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Patient Outcomes and Platelet Utilization in Massively Transfused Patients, Before and After INTERCEPT Implemenation
A retrospective analysis was conducted at a large Austrian medical center to evaluate the efficacy of INTERCEPT Blood System for Platelets during massive transfusion (MT) in general hospitalized patients. In this study, Nussbaumer et al. evaluated component use, in-hospital mortality and length of stay after MT in 306 patients that had undergone cardiac, vascular, trauma or liver transplant surgery. Overall, component use, hospital mortality and median time to discharge in those receiving platelets treated with INTERCEPT was comparable to those that received conventional platelets.1 The researchers concluded that the introduction of INTERCEPT Blood System for Platelets did not adversely affect clinical outcomes in the massively transfused patients in terms of blood product usage, in-hospital mortality and length of stay.
Nussbaumer et al. Vox Sanguinis. 15 February 2017. DOI:10.1111/vox.12489
1 Read the Article Here
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Red Blood Cells Treated with the INTERCEPT Blood System and Stored for 35 Days Retain Post-Transfusion Viability
Red Blood Cells (RBC's) treated with the INTERCEPT Blood System for Red Blood Cells, which is currently in development, uses amustaline (S-303) that forms covalent crosslinks and adducts with nucleic acids to inactivate pathogens. Recently, post transfusion viability of red cells treated with amustaline (S-303) following 35 days of storage was evaluated in a single-blind, randomized, controlled, two-period crossover study. Twenty-six subjects were transfused with an aliquot of radiolabeled RBCs on day 35 to determine 24-h RBC post-transfusion recovery, mean life span, median life span (T50) and life span area under the curve (AUC). Results indicated that RBC’s prepared with amustaline met the FDA criteria for post-transfusion recovery and were metabolically and physiologically acceptable for transfusion following 35 days of storage.1 No serious adverse events were reported in this study.
Cancelas JA et al. Vox Sanguinis. 21 Feb 2017. DOI: 10.1111/vox12500
1 Read the Article Here
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Customer Spotlight: Chris Staub, Chief Operating Officer From the Central California Blood Bank
Q. What were the deciding factors that led Central California Blood Bank to adopt pathogen reduction?
A: I first signed a Cerus agreement in 2015 to produce INTERCEPT Platelets in PAS for Unyts in Buffalo. Now we have implemented INTERCEPT at Central California Blood Center in Fresno. We chose INTERCEPT because we had a desire for safer platelets than conventional, to help our center differentiate itself from others, and to enhance the value of blood. Also, the Zika outbreak and the ever-present risk of future emerging infections and the imminent FDA guidance on bacterial risk in platelets were factors.
Q: You recently wrote an article in Physician’s Edition, a newsletter that reaches health providers in the Community Medical Center Healthcare Network in Central California, informing them about the availability of platelets treated with the INTERCEPT Blood System. What has been the response from readers?
A: The response has been great. “Physician’s Edition” is widely read by all the doctors in our Central Valley, so I was thrilled to have the opportunity to reach that key, broad medical audience. We have been widely congratulated for being the first center in California to adopt the INTERCEPT Blood System to make psoralen treated platelets. Oncologists began asking one of our hospital blood banks for psoralen treated platelets two weeks before we began making them! So the article helped, but what helped even more to bring success on the demand side was our outreach with the Cerus educational team. This outreach really helped educate and establish demand.
Q: If you could share anything with other blood centers regarding the process for adopting the INTERCEPT Blood System, what would it be?
A: Our objective here in Fresno, was to visualize a path to 100% INTERCEPT treated platelets. With the FDA final guidance looming we shall see what happens, but we are confident because we feel we are getting out in front on how our community will best comply when the time comes.
Read the Central California Blood Center - Physician Edition, Newsletter-Jan 2017
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Science Section: What We’re Reading
First Cases of Zika Virus Infected US Blood Donor Outside States with Areas of Active Transmission
Williamson PC et al. Transfusion. 23 February 2017. DOI: 10.1111/trf.14041
Read the Article Here [Full Subscription Required]
Prioritizing of Bacterial Infections Transmitted Through Substances of Human Origin in EU
Domanovic D et al. Transfusion. 24 February 2017. DOI:10.1111/trf.14036
Read the Article Here [Full Subscription Required]
German Travelers Bringing Diverse Dengue Strains
Ellis C. Contagion Live Infectious Diseases Today. 20 February 2017. http://://www.contagionlive.com/news/german-travelers-bringing-diverse-dengue-strains-home
Read the Article Here
Australia’s Mosquito-Borne Ross River Virus Could Become Global Epidemic
Evans J. Abc.net.au. 21 February 2017. http://www.abc.net.au/news/2017-02-22/mosquito-borne-ross-river-virus-could-become-global-epidemic/8294492
Read the Article Here
Yellow Fever – Once Again on the Radar Screen in the Americas
Paules C., Fauci A., NEJM. 8 March 2017. DOI: 10.1056/EJMp1702172
Read the Article Here
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Calendar of Events
CSTM (Canadian Society for Transfusion Medicine)
April 20-23, 2017 | Ottowa, Canada
Additional Information
SCA (Society of Cardiovascular Anesthesiologists)
April 22-26, 2017 | Orlando, FL
Additional Information
ASPHO (The American Society of Pediatric Hematology/Oncology)
April 26-29, 2017 | Montreal, Canada
Additional Information
CBBS
May 3-7, 2017 | Olympic Valley, CA
Additional Information
SCABB
May 25-28, 2017 | Orlando, FL
Additional Information
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Data for pathogen reduction of the ZIKA virus by the INTERCEPT Blood System, pathogen reduction system, have not been submitted for FDA review.
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 00165-21
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