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In this Issue
WSJ Article Highlights Pathogen Reduction | Pathogen Reduction Added to AABB COI | AABB Abstracts Published in Transfusion | TRUE Study Progress AABB Pathogen Reduction Corporate Symposium Creative Cryo AABB In-Booth Presentation | Science Section: What We're Reading | Calendar of Events
Wall Street Journal Article Highlights Pathogen Reduction as a Means to Protect the Blood Supply
Though testing efforts have significantly reduced the risk for established transfusion-transmitted infections, residual risks to our blood supply remain.  Cases of new and emerging pathogens, such as chickungunya and dengue in the Caribbean, and Babesiosis in the United States, are on the rise and add to the list of transfusion-transmission risks. With no commercially approved tests for these and other emerging pathogens, blood centers and hospitals alike remain concerned about the rising risk of contamination in our blood supply.

The INTERCEPT Blood System offers a proactive approach to blood safety. Dr Edward Snyder, professor of laboratory medicine at Yale School of Medicine and director of transfusion services at Yale-New Haven said “even with its limitations, pathogen reduction allows blood centers to be more proactive about disease threats, and could reduce costs by eliminating the need for some testing”.
 

Click here to read the full article.
 
Pathogen Reduced Components added to AABB COI
AABB has recently approved interim language to address pathogen reduced plasma and platelet components for use with the current (November 2013) Circular of Information (COI). Recommendations were prepared by a task force comprised of representatives from AABB, the American Red Cross, America's Blood Centers, the Armed Services Blood Program, and the FDA. The COI, which is recognized by the FDA as an extension to the blood component label, is an essential reference document for Healthcare Providers involved in transfusion medicine.  The interim language, will be incorporated at a later date into the Further Processing section of the Circular. In the meantime, suggested methods for inserting language into the Circular include use of an adhesive label or an ink stamp.

For more information, please click here to visit the AABB website.
 
AABB 2015 Abstracts Published in Transfusion
Abstracts from the AABB Annual Meeting taking place in Anaheim, CA October 24-27, 2015 have been published in a special issue supplement to Transfusion. A number of pathogen reduction focused abstracts have been accepted for oral and poster presentations including:

Oral Presentation A18-030H | Monday, October 26, 2015 | 4:30-4:45 PM
Implementation and Optimization of the INTERCEPT Blood System for Platelets and Plasma in a US Blood Center (Nare, C et al.)

Oral Presentation S82-040C | Tuesday, October 27, 2015 | 2:00-2:15 PM
Investigation of Bacterial Inactivation as a Function of Time Between Collection and Treatment (Wagner, SJ et al.)

Poster Presentations | Saturday, October 24, 2015 | 12:00-2:00 PM (Meet the Author lunch)
SP-39 In Vitro Evaluation of Platelets in PAS-3 Prepared with the INTERCEPT Blood System (Shaz, BH et al.)
SP-55 Frozen Stability of INTERCEPT FFP and PF24 (Waldhaus, K et al.)

Over 100 Platelet Components Transfused in TRUE Study

Cerus’ TReatment UsE (TRUE) study, being conducted with the American Red Cross in Puerto Rico, now has seven sites recruiting patients, including the Veterans Association hospital, and has produced over 100 platelet components for transfusion.  The TRUE study was initiated under an expanded access Investigational Device Exemption (IDE) in 2014 in response to outbreaks of chikungunya and dengue virus in the region. Following the IDE approval, the Puerto Rico Department of Health revised its administrative order to  recognize the role of pathogen reduction in reducing the risk of transfusion transmitted pathogens. With this revision, Blood centers are permitted to provide pathogen reduced blood components as an alternate to the 72-hour quarantine of donated blood.  The FDA approved INTERCEPT Blood System for Platelets pathogen reduction system has demonstrated high inactivation of chikungunya (≥5.7 logs) and dengue virus ( ≥4.3 logs) and is gaining adoption momentum throughout the United States.
Speakers: Richard J. Benjamin, MD, PhD, FRCPath (Chairman), James P. AuBuchon, MD, and Joanne Becker, MD. The 2014 FDA approval of the INTERCEPT Blood System for Platelets and Plasma, coupled with the expressed need for the mitigation of transfusion-transmitted infections is shifting the landscape of blood safety and transfusion medicine. This symposium will examine the role pathogen reduction can play in meeting the needs of blood centers and hospitals who strive to deliver timely, safe, and efficacious products to meet patient needs. During this interactive program speakers and panelists will discuss the INTERCEPT Blood System, including potential operational efficiencies gained, and the value that INTERCEPT-treated components may provide to patients. The symposium will be followed by a networking reception.
 
To learn more about this program, and to pre-register today, please visit www.intercept-usa.com/aabb15
 
Creative Cryo: Exploring fibrinogen replacement therapies, advantages and disadvantages
Fibrinogen replacement therapy is typically indicated for the prophylaxis and treatment of hemorrhage such as in liver failure, cardiac surgery, and massive transfusion in trauma. Main sources of fibrinogen are fresh frozen plasma, cryoprecipitate and fibrinogen concentrate. In this booth talk, Dr. Nascimento, will present an overview of the use of such therapies, as well as their advantages and disadvantages. The potential role of pathogen reduction in producing plasma-derived products will also be discussed.  Raffle: Attend this presentation and you will be entered into a raffle to receive a gift certificate for the AABB Marketplace. Drawing to be held following conclusion of talk. Must be present to win.

To learn more and to pre-register for this event, please click here.
Science Section: What We're Reading

Bacterial Pathogen Reduction Requires Validation Under Conditions of Intended Use
Benjamin, RJ, Wagner, SJ 2015 Sep;55(9):2060-3. doi: 10.1111/trf.13232.
Read the full article here (subscription required for full access).


The Response to Ebola - Looking Back and Looking Ahead
Marchbein, D JAMA. 2015;314(11):1115-1116. doi:10.1001/jama.2015.11645.
Read the full article here (open access).


The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource Constrained Settings: A Perspective from the Field
van Griensven, J et al. 2015 Aug 10. pii: civ680. [Epub ahead of print]
Read the full article here (open access).


Risks Associated with Red Blood Cell Transfusions: Potential Benefits from Application of Pathogen Inactivation
Kleinman, S, Stassinopoulos, A Transfusion. 2015 Aug 25. doi: 10.1111/trf.13259. [Epub ahead of print]
Read the full article here (open access).
 
Calendar of Events
AABB Annual Meeting | October 23-27, 2015 | Anaheim, CA ISBT Regional Conference | November 14-16, 2015 | Bali, Indonesia
There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS and PRECAUTIONS: Only INTERCEPT Processing Sets for platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System contain polyvinyl chloride (PVC). Di(2-ethylhexyl) phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.


PLASMA: Amotosalen-treated plasma may cause the following adverse reaction Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

Rx only. For full prescribing information, please see package insert.
MAN-EN-00165-04
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