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Production Profile
An early adopter of the INTERCEPT Blood System™, the Blood Transfusion Center UCL Mont-Godinne, Etablissement de Transfusion Sanguine, supplies all of the blood components required by the 400-bed teaching hospital of the Université Catholique de Louvain (UCL) in Belgium. After 5 years of routine use, INTERCEPT treated platelets have demonstrated an excellent safety and efficacy profile. "Adverse patient reactions to transfusions have even decreased thanks to the use of INTERCEPT, with lower patient care costs as a result," explains Dr. Jean-Claude Osselaer, Founder and Medical Director.
On an annual basis, the Blood Transfusion Center (BTC) collects approximately 7,000 whole blood donations and performs over 2,000 apheresis procedures to support a diverse patient population, with major sub-populations cared for by hematology-oncology and cardio-vascular surgery specialists.
Dr. Osselaer initiated universal routine use of platelet components prepared with the INTERCEPT Blood System in 2003. “Early on, I was convinced of the intrinsic value of a pathogen inactivation approach to ensure blood safety. Bacterial detection and testing methods have too much variability and too little sensitivity, which could lead to both medical and legal issues. Medically, using bacterial detection, no transfusion center can guarantee a fully closed loop of control in the supply chain, leaving a window period for bacterial contamination to evolve freely. Legally, it is hard to explain why one would produce components that have only been tested versus pathogen inactivated. This has clearly been demonstrated over the last 20 years for plasma fractions, for which pathogen inactivation is mandated.”
Production Lab
INTERCEPT processing at BTC Mont-Godinne is adjacent to the platelet preparation facility for production efficiency. The process space allocated to INTERCEPT is less than 20m2. The blood center takes advantage of the stackable design of the INTERCEPT illuminator to minimize the space required for treatment. The illuminators include a tray-tilt feature which facilitates loading and unloading of products in the upper illuminator, as well as routine cleaning.
A Streamlined Workflow
"There is no blood safety technology easier to implement than INTERCEPT," claims Dr. Osselaer. “When we adopted pathogen inactivation, it did not require additional personnel to the center, nor did it cause any delays in platelet production. Also, it did not affect the number of platelet donors required to support the patient population of the hospital. The implementation of INTERCEPT actually contributed to overall efficiency of the center by streamlining production and logistics of platelet supply. Supply of platelet components over weekends and holidays is no longer a problem with the 7-day shelf life claim for INTERCEPT.”
Proven Product Quality and Safety
During the 3-year period of INTERCEPT use, all platelet components were collected on the Amicus Cell Separator with integral platelet additive solution addition. More than nine thousand collections were performed with a mean yield of nearly 7 x 1011 platelets.
“In routine use at our hospital, the adoption of pathogen inactivation for platelet components had no significant negative impact on utilization. The results were measured by multiple indices including: mean number of transfusions per patient, mean total dose of platelets per patient, and mean platelet dose per day of support. For all patients supported with platelet components during the two periods, the red cell transfusion requirements per patient were not different before and after introduction of pathogen inactivation."
Dr. Osselaer states, “Our experience demonstrates that INTERCEPT can be implemented into routine practice without impacting platelet or red cell component utilization. Moreover, the use of PI resulted in a trend of decreased acute transfusion reactions on a per transfusion and per patient basis.”
Table 1: ULC Mont-Godinne QC Results for INTERCEPT Platelets - Apheresis
|
Parameter |
INTERCEPT Platelets
(Average ± SD)
|
N
|
|
Volume (mL) |
317 ± 9.4
|
3,000
|
|
Platelet count (x1011 plt/unit) |
3.9 ± 0.9
|
3,000
|
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Table 2: ULC Mont-Godinne QC Results for INTERCEPT Platelets - Buffy Coat
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Parameter |
INTERCEPT Platelets
(Average ± SD)
|
N
|
|
Volume (mL) |
327 ± 4
|
150
|
|
Platelet count (x1011 plt/unit) |
3.8 ± 0.5
|
150
|
|
a. Nominal treatment concentration prior to illumination is 150 μM. |
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Table 3: UCL Mont-Goddine Results for INTERCEPT Plasma
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Parameter |
INTERCEPT Platelets
(Average ± SD)
|
N
|
|
Volume (mL)a |
210 ± 5.9
|
1,500
|
|
Factor VIII (IU /mL)b |
1.1 ± 0.4
|
102
|
a. QC results.
b. Validation results. |
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Economic Advantages of Pathogen Inactivation
While it was important to demonstrate the safety and efficacy of INTERCEPT platelets in routine use, it was also necessary to document the economic impact on blood center operations. The adoption of INTERCEPT did not adversely impact the cost of donor recruitment or donor utilization, nor did it increase the personnel cost of the center, says Dr. Osselaer. “With pathogen inactivation, we avoided the cost of gamma irradiation and routine bacterial cultures. In addition, we were able to extend the shelf-life of platelets to 7 days, which reduced the overall platelet wastage rate significantly. Furthermore, its potential to reduce patient care costs thanks to the reduction of acute transfusion reactions is a health benefit to the recipient, but also an economical benefit to society.”
He also is clear about patient safety: “INTERCEPT seems to produce a safer platelet product for patients. During the five years prior to delivering pathogen inactivated platelets, we registered 2 cases of sepsis. Since the use of INTERCEPT we have not registered any. In addition, the reduction in transfusion reactions has been a real benefit, and we are encouraged that the Etablissement Français du Sang d’Alsace (EFS) in Strasbourg has come to the same conclusion. We are working together with a French immunology lab to determine why this benefit is being seen.”
Dr. Osselaer is currently extending his research experience to a five-year period, evaluating 15,000 apheresis platelet doses treated with INTERCEPT.
Examining the Logical Choice for Blood Safety
Five years after making the decision to implement INTERCEPT, Dr. Osselaer is even more convinced of the benefits of pathogen inactivation. “The limits of bacterial detection are seen more today than ever. Late sampling increases the number of positive units by three-fold, but it is impossible to handle from a logistical standpoint. Early sampling is logistically feasible, but completely inadequate for ensuring blood safety. The logical choice for blood safety lies in pathogen inactivation, not in bacterial screening.”
Dr. Osselaer is as much a scientist as a medical practitioner. He recently published an article in Transfusion comparing platelet and red cell utilization during the 3-year period before and after routine use of INTERCEPT platelets was established. The goal was to assess the impact of this new technology on component utilization under routine clinical practice conditions in a broad patient population, including many hematology-oncology patients. To do this, he analyzed hemovigilance data documenting production, utilization and clinical outcomes.
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