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Indications and Risks

JAMA. 1985;253(4):551-553.

Abstract
Fresh-frozen plasma (FFP) is defined as the fluid portion of 1 unit of human blood that has been centrifuged, separated, and frozen solid at — 18 °C (or colder) within six hours of collection. Other single-donor plasma units, either frozen or liquid, may be substituted for FFP. Indications for these products are interchangeable with those for FFP except for coagulation factor V deficiency. For that reason, the term FFP in this statement otherwise applies to all single-donor plasma units. The use of plasma and its products has evolved over a period of four decades. The use of FFP has increased tenfold within the past ten years and reached almost 2 million units annually. This trend may be attributable to multiple factors, possibly including decreased availability of whole blood due to widespread acceptance of the concept of component therapy. Fresh-frozen plasma contains the labile as well as the stable components of the coagulation, fibrinolytic, and complement systems; the proteins that maintain oncotic pressure and modulate immunity; and other proteins that have diverse activities. In addition, fats, carbohydrates, and minerals are present in concentrations similar to those in the circulation. Although well-defined indications exist for the use of FFP in single or multiple coagulation deficiencies, indications for many of its other uses may be empiric.

In an effort to resolve some of the questions surrounding the steadily increasing use of FFP, the National Heart, Lung, and Blood Institute, the Center for Drugs and Biologics of the Food and Drug Administration, and the Office of Medical Applications of Research convened a Consensus Development Conference on FFP Sept 24 to 26, 1984. After 1 days of presentations by experts in the field, a consensus panel drawn from the medical professions, blood banking organizations, and the general public considered the evidence and agreed on answers to the following key questions:

1. What are the currently recommended clinical indications for FFP?
   
2. What are the risks of FFP?
   
3. What alternative therapies exist?
   
4. What is the current scientific knowledge regarding the effectiveness of FFP?
   
5. What directions for future research are indicated?
   

Footnotes
From the Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md.

Reprint requests to Office of Medical Applications of Research, Bldg 1, Room 216, National Institutes of Health, Bethesda, MD 20205 (Michael J. Bernstein).

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