|
|
|
|
Growing US Adoption of Pathogen Reduction – Additional Three Centers Enter into Agreement for Use of INTERCEPT
Community Blood Center of Appleton, Mississippi Valley Regional Blood Center, and Shepeard Community Blood Center have agreed to adopt the INTERCEPT Blood System for Platelets and Plasma, bringing the total number of US centers choosing to adopt pathogen reduction to ten.
“Not only will INTERCEPT processing offer us peace of mind that we are providing blood components of the highest safety standard, it offers Shepeard the opportunity to streamline our supply logistics,” said Kevin Belanger, Shepeard’s President and Chief Executive Officer. “Incorporating INTERCEPT processing into our in-house lab will revolutionize our operations and allow us the potential to release platelet units to our community hospitals with a much quicker turn around. INTERCEPT processing will also eliminate the need for certain time consuming procedures, such as bacterial testing.”
Read the full press releases
|
|
First Patient Enrolled in Cerus’ Phase IV PIPER Study
Smilow Cancer Hospital at Yale-New Haven has enrolled the first patient in the Phase IV INTERCEPT Platelets Entering Routine Use (PIPER) study, a prospective, open-label, non-inferiority, post-marketing surveillance study. “Smilow Cancer Hospital at Yale New-Haven, as a leading U.S. cancer hospital, is dedicated to providing our patients with the best care available,” said Edward Snyder, MD, Professor of Laboratory Medicine and Director of Transfusion/Apheresis/Tissue Implantation Services. “We recognize the risks faced by these immunosuppressed patients and believe that our participation in the PIPER study will allow us to learn more about platelet transfusions and pulmonary events in this seriously ill patient population, as well as to provide the highest level of transfusion safety.”
Yale Cancer Center is one of 45 National Cancer Institute designated comprehensive cancer centers in the U.S., and is Connecticut’s largest cancer care provider, participating in over 150 cancer-focused clinical trials.
The PIPER study will monitor the transfusion of conventional and INTERCEPT-treated platelets in hematology/oncology patients, including those undergoing hematopoietic stem cell transplant, who are expected to require one or more platelet component transfusions. PIPER will evaluate the incidence of severe pulmonary adverse events requiring assisted mechanical ventilation, a clinical concern in transfusion medicine as it relates to repeated platelet transfusions in patient populations at risk for lung injury.
Learn more about the PIPER study
Read the Press Release
|
|
Cerus and Haemonetics Announce Collaboration Agreement for Use of Acrodose Platelet Kits with the INTERCEPT Blood System for Platelets
Under the terms of the five-year agreement, Cerus will have the right to sell Haemonetics’ Acrodose PL and Acrodose PLus systems along with its own INTERCEPT Blood System as a combined product offering. The agreement will commence upon FDA approval for use of the INTERCEPT Blood System for the treatment of pooled platelets derived from whole blood collections, for which Cerus plans to submit an application to the FDA. “Whole blood platelets are a cost-effective production method for some blood centers, potentially made more attractive when combined with INTERCEPT by mitigating hospital concerns regarding the potential increased risk of transfusion-transmitted infections,” said Byron Selman, President of Global Markets for Haemonetics. “We believe that the ability to pair our Acrodose system with pathogen reduction via the INTERCEPT Blood System can provide blood centers with additional options for maintaining availability of platelets for transfusion.”
Read the full press release.
|
|
Science Section: What We're Reading
Pathogen Inactivation: Emerging Indications
Kleinman, S Curr Opin Hematol. November 2015
Read the abstract here (subscription may be required for full access).
Intermittent Bacteremia Detected in an Asymptomatic Apheresis Platelet Donor with Repeat Positive Culture for Escherichia coli: A Case Report
Ramirez-Arcos, S et al. Transfusion. November 2015
Read the abstract here (subscription may be required for full access).
|
|
Calendar of Events
BMT Tandem Meetings | Feb 18-22, 2016 | Honolulu, HI
Additional information
ABC (America's Blood Centers) Annual Meeting | March 12-14, 2016 | Jacksonville, FL
Additional information
CBBS (California Blood Bank Society) Annual Meeting | April 6-9, 2016 | San Diego, CA
Additional Information
ASFA (American Society for Apheresis) Annual Meeting | May 4-7, 2016 | Rancho Mirage, CA
Additional Information
CSTM (Canadian Society of Transfusion Medicine) Annual Meeting | May 11-15, 2016 | Vancouver, BC
Additional Information
|
|
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-00165-06
|
|
|
|
|
|
|
