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SPECIAL EDITION : AABB 2017 ANNUAL MEETING
Cerus Industry Workshop at AABB 2017Oral and Posters Presentations featuring Pathogen Reduction Cerus Booth at the Exhibit Hall |   Calendar of Events
Cerus Industry Workshop at AABB 2017 Annual Meeting San Diego, CA  :

EXPERIENCES IN IMPLEMENTING PATHOGEN REDUCTION – From Maintaining Split Rates at the Blood Center to Treating Patients at the Hospital

Tues Oct 10 | 7:00 - 8:15AM | Room A/B at SC Convention Center


Pathogen reduction is being implemented to mitigate transfusion transmitted infectious risks and potentially TA-GVHD risk, in light of high-risk patient populations, anticipated FDA guidance for bacterial contamination and Zika1 virus requirements. To-date, over 40 US centers are either already distributing or are preparing to distribute pathogen reduced platelets to hospitals. This session will highlight experiences after implementing pathogen reduction at both the blood center and hospital. Blood center considerations to be discussed include methods used to optimize the availability of pathogen reduced products, such as the adjusting or “splitting”2 of larger collections to meet INTERCEPT Blood System specifications, and the optimization of collection platform settings. Patient benefits in receiving transfusion-ready pathogen reduced platelet products will also be discussed from a hospital’s perspective.
 
Our program will include the following presentations:
  • Introduction: Integration of Pathogen Reduced Platelets into the Yale Blood Supply
    Dr. Ed Snyder, Director, Transfusion/Apheresis/Tissue Implantation Services at Yale-New Haven Hospital

     
  • Optimizing Platelet Production to Maximize INTERCEPT Compatibility
    Elan Weiner, Director of Deployment and Blood Center Services at Cerus

     
  • Hospital Adoption of Transfusion-Ready Pathogen Reduced Blood Products
    Dr. Dawn Ward, Associate Medical Director at UCLA Health System
We hope to see you at the Cerus Workshop!

Download the invitation (Pdf - 335kb)
Pathogen Reduction Orals and Posters at AABB 2017 Annual Meeting
Sixteen posters and 3 orals describing experiences with the INTERCEPT Blood System will be presented at AABB. Key presentations of interest include the following. For a full list of abstracts, including those below, please visit the listing here.

Oral Presentations:
  • Monday, October 9, 2017 | San Diego Convention Center, Room 29A | Clinical Session: Components - Novel Platelet Product Characterization and Testing:
    Compatibility of Apheresis Platelet Collections with Pathogen Reduction While Maintaining Current Split Rates (E Weiner, V Chrebtow)
  • Monday, October 9, 2017 | San Diego Convention Center, Room 25AB | Clinical Oral Abstract Session: Transfusion Transmitted Diseases - Classic Viruses:
    Robust Inactivation of Mayaro Virus in Platelet Concentrates and Red Blood Cells using nucleic acid targeting pathogen reduction technologies (PRT) (F Santa Maria, A Laughhunn, Y Girard, et al.)
  • Tuesday, October 10, 2017 | San Diego Convention Center, Room 30ABC | Clinical Session: Transfusion Transmitted Diseases - Bacteria and Parasites:
    Hemovigilance Monitoring of Platelet Septic Transfusion Reactions (STR) after Treatment with INTERCEPTTM Pathogen Reduction or Large Volume, Delayed BacT/ALERTTM Bacterial Culture Screening. (R Benjamin, M Lanteri, L Corash)
Posters:
On Display During Exhibition Hours: San Diego Convention Center, Poster Hall E
Poster Session: Saturday, October 7th | 12 noon - 2:00pm


Platelets:
  • Poster AP49: Cost and Shelf Life Implications of Pathogen Reduced Platelets: A Hospital Budget Impact Model (KM Prioli,  NM Lyons, JK Karp, et al.)
  • Poster AP64: Logistical Management of the Incorporation of Pathogen Reduced Single Donor Platelets (PR-SDP) into Inventory at a U.S. Tertiary Care Medical Center (E Gehrie, R Ross, D Mraz, et al.)
  • Poster CP40: Compatibility of Platelet Collections for Treatment with the Intercept Blood System for Platelets (M Lummer, C Todd)
  • Poster CP155: Phased Integration of Pathogen Reduced Platelets (PR-PLTS) into Inventory at an Academic Medical Center and Preliminary Assessment of Impact on Pediatric Patient Care (E Gehrie, B Spencer, S Merenda, et al.)
  • Poster CP274: Comparison Of Clinical Efficacy And Safety Of The Pathogen Reduced And γ –Irradiated Platelet Concentrates (Azimova M.H., Galstyan G.M., Gaponova T.V., et al.)
  • Poster 358: Robust Inactivation of the Yellow Fever Virus 17D Strain Can Be Achieved Using Amotosalen and UVA Light for Pathogen Reduction Treatment (PRT) Of Platelet Components (A Laughhunn, F Santa Maria, Y Girard, et al.)3

Plasma:

  • Poster CP327: Efficient Inactivation of MERS Coronavirus In Human Plasma with Amotosalen and UVA Light (SI Hindawi, AM Hashem, GA Damanhouri, et al.)
  • Poster CP343: Pathogen Reduced FFP and PF24 Cryoprecipitate Retain In Vitro Hemostatic Capacity 5 Days Post Thaw (T Berry, P Schmidt, N Lakshman, et al.)4

Red Blood Cells:5

  • Poster BP7: Compatibility of the INTERCEPT® Blood System for Red Blood Cells (RBC) with Leukocyte Reduced (LR) AS-1, AS-3 and AS-5 RBCs (MA Schott, B Warbington, G Villegas, et al.)
  • Poster CP355: Qualification Of The Intercept Blood System For Red Blood Cells At Banco De Sangre De Servicios Mutuos (J Rodriguez, JO Alsina, A Raffucci Pino, et al.)
Cerus Exhibit booth at the AABB 2017 Annual Meeting
The Cerus /INTERCEPT Booth #1910 will be located in the main AABB Exhibition hall.
 
2017 Calendar of Events

AABB
October 7-10, 2017 | San Diego, CA  
Additional Information

ASA (American Society of Anesthesiologists)
October 21-25, 2017 | Boston, MA  
Additional Information
1) Data for pathogen reduction of the Zika virus by the INTERCEPT Blood System have not been submitted for FDA review. 2) Blood centers should follow local and state regulations when implementing "adjusting" or "splitting" practices and consult the FDA if they intend to establish a pathway for product licensure. 3) Data for pathogen reduction of Yellow Fever Virus by the INTERCEPT Blood System, pathogen reduction system, has not been submitted for FDA review. 4) Data for pathogen reduction of cryoprecipitate by the INTERCEPT Blood System, pathogen reduction system, has not been submitted for FDA review. 5) The INTERCEPT Blood System for Red Blood Cells is in development and is not approved for sale. 

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.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.


Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-26
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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