LifeShare Blood Center has received FDA Licensure approval for Apheresis Platelets stored in InterSol Platelet Additive Solution (PAS)

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LifeShare Blood Center has received FDA Licensure approval for Apheresis Platelets stored in InterSol Platelet Additive Solution (PAS). This approval expands LifeShare’s ability to distribute apheresis platelets containing PAS outside the state of Louisiana.

InterSol solution is designed to replace a proportion of the plasma used in the storage of leukoreduced apheresis platelets under standard blood banking conditions. Studies have shown that an adverse event rate of 0.55% for InterSol platelets as compared to 1.37% in plasma platelets. Some patients who receive platelet transfusions have reactions to the plasma in the platelets. By reducing the amount of plasma, the risk of reaction is also reduced. Data from current studies shows transfusions with PAS platelets reduce the risk of transfusion‐related reactions by approximately 65%.

The PAS apheresis platelet license approval is issued by the U.S. Food and Drug Administration (FDA), the regulatory agency for all blood centers that operate in the United States.

LifeShare Blood Center, established in Shreveport, La. in 1942, regularly supplies blood components and related services to more than 100 medical facilities and hospitals throughout Louisiana, East Texas and South Arkansas. LifeShare is a member of America’s Blood Centers and the American Rare Donor Program, is licensed by the U.S. Food & Drug Administration, and accredited by AABB. LifeShare Blood Center is a 501(c)(3) nonprofit community blood bank governed by a volunteer Board of Trustees.

References:

  • A comparison of adverse reaction rates for PAS C versus plasma platelet units. Cohn et al. Transfusion 2014.
  • In vitro and in vivo evaluation of apheresis platelets stored for 5 days in 65% platelet additive solution/35% plasma. Vassallo et al. Transfusion 2010.
  • A comparison of adverse reaction rates for PAS C versus plasma platelet units. Cohn et al. Transfusion 2014.
  • The impact of platelet additive solution apheresis platelets on allergic transfusion reactions and corrected count increment. Tobian et al. Transfusion 2014.
  • Prevention of allergic transfusion reactions to platelets and red blood cells through plasma reduction. Tobian et al. Transfusion 2011.
  • The cost‐effectiveness of platelet additive solution to prevent allergic transfusion reactions. Kacker et al. Transfusion 2013.
  • Abstract SP343: Post PAS 3 launch reaction rates (RR) and increments at North Shore University Hospital (NSUH). Heaton et al. Transfusion 2013.
  • Abstract SP232: Transfusion reaction rates are reduced with platelet units stored in platelet additive solution. Cohn et al. Transfusion 2011.
  • Abstract SP388 First experiences transfusing platelets produced with additive solution. Becker. Transfusion 2011