A rare vascular injury in a blood donor after whole blood donation.

BACKGROUND: Blood donation is a safe process though reactions may still occur. We describe a rare vascular complication in a frequent donor, with improvements in the collection process aimed at avoiding future events. METHODS: A 63-year-old woman presented with local pain and an apparent collection in the left arm 8 days after donation. Duplex ultrasound identified a superficial liquid collection and signs of arteriovenous fistula (AVF) between the cubital vein and an arterial branch. A computed tomography (CT)-angio performed 1 day after ultrasound did not identify signs of AVF, followed by a new duplex which confirmed CT-angio findings. It was assumed that a traumatic AVF evolved with spontaneous thrombosis. In the early follow-up (18 days), a progressive regression of hematoma was observed without any sequelae. RESULTS: Investigation showed a faster whole blood bag collection time (3 min; normal: 5-9 min), and the processed packed red blood cell had a brighter red color than usual. The donor reported local bleeding after needle withdrawal, not observed in previous donations and a bruise forming on the same day. No arterial puncture (AP) was noticed by the collection staff during the procedure. The staff was retrained and actions were taken focusing on more active surveillance of late reactions, highlighting the importance of post-donation information by the donors, regardless of any adverse reaction observed, to detect late complications. CONCLUSION: We described an uncommon AP in a donor that was not identified, leading to an AVF that spontaneously thrombosed.

Haemovigilance resources available for everyone: A report from the International Haemovigilance Tools Collaborative Project.

BACKGROUND AND OBJECTIVES: Haemovigilance systems are intended to collect and analyse data, and report findings relating to transfusion complications, such as blood product safety, procedural incidents, and adverse reactions in donors and patients. A common problem among developing haemovigilance programs is the lack of resources and tools available to countries striving to establish or enhance their haemovigilance system. MATERIALS AND METHODS: World Health Organization, in collaboration with International Society for Blood Transfusion (ISBT), International Haemovigilance Network and other haemovigilance experts embarked on a Haemovigilance Tools Project to collect and provide materials and resources to assist with the stepwise implementation of haemovigilance. RESULTS AND CONCLUSIONS: Resources are housed as a virtual compendium on the ISBT website under the Haemovigilance Working Party. These are managed by a subcommittee of the Working Party and are freely available and downloadable to all without requiring ISBT membership.

A national surveillance system for continuous monitoring of blood transfusion safety: German haemovigilance data.

BACKGROUND AND OBJECTIVES: Haemovigilance (HV) systems aim to improve transfusion outcomes in patients and donor safety. An important question for blood regulators is how to ensure an effective HV system. MATERIALS AND METHODS: We retrospectively analysed the HV reports submitted to Paul-Ehrlich-Institut over the last two decades. RESULTS: Between 2011 and 2020, 50.86 million units of blood components were used, and 8931 suspected serious donor and recipient adverse reactions (SARs), 874 serious adverse events (SAEs) and 12,073 donor look-backs were reported. Following implementation of specific risk-minimization measures (RMMs) between 2000 and 2010, SAR reporting rates decreased for transfusion-transmitted viral infections (TTVIs), transfusion-related acute lung injury (TRALI) and transfusion-transmitted bacterial infections (TTBIs), while increasing for other serious adverse transfusion reactions. Within this decade, the overall blood component use decreased. CONCLUSION: Long-term data collection forms the basis to establish trends and changes in reporting and to evaluate the effect of RMM. Standardized criteria for reaction types, seriousness and imputability assessments and availability of a denominator are important elements. Central data collection and independent assessment allow for monitoring HV data in a nationwide context over time. Stakeholder involvement and transparent feedback on the benefit of RMM will help to achieve the objectives of HV.

Blood transfusion dynamics in Colombia: Unveiling patterns, reactions and survival rates in multitransfused patients.

BACKGROUND AND OBJECTIVES: There is no consensus on a universally accepted threshold to categorize a patient as multitransfused. In 2019, Colombia established the definition of a multitransfused patient as someone who has received six or more blood components, irrespective of the time frame. This study aims to delineate the characteristics, adverse transfusion reactions (ATRs, definitions according to the International Society of Blood Transfusion [ISBT]) and survival rates in this population. MATERIALS AND METHODS: We performed an analysis from the data of all institutions engaged in blood component transfusions at the national level who notified events to the National Information System of Haemovigilance (SIHEVI-INS), from January 2018 to December 2022. The selection criteria focused on individuals who not only exhibited ATRs but also received six or more blood components. RESULTS: Among the 1,784,428 patients who received 6,637,271 blood components, an average of 3.7 components per patient was noted. Concurrently, 8378 ATRs were reported (12.6 ATRs/10,000 transfused components). Within this cohort, 691 patients met the criteria for multitransfusion. Predominantly women (51.8%), these individuals received between 6 and 14 blood components. Out of the 691 multitransfused individuals who experienced ATR, 541 had an allergic reaction. Conversely, out of the 6479 non-multitransfused individuals who experienced ATR, 3835 had an allergic reaction (odds ratio: 2.49, 95% confidence interval: 2.06-3.0). Notably, 271 multitransfused individuals (39.2%) were documented as deceased, with 76% succumbing within 12 months of encountering their most recent ATR. CONCLUSION: Multitransfused individuals in Colombia, being a high-risk group, exhibit a heightened susceptibility to allergic reactions, surpassing the frequency observed in other transfusion populations. This underscores the necessity for tailored medical care specific to this group.

Haemolytic transfusion reactions caused by non-ABO red cell antibodies reported to the Norwegian Haemovigilance System 2004-2020.

BACKGROUND AND OBJECTIVES: The aim of this study was to analyse the reports received in the Norwegian Haemovigilance System from 2004 to 2020 on acute and delayed haemolytic transfusion reactions caused by non-ABO red cell antibodies. MATERIALS AND METHODS: Antibody specificity, clinical symptoms and outcomes were included when available. RESULTS: After transfusion of 3.7 million red cell concentrates, reports on 78 cases of haemolytic transfusion reactions caused by non-ABO red cell antibodies were received, corresponding to an incidence of 1 in 47,000 transfused red cell concentrates. There were 30 acute and 48 delayed haemolytic transfusion reactions. A total of 113 red cell antibodies were found: 82 alloantibodies, 6 autoantibodies and 25 cases where the antibody specificity could not be determined. Two fatalities occurred: one caused by anti-Wra and one caused by an unidentified red cell antibody. The most frequently reported antibody specificities were those in the Rh and Kidd blood group systems, representing 24% and 14%, respectively, of all the antibodies identified. In six cases, errors occurred, leading to the issuing of blood units without the required phenotype match. CONCLUSIONS: Despite the possible underreporting, the low number of serious haemolytic transfusion reactions reflects an adequate pre-transfusion practice by the Norwegian blood banks.

Reactions to serum eye drops-New Zealand experience and review of the literature.

BACKGROUND: Serum eye drops (SED) are used to treat ocular surface disease. Reactions to SED are poorly documented. METHODS: We present our experience of self-reported reactions in New Zealand to SED (25%; autologous, allogeneic, or both) between 2003 and 2023, and a focused review of the literature. RESULTS: In total, 1067 patients received SED treatment (562 autologous, 318 allogeneic, and 187 both). Three (0.5% of those treated with allogeneic SED) reported reactions. All appeared to be allergic. All were associated with allogeneic SED. We have information on two patients: one had an eye reaction; in the other, the gastrointestinal tract was involved. The literature contains few reports of reactions to SED. They have involved both autologous and allogeneic SED, and various SED concentrations. None appears to have been severe. Notably, no eye or systemic infections have been reported. CONCLUSIONS: Information on the types and frequencies of reactions to SED is poor. This may be due to: serum being less likely to cause reactions; eyes being resistant to reactions; reactions being rare, and insufficient use of SED having occurred; under-reporting related to SED use at home and reactions being mild. More robust monitoring for reactions to SED is needed.

Suspected adverse reactions reported for blood, blood components, and blood products in VigiBase.

INTRODUCTION: Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized reports of adverse reactions for all blood products. STUDY DESIGN AND METHODS: ICSRs involving blood products as the suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms and the International Society of Blood Transfusion haemovigilance definitions were used to stratify adverse reactions. Descriptive statistics were used to characterize ICSR demographics. RESULTS: A total of 111,033 ICSRs containing 577,577 suspected adverse reactions with 6152 MedDRA preferred terms were reported for 34 blood products. There were 12,153 (10.9%) reports for blood components, 98,135 (88.4%) reports for plasma-derived medicines, and 745 (0.7%) reports for recombinant products. The majority of reports (21.0% and 19.7%, respectively) were from patients aged 45-64 and over 65 years. The Americas contributed the most ICSRs (49.7%). Top reported suspected adverse reactions were for the following MedDRA preferred terms: headache (3.5%), pyrexia (2.8%), chills (2.8%), dyspnoea (1.8%), and nausea (1.8%). CONCLUSION: VigiBase already has a large number of reports on blood products. When compared to other existing haemovigilance databases, our study found reports from a broader range of countries and reporters. This may provide us with new perspectives, but for VigiBase to reach its full potential in haemovigilance some alterations in what is captured in reports are required.

A Danish national, multicentre evaluation of the new donor vigilance system among different staff groups.

BACKGROUND AND OBJECTIVES: Two years after implementing a new national donor vigilance system, the Danish Haemovigilance Committee conducted a nationwide survey to evaluate the implementation among different staff groups. We present the results here. MATERIALS AND METHODS: The study was designed as an anonymous online survey to evaluate the satisfaction with the new registration, understanding of the parameters used and the user-friendliness. The REDCap platform was used. The questionnaire consisted of 22 questions. Ordinal variables were answered using five-point Likert scale (1 = strongly disagree to 5 = strongly agree). The data were analysed using descriptive statistics. Successful implementation was defined as mean overall satisfaction ≥4 and mean understanding of the individual components (adverse reaction category, severity and imputability) in the registration ≥4. RESULTS: In all, 104 staff members (77.9% donation staff) participated. The mean (SD) overall satisfaction among all participants was 3.96 (0.94), highest among medical doctors (4.43 (0.78)) and lowest for administrative or other personnel (2.78 (1.09)). The mean scores for understanding the adverse reaction categories, severity and imputability were 3.92 (0.94), 3.92 (0.94) and 3.88 (1.00), respectively. Experience with a previous donor vigilance system was associated with lower scores. The most successful implementation programme included a medical doctor for introduction and a contact person. CONCLUSION: The goal for successful implementation was not met. However, the overall attitude towards the new registration was positive and indicates that the system is suitable for different staff groups. Our results suggest that implementation could benefit from special attention to administrative staff and those accustomed to another donor vigilance system.

The impact of revised definitions for transfusion-associated circulatory overload and transfusion-related acute lung injury on haemovigilance reporting.

BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI) are serious adverse transfusion reactions. Standardized surveillance definitions are important to ensure consistent reporting of cases. Recently, revised definitions have been developed for TACO and TRALI, the latter of which has not yet been widely implemented. This study aimed to assess the impact of the new TACO and TRALI definitions on haemovigilance reporting. MATERIALS AND METHODS: The Australian Red Cross Lifeblood Adverse Transfusion Reaction database was accessed to identify all cases of suspected or confirmed TACO and TRALI referred from 1 July 2015 to 30 June 2019. Cases were assessed against both the former and new definitions and the results were compared. RESULTS: A total of 73 cases were assessed. There were 48 TACO cases identified. Only 26 of 48 cases strictly met the former 2011 International Society of Blood Transfusion (ISBT) definition of TACO; 6 cases did not meet the definition and 16 cases lacked sufficient clinical details. In comparison, 46 cases met the revised 2018 ISBT definition, with only 2 cases having insufficient details. There were 24 cases of TRALI according to the existing 2004 Canadian Consensus Conference (CCC) definition compared with 25 cases according to the proposed 2019 revised definition. CONCLUSION: The revised TACO definition captured more cases than the former definition. No significant differences were observed in the number of TRALI cases under the proposed new definition. This is the first study to provide validation data for the revised TRALI definition.

A retrospective analysis of haemolytic reactions to intravenous immunoglobulin using data from the Transfusion-Transmitted Injuries Surveillance System (Ontario).

BACKGROUND AND OBJECTIVES: Haemolysis can occur following intravenous immunoglobulin (IVIG) infusion. Haemovigilance data were analysed using a novel approach for including two control groups with no haemolysis to IVIG. Objectives included a summary of all reactions to IVIG, rate estimates and analysis of haemolytic reactions including risk factors. MATERIALS AND METHODS: Canadian haemovigilance data from Ontario (2013-2021), IVIG distribution and transfusion data from the blood supplier, and data from a large local transfusion registry were used. An 'other-reactions' control group included patients with IVIG reactions that were not haemolytic, and registry patients with no-reaction were the 'no-reaction controls'. Descriptive analysis and two logistic regression models for the different control groups were performed. RESULTS: One thousand one hundred and seventy reactions were included. Most common were febrile non haemolytic (26.1%), minor allergic (24.5%) and IVIG headache (15.3%) followed by haemolytic 10.9% (128/1170). Haemolytic reaction rates decreased over time: rates since 2020 estimated between 1.5 and 2.9/1000 kg IVIG used. The regression model for other-reaction controls identified two risk factors for haemolysis: non-O blood group recipients compared with group O recipients (p value = 0.0106) and IVIG dose per 10 g increase (OR 1.359; 95% CI 1.225-1.506). The model using no-reaction controls gave similar results and also showed no pre-medication was associated with a higher risk of haemolysis (OR 29.084; 95% CI 1.989-425.312). CONCLUSION: The frequency of haemolytic reactions has decreased over time. We confirmed non-O blood group recipients and IVIG dose as risk factors for haemolysis and raise the hypothesis that no pre-medication may increase the risk of haemolysis.

First donor haemovigilance system at a national level in China: Establishment and improvement.

BACKGROUND AND OBJECTIVES: No systematic study has measured the incidence of adverse reactions (ARs) to blood donation at the national level in China before 2019. The objective of this study was to establish an effective reporting system to collect information on ARs to blood donation in China. MATERIALS AND METHODS: The status of donor haemovigilance (DHV) in blood collection facilities in China was evaluated, and an online DHV system was established to collect data on ARs to blood donation in July 2019. The definitions of ARs were based on the International Society of Blood Transfusion (ISBT) standards. The prevalence and data quality of ARs from 2019 to 2021 were analysed. RESULTS: A standard online reporting system has been established for ARs to blood donation. In total, 61, 62 and 81 participating sites were included in this pilot study in 2019, 2020 and 2021, respectively. From July 2019 to December 2021, 21,502 cases of whole-blood-related ARs and 1114 cases of apheresis platelet-related ARs were reported, with an incidence of 3.8‰ and 2.2‰, respectively. Data completeness for key reporting elements improved from 41.7% (15/36) in 2019 to 74.4% (29/39) in 2020. Data quality analysis for the year 2021 yielded similar results as for 2020. CONCLUSION: The construction and continuous improvement of the blood donor safety monitoring system prompted the establishment of the DHV system. Improvements have been made to the DHV system in China, with a significant increase in sentinels and higher data quality.

Human immunodeficiency virus, hepatitis C virus and hepatitis B virus incidence in blood donors from 2000 to 2020 in France: Trends and lessons from haemovigilance surveillance.

BACKGROUND AND OBJECTIVES: Data from 21 years (2000-2020) of haemovigilance were used to assess human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) incidence rates in repeat blood donors and the occurrence of transfusion-transmitted (TT) viral infections. MATERIALS AND METHODS: Blood donors who converted for HIV, HCV or HBV markers within serial three-year analysis periods were included. Epidemiological and virological data were retrieved from the national epidemiological donor database and were supplemented with information on blood components and the infection status of recipients of the previous negative donation (D.N-1) of donors who seroconverted. RESULTS: Incidence rates declined from 1.27 to 0.35/100,000 person-years for HIV, from 0.59 to 0.19 for HCV and from 1.66 to 0.18 for HBV. Risk factors and lookback for 232 HIV, 90 HCV and 74 HBV seroconversions were investigated. The main risk factor identified at post-donation interview was having sex with men (47.8% of males) for HIV and a sexual risk for HCV (30.6%) and HBV (37.1%). The viral loads and sequences were retrospectively tested in 191 HIV, 74 HCV and 62 HBV D.N-1 archived samples. Six (five HBV and one HIV-1) were positive all low viral loads. Two recipients were infected by red blood cells from two HBV seroconverting donors before the introduction of HBV-nucleic acid testing. CONCLUSION: HIV, HCV and HBV incidence rates in blood donors declined over the two past decades in France. There is a very small risk of a blood component that tests negative entering the blood supply resulting in TT infections, especially after introduction of molecular assays in donor screening.

Knowledge assessment of a donor adverse reaction severity grading tool by the National Blood Donor Vigilance Programme of India.

BACKGROUND AND OBJECTIVES: The severity grading tool (SGT) was recently designed by the Association for Advancement of Blood and Biotherapies (AABB) to have more objectivity in severity assignment for an adverse donor reaction after blood donation. A study was performed in India to assess the knowledge (post-training) and determine the degree of agreement of the SGT between participating centres and the subject expert group. MATERIALS AND METHODS: This prospective cross-sectional survey-based study was conducted by the National Coordinating Centre (NCC) of the National Blood Donor Vigilance Programme (NBDVP) of India. Thirty-five real-world case scenarios, validated by seven national and two international experts, were sent to the participating centres, and their responses received (diagnosis and severity grade) were compared and analysed. RESULTS: A total of 50 blood centres participated in the study. The overall agreement between the participating centres and the expert group was 66.4%, with a fair Kendall's coefficient of concordance (W) of 0.271 (p-value < 0.05). The degree of agreement was observed to be more than 80% for 12 centres, 60%-80% for 27 centres and <60% for 11 centres. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. CONCLUSION: The SGT will be an efficient mode to have uniform objective reporting of the adverse donor reactions and may be implemented in the NBDVP of India. This study also highlights the need for training of the blood centres on the basic definitions and categorization of the donor's adverse reaction.

Incidence of acute haemolytic transfusion reaction among ABO-incompatible recipients transfused with A3 blood: A case series.

BACKGROUND AND OBJECTIVES: ABO antigens are among the most immunogenic, but the haemolytic risks of ABO incompatibilities involving a donor with a weak ABO phenotype are little documented. MATERIALS AND METHODS: This retrospective case series assessed the incidence of acute haemolytic transfusion reaction (AHTR) among ABO-incompatible recipients of A3 blood in Québec (Canada). Transfusion safety officers reported laboratory AHTR indicators measured ≤24 h pre- and post-transfusion. Because the AHTR case definition of Québec's Hemovigilance System (QHS) leaves significant room for clinical judgement, a two-step approach was used to assess potential cases: Step 1 consisted in a highly sensitive-but unspecific-initial screen that identified all candidate cases per QHS case definition, and Step 2 consisted in a detailed review of candidate cases by two haematologists. RESULTS: Nine donors initially typed as Group B (N = 1) or O (N = 8) were subsequently found to display an A3 B or A3 O phenotype. Eighty-one recipients received ABO-incompatible blood, including 53 (65.4%) with interpretable data. Of these, 29 (54.7%) were classified as candidate cases after Step 1. Following Step 2, no conclusive evidence of AHTR was found: Abnormal pre- versus post-transfusion changes appeared modest, within normal range, insufficient to ascertain AHTR, or were consistent with a pre-existing condition unrelated to AHTR. Two candidate cases had a QHS-reported transfusion reaction; both were unrelated to AHTR. CONCLUSION: In this case series, no conclusive evidence of serious AHTR was found among ABO-incompatible recipients who were inadvertently transfused with A3 blood.

Babesia microti in a Canadian blood donor and lookback in a red blood cell recipient.

BACKGROUND AND OBJECTIVES: We describe the third documented case of autochthonous human babesiosis in Canada and the second in a Canadian blood donor. MATERIALS AND METHODS: Multiple laboratory investigations were carried out on the donor and the immunocompromised recipient of an associated, potentially infectious red blood cell product. RESULTS: The donor had not travelled except for outdoor exposure in south-eastern Manitoba, followed by illness and hospital admission. The donor had a notable parasitaemia, positive for Babesia microti using whole blood nucleic acid testing (NAT). The recipient was negative for B. microti by both serology and NAT. CONCLUSION: There was no evidence of transfusion-transmitted babesiosis.

The new donor vigilance system in Denmark reveals regional differences in adverse reactions supposedly caused by variation in the registration.

BACKGROUND AND OBJECTIVES: In recent years, there has been an increased focus among blood bank professionals on the health and safety of blood donors. In 2019, the Danish Haemovigilance Committee designed a national donor vigilance system to improve the registration of adverse reactions (AR) in blood donors. The new donor vigilance system was implemented on 1 January 2020 and we here present the results from the first year of registration. MATERIALS AND METHODS: AR categories, severity level and imputability score were defined based on the definitions from the International Society of Blood Transfusion, AABB and the European Commission directive 2005/61/EC, respectively. RESULTS: Across all severity levels, AR in Danish blood donors were found to be rare (1498 per 100,000 donations). Only 0.2% of the registered reactions were classified as serious (2.7 per 100,000 donations). Large regional differences were seen in the registration of citrate reactions and haematomas. CONCLUSION: Significant differences across regions in what to categorize as an AR were persistent even when including a severity score in the reporting. The Danish Haemovigilance Committee will commence a national work to align the definitions but suggests that this matter is raised to an international level as part of the current work to agree upon definitions for assessment of donor AR.

Whole blood transfusion and paroxysmal nocturnal haemoglobinuria meet again: Minor incompatibility, major trouble.

BACKGROUND AND OBJECTIVES: The field of transfusion medicine started out with whole blood transfusion to treat severe anaemia and other deficiencies, and then transitioned to component therapy, largely leaving the practice, and experiences, of whole blood transfusions behind. Currently, the field is circling back and whole blood is gaining ground as an alternative to massive transfusion protocols. MATERIALS AND METHODS: Herein we describe a severely anaemic paroxysmal nocturnal haemoglobinuria (PNH) patient initially suspected of suffering from renal haemorrhage, receiving a standard low-titre group O whole blood transfusion during pre-hospital transportation. RESULTS: Following the transfusion, the patient suffered a clinically unmistakable haemolytic transfusion reaction requiring supportive treatment in the intensive care unit. Clinical observations are consistent with an acute haemolytic reaction. The haemolysis was likely due to minor incompatibility between the plasma from the transfused whole blood and the patient's PNH red cells. Recovery was uneventful. CONCLUSION: This revealed an unappreciated contraindication to minor incompatible whole blood transfusion, and prompted a discussion on the distinction between whole blood and erythrocyte concentrates, the different indications for use and the importance of emphasizing these differences. It also calls attention to patient groups where minor incompatibility can be of major importance.

Development of the Chinese Haemovigilance Network and reporting of adverse transfusion reactions from 2018 to 2020.

BACKGROUND AND OBJECTIVES: To advance blood transfusion safety, the Chinese Haemovigilance Network (CHN) was put into operation in 2018. This report describes the development of the CHN and evaluates its role by analysing reported adverse transfusion reactions (ATRs) from 2018 to 2020. MATERIALS AND METHODS: All data in this study were obtained from the CHN online reporting platform. A timeline of CHN development is presented, and the activities of CHN-enrolled facilities are analysed by year. The reported ATRs were analysed in detail for ATR types, blood components involved and adherence to case definition, severity and imputability criteria. Incidence rates were calculated and compared with international examples. RESULTS: During 2018-2020, a total of 3061 ATRs were reported through the CHN online reporting system. The rate of reported ATRs in all facilities and the 10 highest reporting facilities was 0.7‰ and 1.8‰, respectively. When analysed by year, the incidence rate showed an increasing trend from 2018 to 2020. Allergic (68.2%) and febrile non-haemolytic transfusion reaction (27.1%) were the most common. The vast majority of ATRs (92.0%) were not serious, but serious cases of transfusion-associated circulatory overload, transfusion-associated dyspnoea and hypotensive reaction were common. Most (86.0%) of reported cases were definitely or probably associated with transfusion. CONCLUSION: Under-reporting of ATRs occurs in many Chinese hospitals, but the establishment of CHN has increased ATR recognition and management. More effort will be needed in the future to detect transfusion problems and improve transfusion practice in China.

Clinical and in vitro evaluation of red blood cells collected and stored in a non-DEHP plasticized bag system.

BACKGROUND AND OBJECTIVES: Di-ethyl-hexyl-phthalate (DEHP) is currently the main plasticizer used for whole blood collection systems. However, in Europe, after May 2025, DEHP may no longer be used above 0.1% (w/w) in medical devices. DEHP stabilizes red cell membranes, thereby suppressing haemolysis during storage. Here we compared in vitro quality parameters of red cell concentrates (RCCs) collected and stored in DEHP-, DINCH- or DINCH/BTHC-PVC hybrid blood bags with saline-adenine-glucose-mannitol (SAGM) or phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) storage solution. Last, we performed haemovigilance surveillance for RCC collected in DINCH-PVC and stored in PAGGSM/BTHC-PVC. MATERIALS AND METHODS: In vitro quality parameters of RCC were determined during 42 days of storage. Haemovigilance surveillance was conducted to compare the frequency and type of transfusion reaction. RESULTS: Haemolysis levels were increased in SAGM/BTHC-PVC as compared to SAGM/DEHP-PVC (0.66% ± 0.18% vs. 0.36% ± 0.17%). PAGGSM storage solution was able to adequately suppress haemolysis to levels observed during storage in SAGM/DEHP-PVC, both in BTHC-PVC (0.38% ± 0.12%), and to a slightly lesser extent in DINCH-PVC (0.48% ± 0.17%). A total of 1650 PAGGSM/BTHC-PVC and 5662 SAGM/DEHP-PVC RCC were transfused yielding a transfusion reaction frequency of 0.24% (95% CI 0.0000-0.0048) and 0.44% (95% CI 0.0027-0.0061) respectively. CONCLUSION: The in vitro quality of RCC stored in PAGGSM/BTHC-PVC and SAGM/DEHP-PVC is comparable. There is no indication that transfusion of erythrocytes stored in PAGGSM/BTHC-PVC results in increased transfusion reaction frequency. These initial results provide a basis for further clinical evaluation to narrow down the confidence interval of transfusion reaction frequency.

Prevention of hypokalaemia and hypomagnesaemia following peripheral stem cell collection - a prospective cohort study.

BACKGROUND AND OBJECTIVES: Citrate-based anticoagulation reduces plasma potassium and free magnesium in patients undergoing peripheral stem cell collections. Whether the effects may be mitigated by pre-procedure oral electrolyte supplements has not been previously assessed. MATERIALS AND METHODS: Results from a historic cohort (2010-2013) guided a systematic prospective intervention in subjects deemed at risk for clinically meaningful hypokalaemia and hypomagnesaemia. From 2015 to 2019, 136 patients were enrolled in the study. Pre- and post-apheresis electrolyte levels were measured, and oral potassium and magnesium supplements were systematically administered based on the pre- electrolyte levels. RESULTS: We saw a 37% absolute reduction in severe hypokalaemia and 39% absolute reduction in hypomagnesaemia in the prospective intervention cohort when compared to the historic cohort. Multivariate analyses indicated that part of the effect was due to the electrolyte intervention, while part of the effect likely stemmed from other procedure-related changes implemented during the study period. CONCLUSION: Oral potassium and magnesium prophylaxis appear to reduce hypokalaemia and hypomagnesaemia following peripheral stem cell collection. Whether the effect size is sufficient to motivate the intervention warrants further investigation, preferably in a prospective randomized trial setting.