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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
BACKGROUND
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.
METHODS
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.
Copyright © J.B. Lippincott Co.
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