Delayed adverse reactions in whole blood donors: Importance of active surveillance in identifying the missing gaps in the donor safety.

Background & objectives: The information available regarding delayed adverse donor reactions (D-ADRs) is limited. Proactive follow up of donors for delayed reactions is not done routinely. This study was undertaken to analyze frequency and type of D-ADRs in whole blood donors as also the contributory factors. Methods: In this prospective observational study, all eligible whole blood donors were contacted telephonically twice (24 h and 2 wks after donation) and asked about general health and ADR specific questions. The International Society of Blood Transfusion standard guidelines were used to categorize ADRs. Results: The ADR data of 3514 donors were analyzed in the study. D-ADRs were more common as compared to immediate delayed adverse donor reactions (I-ADRs) (13.7 vs. 2.9%, P<0.001). The most common D-ADRs were bruises (4.98%), fatigue or generalized weakness (4.24%) and sore arms (2.25%). D-ADRs were more common in first time donors as compared to the repeat blood donors (16.1 vs. 12.5%, P=0.002). Females were more prone to D-ADRs (17 vs. 13.6%). Localized D-ADRs were more frequent as compared to systemic D-ADRs (P<0.001). Repeat donors had a lower incidence of systemic D-ADRs (4.11% vs. 7.37%, P<0.001). Interpretation & conclusions: D-ADRs were more common than I-ADRs with a different profile. First time, female and young donors were more prone to D-ADRs. These categories need special care at the time of blood donation. Active follow up of blood donors should be done from time to time to strengthen donor safety.

The determinants of donor safety and product quality in optimization of apheresis granulocyte harvest: An experience from a tertiary care oncology centre in India.

Allogeneic granulocyte transfusions play a substantial role in treatment of lifethreatening neutropenia-associated infections in patients undergoing intensive chemotherapy and hematopoietic stem cell transplant. Granulocyte harvest by apheresis is considered a safe and effective method to obtain adequate therapeutic granulocyte dosage for clinical effectiveness. This study described the experiences associated with apheresis granulocyte harvest procedures in our tertiary care haemato-oncology centre. We have analysed the incidence of adverse events (AEs) with associated potential risk factors contributing to donor safety and improvement in product quality. Retrospective data of 131 healthy allogeneic donors who underwent granulocyte harvest from May 2016 to July 2020 were analyzed. AEs were observed in overall 29 procedures (22.13%), including 14.50% citrate reactions, 7.6% venous access-related reactions, and 1.52% vasovagal reactions. Older age (p = 0.012) and higher body mass index (p = 0.015) in donors were significant variables found associated with a higher incidence of AEs. There was no significant impact of AEs on granulocyte product yield (p = 0.41) with a median collection yield of 1.73 × 10 10 cells/ unit. In multivariate analysis, post-mobilization parameters like total leukocyte counts (p = 0.036), absolute neutrophil counts (p = 0.042), and platelet counts (p = 0.006) showed a positive correlation with higher product yield. All the donors successfully donated and tolerated granulocyte colony stimulating factor plus dexamethasone mobilization and granulocyte apheresis harvest without any serious AEs. Our study shows that optimal technical and procedural modifications during apheresis granulocyte harvest procedures can overcome the associated potential risks by providing donor safety and improving product quality.

Impact of the novel coronavirus disease and lockdown on the packed red blood cells inventory management: An experience from a tertiary care oncology center in Western India

ABSTRACT Introduction The novel coronavirus disease has disrupted blood transfusion services worldwide. Despite blood transfusion services taking several precautionary measures to minimize the risks of COVID-19 during blood donations, donors became anxious regarding the risk of the COVID-19 infection during the donation and the blood transfusion services was facing the inevitable hazard of blood shortage. Methods The study was conducted at a tertiary care oncology hospital-based blood transfusion services and included analysis of blood donations, packed red blood cell units requirements, and packed red blood cell inventory in the pre lockdown and lockdown phase. New COVID-19 standard operating procedures with enhanced safety guidelines and donor confidence-building measures were implemented at the blood transfusion services. Results The total number of average monthly blood donations decreased in lockdown but the decrease was not statistically significant (238.5 vs. 197.8, P = 0.391). The requisitions for the packed red blood cell cross-matches (722.5 vs. 329.0, P = 0.001) and the packed red blood cell utilization (176.5 vs. 103.3, P = 0.028) for the hospital patients also decreased significantly due to the lockdown. In the lockdown phase, an expressive number of packed red blood cell units were outdated due to the unprecedented fall in the number of patients. In the post-lockdown phase, the packed red blood cell inventory was optimized with decreased outdating via a comprehensive approach. A special emphasis was given to the in-house donations. A second partial lockdown also decreased the blood donations. Conclusion Confidence-building in blood donors and the resolution of logistical issues were crucial for the efficient packed red blood cell inventory management in the lockdown. Implementation of COVID-19 preventive measures helped in the blood donor and blood transfusion services staff safety.

The impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors.

BACKGROUND: Adverse donor events (ADEs) are usually mild and short-term with no sequelae, but may cause disinclination toward future donations. AIMS: To determine the impact of delayed ADEs (D-ADEs) in addition to immediate ADEs (I-ADEs) on the intention of future donations (IFDs) and to analyze the various associated factors. METHODS: ADEs were categorized following the ISBT working group on donor vigilance. Telephonic interviews of the donors were conducted 2 weeks after the whole blood (WB) and plateletpheresis donation to inquire about D-ADEs and IFDs. RESULTS: A total of 3514 WB and 531 plateletpheresis donors were included in the study. WB donors had an overall higher IFD as compared to plateletpheresis donors (89.53% vs 57.06%, P < .001). A higher IFD was observed in male WB donors as compared to female WB donors (89.95% vs 75%, P < .001). Repeat WB donors had a higher IFD as compared with first-time donors (93.66% vs 81.37%, P < .001). A total of 13.7% WB donors and 19.2% plateletpheresis donors reported D-ADEs. WB donors who experienced D-ADEs had a significantly lower IFD (78.38% vs 91.63%, P < .001) as compared with donors without any ADEs; a similar trend was observed in donors who experienced I-ADEs (69.90% vs 91.63%, P < .001). In WB donors, systemic D-ADEs such as fatigue had a more negative impact on IFDs as compared with localized D-ADEs such as bruises (63.93% vs 86.83%, P < .001). CONCLUSIONS: Both D-ADEs and I-ADEs negatively impact donors' intention to donate again. Systemic D-ADEs had a more negative impact on IFDs as compared with localized D-ADEs.

Impact of the novel coronavirus disease and lockdown on the packed red blood cells inventory management: An experience from a tertiary care oncology center in Western India.

INTRODUCTION: The novel coronavirus disease has disrupted blood transfusion services worldwide. Despite blood transfusion services taking several precautionary measures to minimize the risks of COVID-19 during blood donations, donors became anxious regarding the risk of the COVID-19 infection during the donation and the blood transfusion services was facing the inevitable hazard of blood shortage. METHODS: The study was conducted at a tertiary care oncology hospital-based blood transfusion services and included analysis of blood donations, packed red blood cell units requirements, and packed red blood cell inventory in the pre lockdown and lockdown phase. New COVID-19 standard operating procedures with enhanced safety guidelines and donor confidence-building measures were implemented at the blood transfusion services. RESULTS: The total number of average monthly blood donations decreased in lockdown but the decrease was not statistically significant (238.5 vs. 197.8, P = 0.391). The requisitions for the packed red blood cell cross-matches (722.5 vs. 329.0, P = 0.001) and the packed red blood cell utilization (176.5 vs. 103.3, P = 0.028) for the hospital patients also decreased significantly due to the lockdown. In the lockdown phase, an expressive number of packed red blood cell units were outdated due to the unprecedented fall in the number of patients. In the post-lockdown phase, the packed red blood cell inventory was optimized with decreased outdating via a comprehensive approach. A special emphasis was given to the in-house donations. A second partial lockdown also decreased the blood donations. CONCLUSION: Confidence-building in blood donors and the resolution of logistical issues were crucial for the efficient packed red blood cell inventory management in the lockdown. Implementation of COVID-19 preventive measures helped in the blood donor and blood transfusion services staff safety.

Comparative analysis of platelet concentrates prepared after two hours and overnight storage of buffy coat at room temperature.

INTRODUCTION: The overnight storage of the buffy coat (BC) at room temperature has logistic and operational advantages for the blood centre. The present study aimed to evaluate the impact of an overnight hold (stored) of BC at room temperature in comparison with the 2-hour hold (fresh) of buffy coats on the platelet concentrate (PC) characteristics. METHODS: A total of 60 BCs were included in the study, 30 PCs (fresh) were prepared after two hours holding time of the BCs and the other 30 PCs (stored) were prepared after the overnight BC storage at room temperature. The primary endpoint of PCs evaluation was the platelet yield, volume, pH, WBC count, RBC count, and platelet swirling in the PC and the secondary endpoints were glucose concentration, lactate, LDH, and sterility of the PCs. All the tests were performed on the day+1 of the blood collection. RESULTS: There was no difference concerning the volume, RBC count, and swirling between the two groups (P>0.05). The PCs from the fresh BC had higher pH and glucose concentration (P<0.05). On the other hand, the overnight hold of BC produced higher platelet counts, WBC counts, lactate, and LDH levels (P<0.05). All the 60 PCs did not record any bacterial growth on the culture media for the sterility results. CONCLUSION: The overnight hold of BC produces a higher platelet yield with higher storage lesions. This may also allow better supervision, ensuring better quality control.

Challenges in platelet inventory management at a tertiary care oncology center during the novel coronavirus disease (COVID-19) pandemic lockdown in India.

The novel coronavirus disease (COVID-19) has been declared a pandemic by the world health organization and to limit the spread of the disease, many countries in the world, including India, had enforced a lockdown. Despite no restriction over the platelet donation activities, plateletpheresis donors became apprehensive regarding the possible risk of spread of the COVID-19 during the platelet donation and in the hospital premises. Many of them started hesitating for platelet donations. With this, the blood center started having an acute shortage of platelets. Various confidence-building steps were implemented by the blood center to promote voluntary plateletpheresis. The blood center staff and individual donors were educated to prevent the spread of COVID-19. The donor organizations and plateletpheresis donors were informed about the steps to be taken by the blood center during the donation and necessary steps for the prevention of the possible spread of COVID-19. With the help of these measures, the confidence of the individual platelet donors and the donor organizations was restored in the blood center and regular plateletpheresis was continued. These measures may also be useful to other blood centers in the COVID-19 pandemic and this experience may be useful if a similar pandemic lockdown happens in the future.

Organization of the outdoor blood donation drives amid novel coronavirus pandemic and national lockdown: An experience from a tertiary care oncology institution in India.

The conduct of blood donation drives became difficult amid novel coronavirus disease pandemic and national lockdown. Despite no restriction for the outdoor blood donation drives, voluntary blood donor organizations (VBDOs) and individual donors became apprehensive regarding the possible risk of spread of the infection during blood donation. Various confidence-building measures were taken to decrease this hesitation. Numerous preventive measures were taken at the blood bank and at the donation venue to limit the possible risk of the spread of infection. With the help of these measures, the confidence of the individual blood donors and the VBDOs was restored and multiple blood drives were organized.

Delayed adverse events in male plateletpheresis donors: Initial insights on donor safety.

BACKGROUND: Minimal information is available regarding delayed adverse donor events (D-ADEs) in plateletpheresis donors. Proactive follow up of donors for D-ADEs is not done routinely by BTS. The aim of this study was to analyze frequency and type of D-ADEs and its correlation with contributory factors if any. METHODS: In this prospective observational study all eligible donors were contacted by telephone twice and asked about general wellbeing and questions specific to adverse donor events (ADEs). Donors were called at 24 hours and 2 weeks after donation. The ADEs were categorized in accordance with the International Society of Blood Transfusion standard guidelines. RESULTS: A total of 531 donors were analyzed in the study. D-ADEs were more common as compared to immediate ADEs (I-ADEs) (19.21% vs 5.46%, P < .0001). The most common D-ADEs were bruises (7.34%) and sore arms (3.58%). Localized D-ADEs in form of bruise and hematomas were more frequent as compared to systemic D-ADEs like fatigue and vaso-vagal reactions (16.01% vs 3.20% P < .0001). Repeat donors had a lower incidence of systemic D-ADEs (1.61% vs 6.96%, P = .001). Donors with weight ≤75 kg and platelet count ≤230 × 103 µL were more prone to systemic D-ADEs (P < .05). Citrate toxicity was more common in donors with weight ≤ 75 kg (P = .002). CONCLUSIONS: Plateletpheresis procedures are relatively safer without any sequelae. D-ADEs are more common than I-ADEs. Localized D-ADEs are more frequent than systemic D-ADEs. First-time donors are more prone to D-ADEs than repeat donors.

First Indian initiative for preparation of low-titer group "O" single-donor platelets with platelet additive solution.

BACKGROUND: Guidelines recommend ABO-identical platelet (PLT) transfusions. Hemolytic reactions after a minor ABO-incompatible PLT transfusion have escalated due to single-donor platelets (SDP) containing ABO-incompatible plasma. Avoiding such events by examining titers or performing plasma reduction is cumbersome. The introduction of platelet additive solutions (PAS) has enabled to reduce these reactions by avoiding passive transfer of isoagglutinin. Our aim was to study antibody titers (anti-A, anti-B) in "O" SDP by adding PAS at source and the quality parameters with reference to viability, morphology, and metabolism. MATERIALS AND METHODS: Group "O" SDP (n = 50) were prepared on a standard cell separator. PAS in a ratio of 70:30 (PAS: plasma) was added at source under sterile conditions (study arm). The units were studied on day of collection (day 0) and day 4 and compared with SDP containing 100% plasma (control arm). A titer study was performed after PAS addition. RESULTS: In the study group, the median antibody titers (anti-A, anti-B) reduced from 128 to16, post-PAS addition (P < 0.001). Morphology scores were superior in PAS platelet concentrates (P < 0.001). Metabolic parameters pO2 and pCO2 were similar in the two arms signifying good unit storage and stable oxygen consumption (P > 0.05). Lactate levels, glucose consumption rate, and lactate production rates were significantly low in study arm showing the advantage of PAS. CONCLUSION: O group SDPs can be prepared with PAS and the beneficial effects were significant with respect to antibody titers. Quality parameters were well maintained. Availability of PAS units has benefitted patients.

Therapeutic leukocyte reduction for acute and chronic myeloid leukemias: A 4-year experience from an oncology center in India.

INTRODUCTION: Hyperleukocytosis (HL) and leukostasis seen in myeloid leukemias are a medical emergency. We present a case series of ten such patients in a 4-year period. Sixteen therapeutic leukocyte reduction (TLR) were done in ten cases along with other supportive measures. The American Society for Apheresis supports the routine implementation of TLR in cases of HL secondary to myeloid leukemias with signs of leukostasis. MATERIALS AND METHODS: The procedures were performed on the intermittent flow cell separator after discussion with the treating physician about patient's condition. Clinical, demographic, analytical, and technical variables were reviewed retrospectively and the patients were followed up at the end of 4 years. Descriptive analysis was performed for all variables, and relationships between quantitative variables and categorical variables were determined by applying the Student's t-test. RESULTS: The mean age of presentation was 34 years. Priapism was the most common symptom followed by respiratory distress and neurological disturbances. After an average of 1.6 TLR procedures, the mean leukocyte count reduction achieved was 39.9% along with symptomatic relief. The mean survival at 4-year follow-up was 12.8 months and the overall mortality was 20%. Acute myeloid leukemia patients presented with lower mean platelet counts compared to chronic myeloid leukemia patients; however, the platelet loss in the final product was minimized. CONCLUSION: TLR is a safe and effective therapy for leukoreduction in hematological malignancies in our experience.