Network is a set of surveillance procedures covering the whole transfusion chain, intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence. Blood safety continues to be a challenge in most developing countries where transfusion policies and legislations regulating this practice are mostly lacking, and where available not implemented. Furthermore, blood availability is an issue of concern in settings where the demand for blood is very high. According to the World Health Organisation (WHO), most blood is donated from developed countries, although most of this is consumed in the developing countries where only about 39% global blood donation occurs (WHO, 2004). Countries of sub-saharan Africa (SSA) also have a high discard rate of collected blood (Mbanya et al., 2003; Collenberg et al., 2006), further hampering blood supply. Safe blood begins with safe donations, but there is an absence of comprehensive donor recruitment programmes in most countries of SSA and blood banks thrive on family/replacement and paid donations with little focus on donor reactions. Family/replacement donors are donors who give blood to replace a unit of blood given to their relative who is a recipient. There are few haemovigilance programmes in our setting, but some degree of attention is paid when transfusion reactions occur in blood recipients (Mbanya et al., 2001; Arewa et al., 2009). However, no information is available on donor reactions and their outcome. In developed countries, adverse reactions (ARs) to blood donation are well documented. For example in 2006, Crocco and D Elia in Italy found a rate of 1 2%. Furthermore in 2006, nine American Red Cross regions reported 2 8% in the age group 20 years during whole blood donations (Eder et al., 2008a). Thus, this study was carried out in order to obtain some data on the profile of AR to blood donations in blood services of resources-limited areas. MATERIALS AND METHODS This was a descriptive and prospective study carried out from September 2010 to January 2011 at the Haematology and Transfusion Service of the Yaoundé University Teaching Hospital (UTH). Donors from this service and those obtained during 2012 The Authors First published online 27 May 2012 doi: /j x

2 258 E. C. Nchinda et al. mobile collections organised by the UTH as well as another structure, the Yaoundé Central Hospital, were recruited for this study. Following approval from the National Ethics Committee and from appropriate institutional authorities, a convenience sampling (not randomised) method was used for data collection: all blood donors who gave informed signed consent to participate in the study and were eligible to donate blood based on the criteria observed at the UTH, were systematically included during 5 months. All sessions of blood donation, mobile or not, were targeted. Prior to medical selection, all the donor candidates were informed on the selection criteria of blood donation and on the risk factors of transfusion transmitted infections. For every candidate, inclusioncriteria for the study included: age between 18 and 65 years, weight greater than or equal to 50 kg, last donation at least 3 months ago for men and 4 months for women, apparently good health status, blood pressure (BP) between 100/60 and 160/100 mmhg and temperature between 36 and 37 5 C. Exclusion criteria included: risk behaviour related to sexual habits, drug consumption, past medical history of infections, and cardiovascular, cerebral or pulmonary diseases. Haemoglobin level (hb) was checked before every donation. Hb level required for inclusion was at least 110 g/l. The percentage of discarded donors in the UTH was 13%. Baseline information was obtained from each donor including sociodemographic data, medical and transfusion history and physical examination data (BP, weight, respiratory rate and others). Each donor was then closely monitored during and after the donation process and all findings were recorded on their respective working sheets. Donors were invited to inform the research team of every AR occurring during the 8 days following their donation. Each donor recruited during mobile collection having AR was also invited to come to the hospital for appropriate treatment. The ARs occurring were classified as local reaction, mild vasovagal reaction and severe vasovagal reaction. AR was defined as an undesirable response in a donor that is associated with the collection of blood or blood components. Vasovagal reaction is defined as the simultaneous enhancement of the parasympathetic (vagal) tone and withdrawal of sympathetic tone resulting in a cardioinhibitory and a vasodepressor response usually caused by an external stimulus. Hypotension was defined as systolic BP less than 90 mmhg, independent of age and gender. Late AR was defined as AR occurring when the donor has left the blood bank, few hours after completion of donation. A mild vasovagal reaction was defined as a mild symptom reported by the donor and not necessarily observed by the phlebotomist during a few minutes and which did not need specific medical assistance (i.e. dizziness, weakness). A severe vasovagal reaction was defined as a symptom causing significant disability or incapacity following a complication of blood donation and persisting for a prolonged period (ISBT, 2008). Categorical analyses with two by two tables were carried out to determine any donor characteristic which might expose them to AR during or after blood donation. The different associated factors tested for vasovagal reactions were identified among the classical parameters registered before blood donation: age, gender, donation status, type of donor, low weight (<60 kg), low pre-donation BP, i.e. <100 mmhg of systolic BP and site of blood collection (hospital/blood bank or mobile collection). Chi-square test and Fisher s exact test for categorical analyses with two by two tables were used to examine the relationship between variables. Differences in proportions were evaluated using these same tests. With the confidence interval (CI) fixed at 95%, statistical significance was considered if P < RESULTS Blood donor profile A total of 1034 blood donors were included from all the study sites. Only 9% of blood donors were recruited from mobile site. Their mean age was 28 5 ± 8 years (18 65); predominantly the years age group constituted 41 49% of the study population. The median was 26 years. There were 193 female donors representing 18 7% of the total sample and 841 male donors (81 3%), giving a male/female ratio of 4 4:1. A proportion of 36 3% of donors had university level education, 58 2% had secondary level education while 5 4% had only a primary school level. The frequency of first-time donors was 60 9% (n = 630 donors). Family/replacement donors accounted for 86 4% (n = 893). More details are available in Table 1. ARs during blood donation All reactions were obtained from 29 blood donors giving a frequency of 2 8%. Classifying the AR, there were 8 local reactions, which were haematoma and paraesthesia (21 05%), and 30 mild vasovagal reactions (78 95%). A total of 38 signs and symptoms were observed during this study. The most frequent reaction was hypotension which constituted 26 32% of all AR and 1% of the total sample. The second most frequent was haematoma which represented 18 42% of AR, followed by weakness and dizziness (Table 2). Among the seven haematoma, six occurred during venipuncture and one during blood collection. Five donors presented with a combination of signs and symptoms, three had one symptom and one sign and two had one symptom and two signs. Given that there was not any severe reaction, none of the donors who presented an AR required hospitalisation. The majority of these donors were observed in the blood bank for the time duration necessary for the disorder to resolve. Of the 29 donors, 28 required observation which lasted between 15 and 30 min. There was one donor who had spontaneous recovery, not requiring particular attention after the process. The donation process was incomplete mainly due to complicated venipuncture or vasovagal reaction. The process was interrupted in only 24 1% of cases presenting an AR, the remaining cases occurred at the end or after blood collection. Associated factors Associated factors to vasovagal reactions were first-time donor status (P = 0 004), female sex (P = 0 01) and low body weight Transfusion Medicine, 2012, 22, The Authors

3 Blood donor haemovigilance in Yaoundé, Cameroon 259 Table 1. Profile of blood donors Family/replacement donor Voluntary non-remunerated blood donor Parameters of profile FTD n (%) RD n (%) FTD n (%) RD n (%) Age group (n = 429) 246 (57 3) 91 (21 2) 59 (13 8) 33 (7 7) (n = 356) 195 (54 7) 126 (35 3) 14 (4 0) 21 (6 0) (n = 201) 102 (50 7) 87 (43 3) 2 (0 9) 10 (5 1) >45 (n = 48) 12 (25 0) 34 (70 8) 0 (0) 1 (2 0) Total (n = 1034) 555(53 7) 338(32 7) 75 (7 2) 65 (6 3) Gender Male (n = 841) 461 (54 8) 283 (33 7) 47 (5 6) 50 (5 9) Female (n = 193) 99 (51 3) 47 (24 4) 30 (15 5) 17 (8 8) Total (n = 1034) 560 (54 1) 330(31 9) 77 (7 4) 67 (6 5) Level of education Primary (n = 56) 43 (77 8) 10 (17 8) 3 (4 4) 0 (0) Secondary (n = 602) 340 (56 5) 190 (31 5) 48 (8) 24 (4) University (n = 376) 152 (40 3) 152 (40 3) 36 (9 7) 36 (9 7) Total (n = 1034) 535 (51 7) 352 (34 0) 87 (8 4) 60 (5 8) FTD, First-time donor (never donated before); RD, repeat blood donor (donated blood at least once). Table 2. ARs observed during blood donation of 29 blood donors AR Frequency Percentage (%) Overall proportion (%) Hypotension (<90 mmhg systolic blood pressure) Haematoma Weakness Dizziness Sweating Restlessness Hyperventilation Paraesthesia Cold extremities Total (P = 0 02). Table 3 shows the different factors found. No associated factor to local reactions was found. DISCUSSION The mean age of the study population was 28 5 ± 8 years and the median 26 years. This shows that blood donors in Yaoundé are mainly young adults. This mean is similar to that found in other SSA countries (Rajab et al., 2005; Nébié et al., 2007). It is, however, lower than the mean age of European donors (Lefrère & Rouger, 2006). The selected subjects for donation were mainly male donors. This may be attributed to the small number of female candidates who spontaneously came to donate at the static blood collection site. Also, selection criteria such as hb level, weight cut-offs and reproductive functions of women sometimes made them ineligible. The dominance of family donors over voluntary and non-remunerated blood donation (VNRBD) Table 3. Associated factors to vasovagal reactions Factor Group Frequency (%) Pvalue Age <21 years years 2 04 Gender Male Female 4 69 Donation status First time Repeat 0 15 Weight <60 kg kg 1 78 Pre-donation BP Low No AR Collection site Blood bank (static) Mobile unit 4 55 persisted as evidenced in numerous studies done in SSA (Tapko et al., 2007; Tagny et al., 2009a,b). The level of education of donors was generally low. The proportion of benevolent donors seemed to increase as the level of education increased, while that of family donors reduced. Similarly, the proportion of repeat donors increased as the level of education increased. No study has clearly shown the relationship between education and willingness to blood donation but the link reported in this study made in a hospital-based blood bank suggests that better education could increase the proportion of regular VNRBD. An explanation given by some authors could be that educated people better understand the importance of donating blood, and are less influenced by misconception or unfounded fears reported in SSA setting (Olaiya et al., 2004). It also suggests that education is indispensable in amelioration of blood availability and safety in our setting. We decided not to fully analyse blood donor according to collection site because the proportion of blood donors from mobile collection was very small for any relevant conclusion The Authors Transfusion Medicine, 2012, 22,

4 260 E. C. Nchinda et al. However, we did compare AR according to collection site (mobile versus static). Reactions were predominantly vasovagal. Concerning local reaction, Tagny et al. (2011) reported lack of sufficient trained phlebotomists working in African blood services. One possible reason for the high frequency of local reaction (hematoma) may be the lack of training, even if this explanation needs specific analytic studies. The ARs identified during this study were all immediate. No late AR to blood donation was recorded, no donor returned to the centre with a complaint concerning donation. Eder et al. found that the most frequent complications in donors were signs and symptoms noticed before syncope (hypotension, dizziness and weakness) and small haematomas (Eder et al., 2008b). Most haematomas were due to complicated venipuncture. The restlessness of one blood donor during the blood collection could be the explanation of his haematoma. No severe AR was recorded. Interestingly, these reactions are very rare in other settings as well; Garozzo et al. (2010) found a frequency of 0 03% severe ARs. Another Italian study found only four donors (three males and one female, 0 2% of all those presenting an AR) who had severe disorders, including loss of consciousness and convulsive syncope from a sample of 4906 donors (Crocco & D Elia, 2007). The overall frequency of this study was slightly higher than that in studies carried out elsewhere. In 2006, Crocco and D Elia in Italy studied ARs during voluntary donation of blood. They foundarateof1 2% AR. Furthermore, Garozzo et al. foundar occurring in 0 58% of all donations (Garozzo et al., 2010). No data on these AR exist in SSA, to the best of our knowledge. Possible reasons for this relatively high frequency include inadequate selection of blood donors (Tagny et al., 2012). It could be possible that certain paid donors were untruthful in answering questions, making them falsely eligible. Also the predominance of first-time donors which is an associated factor and possibly related to fear from misconception in the African setting about blood donation could explain this frequency. The study showed that the strongest associated factor of vasovagal AR was donation status (P = 0 004). After young age, Eder et al. also found that first-time donation had the next strongest association with AR (95% CI, P 0 001) (Eder et al., 2008b). In addition to safety procured by repeat donors, this should be considered as another motive to put into place adequate measures to keep repeat donors as well as encourage first-time donors to return. Young age (considered in this study below 21 years) did not appear to be an associated factor although other studies showed age to be a strong predictor (Franchini et al., 2002; Tondon et al., 2008). This could be because the youngest donor included was 18 years old, whereas other studies included donors as young as 16. Local reactions were unpredictable. In our study, the occurrence of an AR did not greatly interfere with the blood donation process because most ARs occurred at the end of the process, when blood donation was complete. They were all benign and required a few rapid and essential interventions, followed by observation after the process. CONCLUSION The frequency of ARs to blood donation in our setting was 2 8%, which is higher than that in developed countries probably due to inadequate selection, inaccuracy of donors in answering questions and fear from lack of accurate understanding of blood donation. The most frequent reaction that occurred after blood donation was hypotension, which was asymptomatic in most cases. In our study, associated factors to vasovagal reactions in order of decreasing importance were first-time donor status, female sex and low body weight. These factors have not been shown to be dependent or not. Further studies are needed to clearly demonstrate that these associated factors are predictors or not or not. However, the implementation of blood donation policies with adequate selection criteria could minimise the risk of ARs. Education and information of the general population about the importance and safety of donating blood could help to eliminate the fear and misconception about blood donation in this setting. Blood bank personnel should closely monitor donor parameters notably BP before and after donation and quickly intervene when necessary. More attention could be paid when dealing with first-time donors, female donors and low weight donors. Our study suggests that regular donation should be promoted because it is possibly associated with less number of ARs. However, the association of AR with first-time blood donation needs to be verified in a larger study. It would make it possible to improve the safety of the donation procedure, which constitutes a strategy towards increasing donor supply by encouraging first-time donors to return. ACKNOWLEDGMENTS This study was designed by C. T. T., E. C. N. and D. M.; performed by E. C. N. and C. T. T.; written by E. C. N. and C. T. T. andfinallyrevisedbyc.t.t.andd.m. CONFLICT OF INTEREST The authors have no competing interests. REFERENCES Arewa, O.P., Akinola, N.O. & Salawu, L. (2009) Blood transfusion reactions; evaluation of 462 transfusions at a tertiary hospital in Nigeria. African Journal of Medicine and MedicalSciences, 38, Collenberg, E., Ouedraogo, T. & Ganame, J. (2006) Seroprevalence of six different viruses among pregnant women and blood donors in rural and urban Burkina Faso: a comparative analysis. Journal of Medical Virology, 78, Transfusion Medicine, 2012, 22, The Authors

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