Plasma is the aqueous part of blood containing proteins and salt in which red and white blood cells and platelets are suspended. It constitutes approximately 55 percent of total blood volume. Important elements in plasma include albumin, coagulation factors, fibrinolytic proteins, immunoglobulin and other proteins.
Plasma usually is frozen within hours of donation in order to preserve the clotting factors. Frozen plasma products have a 12-month life span and are transfused within 24 hours of thawing. Plasma products are indicated for use in several treatments, including to treat bleeding disorders when a patient is deficient in one or multiple clotting factors and no factor-specific concentrate is available, and initial treatment of patients who are undergoing massive transfusion because of life-threatening trauma/hemorrhages and who have clinically significant coagulation deficiencies. Some plasma products are not used for direct transfusion but are shipped for further manufacture where they are separated into specific products, including albumin, clotting factors and intravenous immune globulin.
AABB works on behalf of donors and patients to ensure the safe and effective collection, processing and use of plasma. In performing this work, the association communicates directly with federal agencies, including the Food and Drug Administration and the Centers for Medicare and Medicaid Services, advocating for appropriate guidance, regulations and reimbursement for plasma. AABB also has worked on behalf of the community to gain recognition and licensure of recovered plasma for further manufacture.
AABB updated the Circular of Information web page to include new language required by the Food and Drug Administration for the manufacture of cryoprecipitated antihemophilic factor (AHF) manufactured from plasma frozen within 24 hours after phlebotomy (PF24).
Scott Gottlieb, MD, commissioner of the Food and Drug Administration (FDA), and Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, issued a statement of caution in response to reports that facilities in several states are offering plasma infusions from young donors as treatment for a variety of conditions.
December 13, 2023
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October 19, 2023