Panel calls for curbing use of fresh frozen plasma Essay

Fresh frozen plasma is being widely overused as a therapeutic agent,
and “innovative educational efforts” aimed at physicians are
needed to stem the sharply increased risk of spreading infectious
disease through this blood product’s unwarranted use.



Medical and blood banking specialists attending a recent three-day
consensus conference offered those conclusions in a draft report and
press briefing immediately following the meeting. The National
Institutes of Health and the Food and Drug Administration convened the
gathering expressly to examine issues surrounding the growing
professional concerns about FFP indications, effectiveness, and safety.

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The 11-member panel that authored the post-conference statement and
conclusions was emphatic. FFP administration, it said, has increased
dramatically in recent years “despite the paucity of definitive
indications for its use” and “in the presence of mounting
evidence of its potential risks,” including viral hepatitis and
possibly AIDS.



Many patients who receive FFP can be managed “more effectively
and safely with alternative modalities,” the panel said, noting
that FFP use “must be justified on clinical grounds until better
evidence is available.”



The panel also pointedly criticized one practice. “There is
no justification for the use of FFP as a volume expander. Safer
alternative therapy exists.”



The most appropriate indications for FFP, the panel said, are:


* some documented protein deficiencies;



* selected patients who require massive transfusions;



* patients with multiple coagulation defects as in liver disease;



* in conjunction with therapeutic plasma exchange for thrombotic
thrombocytopenic purpura;



* infants with protein-losing enteropathy; and



* selected patients with other immune deficiencies.



“Its use in most other cases should be discouraged,” the
report concluded.



Translated to percentages, the picture is more graphic. Harvard
medical school professor emeritus Dr. James Tullis, the panel chairman,
estimated that 90 per cent of current FFP use is inappropriate. Figures
supplied by researchers at the conference indicate that some 700,000
patients a year are receiving 1.8 million units of FFP–a tenfold
increase over the last five years.



During the same period, while little apparently was done to define
specifications for therapeutic applications, blood product specialists
came to realize that risk of disease transmission through FFP had become
“significant.” Panel members referred to one estimate that
perhaps 20,000 to 70,000 cases of viral hepatitis are transmitted each
year through FFP. They also cited studies indicating that the incidence
of non-icteric and icteric hepatitis following multiple transfusions of
whole blood or red blood cells is between 3 and 10 per cent. They
believe the range for transfusions with FFP is likely the same.



The panelists said most of the misuse probably occurs in replacing
blood lost during cardiac surgery, while a second troublesome practice
is combining plasma with red blood cells when other combining fluids
could be used with less risk.



Dr. Scott Swisher, a Michigan State University medical professor
who addressed the conference, reported that American Red Cross records
showed that FFP went largely to tertiary care, high-technology
hospitals.



University medical centers, university-affiliated hospitals, and VA
facilities represent 4.31 per cent of the hospitals served by the Red
Cross, yet received 25.8 per cent of the FFP distributed, he said. In
contrast, general and speciality hospitals ordered FFP in “direct
proportion” to their representation: 69.4 per cent of FFP to 72.8
per cent of facilities served. And investor-owned, military, and Public
Health Service hospitals received less FFP than their representation on
the roster.


What accounts for this blood product’s popularity if, as the
report noted, little in the literature supports its increased use in
clinical medicine?



“The trend may be attributable, in part, to a decreased
availability of whole blood due to widespread acceptance of the concept
of component therapy,” the panel’s statement said.



Other contributing factors mentioned during the conference but not
included in the summary document included the high cost of some
alternatives, limited knowledge among clinicians about scientifically
sound transfusion practices, and inadequate instruction of medical
school students and residents.



Some questioned whether clinical laboratory directors, hospital
transfusion service chiefs, and blood bank directors always have access
to or comply with the latest scientific opinion, or whether they at
times promote FFP use because the product is a revenue generator. Also
cited: the accepted medical practice of administering component-loaded
plasma rather than determining and ordering the specific components a
patient needs.



As for alternatives, the panel said the most important is a
comprehensive program of blood conservation. This includes measures
such as autologous donations before elective surgery, the use of cell
savers, reinfusion of shed blood, “and the realization that in many
patients normovolemic anemia is not life-threatening.”



Added the panel: “Single-donor plasma is efficacious in
treating mild deficiencies of stable clotting factors” and “of
value for multiple deficiencies, as in reversal of warfarin effects or
in liver disease …. Cryoprecipitate should be used when fibrinogen or
von Willebrand factor is needed. For treatment of hemophilia A,
cryoprecipitate of factor VIII concentrates, heated or unheated, are
available. For hemophilia B, factor IX complex is preferable ….
Albumin, plasma protein fraction, crystalloid solutions, hydroxyethyl
starch, or dextran are preferable to FFP for volume replacement. Whole
blood or blood modified by removal of the platelets and cryoprecipitate
should be used if available, rather than the combined administration of
plasma and red blood cells.”



The panel noted that FFP use is controlled locally and determined
largely by existing practice. “Attempts to alter FFP use
frequencly have been ineffective,” it pointed out. But where
successful, a “strong local proponent of modern transfusion
practices” is usually found.



“Ongoing collaborative efforts, including component therapy
workshops involving clinicians and blood bank directors, can do much to
alter existing practices,” it advised. “Increased attention
to the risks and benefits of component therapy in the medical schools
and teaching hospitals also may change FFP use.”



When appropriate, information regarding FFP’s potential risks
and benefits, as well as those for other blood products, should be made
available to patients who receive them, the panel said.



The report also provided a lengthy list of recommended future
research goals, including:



* A national prospective epidemiologic study to identify the
current usage patterns of FFP and related products.



* Defining the etiology of uncontrollable hemorrhage in the
massively transfused patient.



* Clinical investigations to identify the factor(s) in fresh frozen
plasma that appears to cause beneficial effects in patients who are
undergoing apheresis for treatment of syndromes such as thrombotic
thrombocytopenic purpura.



* Blood salvage during operative procedures to allow a more
judicious use of FFP and other blood products.



* Production of the safest possible FFP or substitutes.



* Technology involving membrane-separation techniques to separate
cellular products more effectively.



* Development of an efficient system by which a larger volume of
FFP can be collected from a single donation, thus lessening the number
of donor exposures.



At this writing, panel participants were reviewing the draft
document, and a final version was to have been published late last
month. Some close to the working group expected only minor wording
changes, while others anticipated considerable rewriting. No one,
however, predicted major substantive changes since no major rifts
emerged among the specialists during the conference.



Meanwhile, a Red Cross spokesman said the ARC fully supported the
draft. Officials at the American Association of Blood Banks elected to
withhold comment until the final version was available.

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