Development of a Highly Efficient Adsorber to Remove Anti-A and Anti-B Antibodies from Blood and Plasma for Transfusion
Abstract
Blood is typed into four major groups, A, B, AB, and O, depending on the presence or absence of the A or B antigens on a person’s red blood cells. Anti-A and/or anti-B antibodies are found in the plasma of people that don’t carry A or B antigens that can break open the red blood cells of a mismatched donor; therefore, blood products must be appropriately matched in transfusions to prevent serious and life-threatening reactions. Plasma from AB donors is considered “universal” as it can be transfused regardless of the recipient’s blood type and is frequently used to rapidly save massively bleeding hospital trauma patients and Warfighters with combat casualties. However, supply shortages are common as AB donors make up only 4% of the population. Likewise, whole blood from O-type donors can be transfused universally if the amount of anti-A or anti-B antibodies in the donor’s plasma is low, i.e., low titer O whole blood (LTOWB); however, this requires additional donor testing that may not be practicable in an emergency. Therefore, a robust technology to cost-effectively generate universal plasma from any donor or LTOWB from any O donor is of great importance. To address this, we propose the development of a small, light-weight device based on CytoSorbents’ unique and powerful blood filtration and purification technology to remove anti-A and anti-B antibodies from plasma and whole blood. The outcome will be the development of a safe, easy-to-use device that can simplify blood handling and storage, reduce transfusion costs, and eliminate risk from transfusion errors caused by ABO mismatching to benefit patients treated at emergency trauma centers and advanced military medical units. The proposed blood group antibody adsorber directly addresses the hemorrhage control focus area for the development of innovative damage control resuscitation capabilities to reduce the mortality and morbidity associated with major combat-related trauma. This proposal addresses the needs across the spectrum of emergency care including field resuscitation and advanced surgical care and hospital-based care. Medics treating causalities far forward or during transport could utilize the device to rapidly reduce the BGA antibodies in blood from “walking blood bank” donors for hemorrhage control and resuscitation. Additionally, antibody depleted blood shipped from the continental U.S. could be administered at any stage in theater or used stateside in civilian or Veteran’s Administration hospitals to resuscitate hemorrhaging surgical or trauma patients. CytoSorbents’ overall plan is to have a commercial ready BGA adsorber, prepared for U.S. Food and Drug Administration (FDA) approval and subsequent transition for deployment to far-forward military and disaster environments, Armed Services, and civilian blood centers. The readily portable antibody adsorber rapidly and efficiently adsorbs blood group antibodies from whole blood as well as plasma to increase the availability of these life-saving resources particularly in far-forward combat operations that might otherwise not be possible. Increased availability of universal blood products will allow military efforts to more readily get the right blood to the right place at the right time in the right amount. Military blood product depots would no longer have to stock multiple blood type units for each product, making storage and distribution easier while avoiding the risk of transfusing incorrectly matched blood. Furthermore, it would enable medical personnel to provide medical intervention to bleeding patients immediately when blood transfusion has the greatest chance of saving lives. CytoSorbents’ mature manufacturing capability reduces program risk, ensuring that the product will be available to the military expediently and at reasonable costs.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010712
Entities
People
- Maryann C Gruda
Organizations
- CytoSorbents (United States)
- United States Army