Fibrin Glue from Stored Human Plasma
An Inexpensive and Efficient Method for Local Blood Bank Preparation
William D. Spotnitz, M.D., Paul D. Mintz, M.D., Nancy Avery, M.T.,
Thomas C. Bithell, M.D., Sanjiv Kaul, M.D., Stanton P. Nolan, M.D.
For complete paper:The American Surgeon 1987;53:460-62
European surgeons have used fibrin glue extensively during thoracic, cardiovascular, and general surgical operations. Until now, however, it has been available only as a commercial preparation made from pooled human plasma, and it has not been approved by the U.S. Food and Drug Administration for use in the United States because of a high associated risk of hepatitis and acquired immune deficiency syndrome. Methods of obtaining fibrinogen, an essential component of fibrin glue, from cryoprecipitate or fresh frozen plasma have been published recently. However, the cryoprecipitate method results in relatively low concentrations of fibrinogen, which can reduce glue effectiveness. The fresh frozen plasma method is more expensive and does not meet the standards of the American Association of Blood Banks for the closed system required for safe handling and management of blood component products. Both the cryoprecipitate and the fresh frozen plasma methods result in waste of unstable clotting factors. These factors are necessary to replace human plasma clotting deficiencies but are not necessary for the production of fibrin glue. The authors have developed an efficient, high-concentration blood bank method for producing and maintaining a local supply of a safer and less expensive but equally effective material derived from stored human plasma. This material is produced using approved blood bank techniques for a closed system in blood component production, thus reducing the risks of contamination and infection, and its fibrinogen concentration is higher than that of a standard cryoprecipitate. The cost for 1 unit of this fibrin glue is comparable to that for 1 unit of cryoprecipitate and less than that for 1 unit of fresh frozen plasma. The stored plasma method avoids waste of valuable unstable clotting factors, and the final product can be stored frozen for periods of up to 5 years.
Whole blood is collected from healthy volunteer donors in accordance with current standards of the American Association of Blood Banks and the FDA. A triple of quadruple blood pack system containing either CPD or CPDA-1 anticoagulant is used for the collection. Each unit is serologically screened for hepatitis B surface antigen and for HTLV-III antibody.
Whole blood that has been stored for 1 to 10 days at 1 – 6 C is centrifuged and the plasma transferred to one of the integral satellite packs (Fenwall 4R1916 Blood Collection Packs, Travenol Laboratories, Deerfield, MI) using routine packed-cell preparation methods. A second satellite pack and the bag containing the plasma are separated from the packed cells and placed in a freezer at -80 C for at least 24 hours. After 24 hours, the frozen plasma is placed in a standard blood bank refrigerator at 1 – 6 C and thawed for 12 hours. The white precipitate that forms in the plasma bag is then concentrated by centrifugation at 6500 x g for 5 minutes at 4 C. The supernatant plasma is carefully transferred to the second integral satellite pack, and the remaining material is the fibrinogen-rich concentrate. The two bags are then sealed and separated.
The fibrinogen-rich concentrate (approximately 10 cc derived from 250 cc of plasma), labeled appropriately, is available for immediate use, or it may be refrozen at -30 C for storage for up to 5 years. The frozen fibrinogen concentrate can be removed from the freezer and thawed in a circulating water bath at 37 C in 10 minutes. This thawed concentrate can be made available for immediate use or stored up to 5 days in a standard blood bank refrigerator. Once the seal on the bag is broken, the product should be discarded within 24 hours.
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