Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs
Pathogens (Basel, Switzerland). 2022;11(6)
In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel-Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.
Pathogen Reduction Technologies and Their Impact on Metabolic and Functional Properties of Treated Platelet Concentrates: A Systematic Review
Seminars in thrombosis and hemostasis. 2022
Pathogen reduction technologies (PRTs) such as Mirasol and Intercept were developed to eliminate transfusion-transmitted infections. The impact of PRTs on platelet function during the storage period, their effect on platelet storage lesions, and the optimal storage duration following PRTs have not been clearly defined. The aim of this study was to systematically review the existing literature and investigate the impact of PRTs on functional alterations of PRT-treated platelets during the storage period. The authors identified 68 studies suitable to be included in this review. Despite the high heterogeneity in the literature, the results of the published studies indicate that PRTs may increase platelet metabolic activity, accelerate cell apoptosis, and enhance platelet activation, which can subsequently lead to a late exhaustion of activation potential and reduced aggregation response. However, these effects have a minor impact on platelet function during the early storage period and become more prominent beyond the fifth day of the storage period. Large in vivo trials are required to evaluate the effectiveness of PRT-treated platelets during the storage period and investigate whether their storage can be safely extended to more than 5 days, and up to the traditional 7-day storage period.
Molecular and serological markers of human parvovirus B19 infection in blood donors: A systematic review and meta-analysis
Asian journal of transfusion science. 2021;15(2):212-222
BACKGROUND Human parvovirus B19 (B19V) is one of the blood-borne viruses. The virus can be transmitted to susceptible individuals by blood or blood products. The virus is not associated with significant disease in general population, while people with underlying problems such as immunodeficiency can cause anemia and arthritis. The current systematic review and meta-analysis aimed to estimate the overall prevalence of B19V DNA, anti-B19V IgG, and anti-B19V IgM antibodies in blood donors worldwide. METHODS A systematic search was carried out in online databases for relevant studies from inception until March 30, 2019. Study selection was performed based on predesigned eligibility criteria. The proportion of B19V DNA, anti-B19V IgG, and anti-B19V IgM antibodies were pooled using the inverse variance method. All statistical analyses were performed using the R version 3.5.3, package "meta." RESULTS According to the random-effects model, the pool prevalence of B19V DNA, anti-B19V IgM, and anti-B19V IgG among blood donors was calculated to be 0.4% (95% confidence interval [CI] =0.3%-0.6%), 2.2% (95% CI = 1.3%-3.7%), and 50.1% (95% CI = 43.1%-57.1%), respectively. CONCLUSION For the transmission of B19V through blood, the presence of the virus genome is required, and the present study showed that the prevalence of the virus genome in blood donors is <1%. Therefore, there is no need to screen donated blood for B19V infection.
Filariasis and transfusion-associated risk: a literature review
Vox sanguinis. 2021
BACKGROUND AND OBJECTIVES Filariae are parasitic worms that include the pathogens Loa loa, Onchocerca volvulus, Wuchereria bancrofti, Brugia spp. and Mansonella spp. which are endemic in parts of Africa, Asia, Asia-Pacific, South and Central America. Filariae have a wide clinical spectrum spanning asymptomatic infection to chronic debilitating disease including blindness and lymphedema. Despite successful eradication programmes, filarial infections remain an important -albeit neglected - source of morbidity. We sought to characterize the risk of transfusion transmission of microfilaria with a view to guide mitigation practices in both endemic and non-endemic countries. MATERIALS AND METHODS A scoping review of scientific publications as well as grey literature was carried out by a group of domain experts in microbiology, transfusion medicine and infectious diseases, representing the parasite subgroup of the International Society of Blood Transfusion. RESULTS Cases of transfusion-transmitted filariasis are rare and confined to case reports of variable quality. Transfusion-associated adverse events related to microfilariae are confined to isolated reports of transfusion reactions. Serious outcomes have not been reported. No known strategies have been implemented, specifically, to mitigate transfusion-transmitted filariasis yet routine blood donor screening for other transfusion-transmissible infections (e.g. hepatitis B, malaria) may indirectly defer donors with microfilaremia in endemic areas. CONCLUSION Rare examples of transfusion-transmitted filariasis, without serious clinical effect, suggest that filariasis poses low transfusion risk. Dedicated mitigation strategies against filarial transfusion transmission are not recommended. Given endemicity in low-resource regions, priority should be on the control of filariasis with public health measures.
Residual bacterial detection rates after primary culture as determined by secondary culture and rapid testing in platelet components: A systematic review and meta-analysis
BACKGROUND Primary culture alone was a bacterial risk control strategy intended to facilitate interdiction of contaminated platelets (PLTs). A September 2019 FDA guidance includes secondary testing options to enhance safety. Our objective was to use meta-analysis to determine residual contamination risk after primary culture using secondary culture and rapid testing. STUDY DESIGN AND METHODS A December 2019 literature search identified articles on PLT bacterial detection rates using primary culture and a secondary testing method. We used meta-analysis to estimate secondary testing detection rates after a negative primary culture. We evaluated collection method, sample volume, sample time, and study date as potential sources of heterogeneity. RESULTS The search identified 6102 articles; 16 were included for meta-analysis. Of these, 12 used culture and five used rapid testing as a secondary testing method. Meta-analysis was based on a total of 103 968 components tested by secondary culture and 114 697 by rapid testing. The residual detection rate using secondary culture (DR(SC) ) was 0.93 (95% CI, 0.24-0.6) per 1000 components, while residual detection rate using rapid testing (DR(RT) ) was 0.09 (95% CI, 0.01-0.25) per 1000 components. Primary culture detection rate was the only statistically significant source of heterogeneity. CONCLUSION We evaluated bacterial detection rates after primary culture using rapid testing and secondary culture. These results provide a lower and upper bound on real-world residual clinical risk because these methods are designed to detect high-level exposures or any level of exposure, respectively. Rapid testing may miss some harmful exposures and secondary culture may identify some clinically insignificant exposures.
The incremental benefit of anaerobic culture for controlling bacterial risk in platelets: a systematic review and meta-analysis
Vox sanguinis. 2020
BACKGROUND AND OBJECTIVES Septic transfusion reactions are a principal cause of transfusion-related mortality. The frequency of detectable bacterial contamination is greater in platelets compared to other blood components because platelets are stored at room temperature. Most strategies outlined in the September 2019 FDA guidance require both aerobic culture (AC) and anaerobic culture (AnC) testing. We performed a systematic review and meta-analysis in an effort to provide the best available estimate of the effectiveness of AnC. MATERIALS AND METHODS Our analysis was performed according to published guidelines. Broad and context-specific meta-analyses of bacterial detection rates in platelets by AnC were performed to assess the practical effectiveness of AnC as a risk control measure. RESULTS Seven studies with a total of 1 767 014 tested platelet components were included for analysis. With exclusion of positives due to Cutibacterium/Propionibacterium species and redundancy due to AC results, AnC detected 0·06 contamination events per thousand (EPT) components tested, twofold lower than the AC (0·12 EPT). CONCLUSION Excluding Cutibacterium/Propionibacterium species, AnC detects occasional bacterial contamination events that are not detected by AC (~1 in 17 000 platelet components).
Pathogen Reduction Technology: A Novel Possibility for Inactivation of Blood Products Used in Oral and Periodontal Surgeries
Journal of International Society of Preventive & Community Dentistry. 2020;10(6):713-718
Emergency surgical treatment has been challenging and the risk of blood contamination has been high, which is a concern among the medical and dental fraternity. The risk outweighs the benefits in these unprecedented times if proper screening and inactivation of blood products are not performed. Pathogen reduction technologies incorporate various modalities for the inactivation of blood products mainly related to blood transfusion. Oral surgical procedures and periodontal surgeries use platelet-rich fibrin for various regenerative procedures that amplify the prognosis positively. The use of blood products for various treatments could result in contamination, a factor which should be significant attention. The objective of this study was to review the role of pathogen reduction technology in inactivating pathogens in blood products and its use in oral and periodontal surgical procedures. The literature presented in the study is from original studies from a period of 2000 to 2020 which was sourced from Medline, PubMed, and Cochrane central databases. Relevant published papers and in-press papers that provided information were identified and selected. The studies presented have shown data related to implementation of pathogen reduction technologies in relation to the severe acute respiratory syndrome, Middle East respiratory syndrome, and its possible implementation in coronavirus disease-2019 (COVID-19). The paper reviews the various technologies offered and the possibility to eradicate pathogens found in routine blood products, used in oral and periodontal surgical procedures. In all probability, the use of pathogen reduction technology might offer a ray of light to contain the spread among dental treatment procedures.
Technical Procedures for Preparation and Administration of Platelet-Rich Plasma and Related Products: A Scoping Review
Frontiers in cell and developmental biology. 2020;8:598816
INTRODUCTION Platelet-rich plasma is widely used for different types of clinical situations, but universal standardization of procedures for its preparation is still lacking. METHODS Scoping review of comparative studies that have assessed at least two alternatives in one or more stages of preparation, storage and/or administration of PRP or its related products. A systematic search was conducted in MEDLINE, Embase, and LILACS. Two authors screened references independently. Data extraction was performed iteratively, and results were presented for each included comparison. RESULTS Thirty-nine studies were included after assessing full texts, focusing on the comparison of PRP to a related product, types of anticoagulants, centrifugation protocols, commercial kits, processing time, methods for activation, and application concomitantly to other substances. Only laboratory outcomes were assessed, as platelet, leukocyte and growth factor concentrations. CONCLUSION Results showed great variability related to methods employed in different stages of PRP processing, which may explain the variability observed in clinical trials assessing the efficacy of PRP for different clinical situations.
[Effect of plateletpheresis on the white blood cell count: meta-analysis 1980-2018]
Revista espanola de salud publica. 2019;93
BACKGROUND In the scientific literature, the impacts of plateletpheresis on leukogram parameters are not clear, with a high divergence in the studies that have evaluated changes in leukocytes. The objective of this paper was to meta-analyze the effect of plateletpheresis on the leukocyte count, based on studies published between 1980-2018. METHODS Systematic review with meta-analysis of random effects for the difference of means. The phases of the PRISMA guide were applied with 132 search strategies in Pubmed, Scielo, Science direct and Scopus. Reproducibility and evaluation of methodological quality were guaranteed. Heterogeneity was evaluated with Galbraith and Dersimonian and Laird's, publication bias with Funnel Plot and Begg; sensitivity analysis, accumulated meta-analysis and Forest Plot were carried out. RESULTS Nineteen studies were included with 2,358 donors, mostly from India, United States, Turkey, Germany and Austria. A mean difference of -0,80 x109L (IC95%= -1,96; 0,36x109L) between the predonation value and the value immediately after donation was founded; no publication bias was found and the conclusion presented good sensitivity since it does not vary with the elimination of studies in successive phases. CONCLUSIONS The donation of platelets by apheresis does not affect the leukocyte count in the donors, in the last century there were reports of reductions in this parameter, explained by the blood loss in the cases used for the procedure and by effects produced in the blood cells by the biomaterials; however, at present the high safety of plateletpheresis for the white blood cell count is evidenced.
Prevalence of Zika virus in blood donations: a systematic review and meta-analysis
BMC infectious diseases. 2019;19(1):590
BACKGROUND Transfusion-Transmitted Zika virus (TT-ZIKV) has become an emerging threat to world blood banks due to the fast spread of ZIKV epidemics and high rate of asymptomatic infections. For the risk assessment of ZIKV infection in blood products, relevant studies in blood donations or blood donors tested for ZIKV were collected and analyzed systematically. The overall prevalence of ZIKV infection were estimated through meta-analysis and potential risk factors were detected. The results will provide important clues for the protocol design of blood screening tests. METHODS Relevant articles about the rate of ZIKV detected in blood samples were identified from PubMed, Scopus and Web Of Science using key terms search strategy until October 7, 2017. Eligible articles were screened following inclusion and exclusion criteria. Meta-analysis and subgroup analyses were performed by software R3.4.1. Overall postdonation and posttransfusion follow-ups were analyzed. RESULTS Ten literatures (528,947 blood samples) were included for meta-analysis. The overall pooled prevalence of ZIKV (RNA and antibody) in blood donations was 1.02% (95%CI 0.36-1.99). The pooled prevalence of ZIKV RNA in blood donations was 0.85% (95%CI 0.21-1.88) less than the pooled prevalence of anti-ZIKV antibodies 1.61% (95%CI 0.03-5.21), however the difference was not statistically significant (p = 0.52). The prevalence varied significantly in different geographical regions (p < 0.001). Blood donations were more than two times likely to be infected by ZIKV in Zika epidemic period (1.37, 95%CI 0.91-1.91) than in non-epidemic period (0.61, 95%CI 0-2.55). The prevalence of anti-ZIKV antibodies (1.61, 95%CI 0.03-5.21) was almost twice as much as ZIKV nucleic acid detected in blood donations (0.85, 95%CI 0.21-1.88). However, statistically significant differences were not observed. A total of 122 ZIKV positive blood donors were followed, of which 48 (39%) reported symptoms postdonation, but none of the 13 followed recipients reported any clinical symptoms related to Zika infection posttransfusion. CONCLUSION The pooled prevalence of Zika infection in blood donations was 1.02%. The prevalence varied greatly and reached to high-risk level in most of the situations. The results suggest that nucleic acid tests (NAT) for blood screening and pathogen reduction/inactivation technology (PRT) should be implemented in Zika-endemic areas and appropriate strategies should be designed according to different conditions. More studies are needed in the future to provide more evidence.