Meta‐analysis of the studies of bleeding complications of platelets pathogen‐reduced with the Intercept system

Vamvakas, Eleftherios C.

doi:10.1111/j.1423-0410.2011.01555.x

Cited by 43 publications

(54 citation statements)

References 55 publications

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“…Results obtained with one method cannot be extrapolated to those obtained by other methods. In the first published meta-analysis that included the HOVON trial, Vamvkas concluded that there was a clinically significant increase in mild and moderate bleeding complications in the arm receiving treated-platelets [85]. However, this meta-analysis contained a serious methodological bias: it combined the results of clinical studies of amotosalem/UVA with the results of a clinical study of riboflavin/broad spectrum UV.…”

Section: Clinical Studiesmentioning

confidence: 95%

The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates

et al. 2014

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Since 1990, several techniques have been developed to photochemically inactivate pathogens in platelet concentrates, potentially leading to safer transfusion therapy. The three most common methods are amotosalen/UVA (INTERCEPT Blood System), riboflavin/UVA-UVB (MIRASOL PRT), and UVC (Theraflex-UV). We review the biology of pathogen inactivation methods, present their efficacy in reducing pathogens, discuss their impact on the functional aspects of treated platelets, and review clinical studies showing the clinical efficiency of the pathogen inactivation methods and their possible toxicity.

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Section: Clinical Studiesmentioning

confidence: 95%

The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates

et al. 2014

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“…The ongoing scientific dispute about the clinical effectiveness of PI-PCs indicated a potentially limited acceptance of the new components by the clinicians. Lower corrected count increments for PI-PCs compared to conventional PCs (cPCs) with unclear clinical significance were reported by meta-analyses [9,10]. Additionally, acute respiratory distress syndrome (ARDS) was described in significantly more patients having received PI-PCs (5/328) than in those transfused with cPCs (0/327 [11].…”

Section: Introductionmentioning

confidence: 99%

Nationwide Implementation of Pathogen Inactivation for All Platelet Concentrates in Switzerland

Jutzi

Taleghani

Rueesch

et al. 2018

Transfus Med Hemother

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Introduction: Bacterial contamination of platelet concentrates (PCs) has been identified as the most prevalent transfusion-associated infectious risk. To prevent PC-related septic transfusion reactions, the Intercept® pathogen inactivation procedure was introduced for all PCs in Switzerland in 2011. Methods: Based on numbers of transfused units and mandatorily reported adverse events with high imputability, we compare the risks associated with transfusion of conventional PCs (cPCs) and pathogen-inactivated PCs (PI-PCs). Results: From 2005 to 2011, a total of 158,502 cPCs have been issued in Switzerland, and 16 transfusion-transmitted bacterial infections (including 3 fatalities) were reported. This corresponds to a morbidity and mortality rate of ca. 1:9,900 and 1:52,800, respectively. From 2011 to 2016, a total of 205,574 PI-PCs have been issued, and no transfusion-transmitted bacterial infection was reported. Despite continuously increasing transfusion reaction rates per 1,000 RBC and plasma issued between 2008 and 2016, we observed reductions of 66% for life-threatening and fatal reactions and of 26% for all high-imputability transfusion reactions related to PI-PCs as compared to cPCs. No increased rates of bleeding or clinical observations of ineffectiveness of PI-PCs have been reported. After implementation of PI-PCs, the annual increase in platelet usage per 1,000 inhabitants decelerated. Discussion: Swiss hemovigilance data confirm a favorable safety profile of the nationwide introduced Intercept pathogen inactivation procedure and its reliable prevention of septic transfusion reactions and fatalities due to bacterially contaminated PCs.

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“…A recent meta‐analysis evaluated the outcome of clinical bleeding across five published randomized controlled trials (RCTs) in INTERCEPT and non‐PI PLT recipients . This meta‐analysis is a revision of a previous meta‐analysis by the same author in the past year, using additional data, including only the INTERCEPT technology and using somewhat different criteria for RCT inclusion and data analysis.…”

Section: Risks Incurred With Implementation Of Intercept Apsmentioning

confidence: 99%

“…The results for clinically significant bleeding (defined as at least Grade 2 bleeding by one of two standardized bleeding measurement scales used in the different studies) varied depending upon which of two US SPRINT trial data sets (per‐protocol bleeding events or bleeding events from AE reporting, which involved a slightly longer observation period) was used. Using per‐protocol data, there was no difference (odds ratio [OR], 1.24; 95% CI, 0.79‐1.93), whereas using AE data, clinically significant bleeding in INTERCEPT recipients was increased by 50% (OR, 1.52; 95% CI, 1.09‐2.12) . As has been pointed out, daily per‐protocol bleeding assessment using WHO criteria is a more objective and accurate tool than is spontaneous hemorrhagic AE data obtained by untrained personnel as part of global adverse event (AE) monitoring.…”

Section: Risks Incurred With Implementation Of Intercept Apsmentioning

confidence: 99%

A patient‐oriented risk–benefit analysis of pathogen‐inactivated blood components: application to apheresis platelets in the United States

2012

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We performed a risk-benefit analysis for implementation of pathogen-inactivated (PI) apheresis platelets (APs) in the United States, focusing on the amotosalen/ultraviolet-A system. Risks and benefits were quantified per patient assuming a mean of 6 AP units per treatment cycle and using available clinical data, mathematical modeling, and observational studies. Current risks associated with AP transfusion can be divided into known partially addressed risks, known well-addressed risks, and unknown risks associated with acute or chronic emerging infectious agents (EIAs). Bacterial contamination dominates the first category, at a per-patient rate of 1:250, which correlates with an estimated septic transfusion reaction rate of 1:1000. Quantitation of per-patient EIA risk was modeled to be between 1:370 (acute) and 1:667 (chronic). Due to its broad range of action PI is expected to reduce or eliminate these infectious risks and also to reduce the rate of febrile transfusion reactions and possibly alloimmunization. These benefits are weighed against 1) concerns for excess bleeding, 2) an apparent increase in acute respiratory distress syndrome in the initial report of the SPRINT clinical trial, and 3) the possible toxicity associated with the introduction of a new chemical into platelet (PLT) units. However, transfusion of an estimated 100,000 patients with PI PLTs worldwide has occurred without reported serious adverse effects. We conclude that evidence indicates a favorable risk-benefit profile for the implementation of PLT PI and argues for a path forward toward US regulatory approval.

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Meta‐analysis of the studies of bleeding complications of platelets pathogen‐reduced with the Intercept system

Abstract: Treatment with Intercept may increase the risk of all and clinically significant (albeit not severe) bleeding complications in RCTs maintaining a platelet count of ≥10×10(9) or ≥20×10(9)/l through increased platelet transfusions.

Cited by 43 publications

References 55 publications

The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates

The clinical and biological impact of new pathogen inactivation technologies on platelet concentrates

Nationwide Implementation of Pathogen Inactivation for All Platelet Concentrates in Switzerland

A patient‐oriented risk–benefit analysis of pathogen‐inactivated blood components: application to apheresis platelets in the United States

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