XXIst Regional Congress of the ISBT
June 18 - 23
7th IABS Symposium on Advances in Transfusion Safety
July 15 - 17
International Symposium on Critical Bleeding (ISCB)
Tuesday June 21, 2011,
12.30 - 14.30 Auditorium I
"Pathogen Inactivation In
Practice : INTERCEPT
Platelets and Plasma for
Support of Routine and
Special Care Patients"
Dr. Matilde Santos, Chair
Dr. Miguel Lozano
( Barcelona, Spain)
Dr. Andreas Buser
Dr. Daniel Kientz
INTERCEPT Activities at ISBT June 18-23rd
ISBT Lisbon will soon be underway. We look forward to welcoming you to our booth in the exhibition hall (#443) and to our lunch symposium on June 21st. In addition, recent INTERCEPT data will be featured during oral and poster presentations.
Symposium : Tuesday June 21, 2011, 12.30 - 14.30 Auditorium I
Posters: The INTERCEPT Blood System for platelets, plasma and red blood cells will be the focus of numerous posters addressing the following concepts:
E.coli Outbreak Puts Spotlight on Blood Availability
In one of the largest outbreaks on record, Germany has been the hardest hit by confirmed cases of hemolytic-uremic syndrome (HUS) as a result of exposure to EHEC, a new strain of E. coli. With dozens of patients in critical care and requiring large volumes of plasma, timely availability of plasma is critical. The widespread use of plasma quarantine in several EU countries including Germany means that newly collected plasma can’t be released for at least 4 months, and as a result, such outbreaks have the potential to strain the blood supply if increased demand levels persist for an extended period of time. In contrast, INTERCEPT plasma can be released immediately after treatment.
INTERCEPT Red Cell Program Progresses Toward Phase 3 Clinical Trial
Safety and viability assessments of INTERCEPT treated RBCs have recently been published in Transfusion (e-pub ahead of print). The safety evaluation, part of the preclinical program for INTERCEPT RBC, concluded that the level of residual S-303 and S-300 in the treated RBC unit is well below that at which no adverse risks were observed. RBC viability was characterized in a phase 1 clinical trial that found INTERCEPT-treated RBCs to be physiologically and metabolically suitable for transfusion after 35 days of storage and met FDA guidance criteria for 24-hour recovery. Based on these results, a phase 3 clinical trial is planned in collaboration with the French national transfusion service and the German Red Cross in Frankfurt.
UK Sees Increase in Imported Cases of Illness From Vector Borne Pathogens
Within the past 2 years, recorded dengue fever infections doubled among UK residents, while both malaria and chikungunya saw an average increase of 30%. Of the confirmed cases of dengue fever, those with recent travel predominately visited destinations in Southeast Asia, the Indian Subcontinent and Thailand. Malaria was frequently connected to residents traveling to West Africa, South Asia or India. Adoption of pathogen inactivation may provide a safe means to relax donor deferrals despite recent travel abroad.
Pathogen Spotlight: Borrelia burgdorferi (Lyme Disease)
Borrelia burgdorferi is a spirochete bacterium that is the causative agent of Lyme borreliosis (Lyme disease), the most prevalent arthropod-transmitted infection in Northern Europe, temperate Asia and North America (Smith R. 2006). Borrelia is transmitted by ticks of the Ixodes genus and reservoir species including birds, several strains of mice, deer, voles and lizards. Lyme borreliosis is a multisystem infection with several stages, including asymptomatic phases, and rather non-specific symptoms that can mimic other infections. While the disease is easily treatable with antibiotics in the early stage, chronic infection is both more difficult to diagnose and more difficult to treat.
Chronic infections that may include long asymptomatic periods make Borrelia a risk for contamination of donated blood and make donor questions unreliable as a screening tool. In addition, several studies have demonstrated the survival of B. burgdorferi for up to 45 days in blood components treated and stored according to modern blood banking practices (Badon 1989, Johnson 1990, Nadelman 1990), confirming it as a potential risk for transfusion transmission. There is no commercially available assay for use in blood screening, but B. burgdorferi is very susceptible to inactivation by the INTERCEPT Blood System; approved claims include inactivation of >6.8 logs in platelets and >10.6 logs in plasma. For a comprehensive review of Lyme borreliosis see Hengge, et al. 2003.
Use of INTERCEPT is contraindicated in patients with a history of allergic response to amotosalen or psoralens.
No pathogen inactivation system has been shown to inactivate all pathogens.
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