Fibrin sealant: summary of a conference on characteristics and clinical uses.
The 2-day conference clearly outlined the formulations of products that are being developed or are commercially available in Europe. The major difference between products in the United States and those in Europe is that US manufacturers are preparing fibrin sealant that does not contain aprotinin, epsilon amino caproic acid, or any other type of antifibrinolytic agent, whereas antifibrinolytic agents are included in all such preparations used in Europe. The conference provided no clear consensus that such agents are essential to the efficacy of the product. Although many investigators believe in the clinical benefit of fibrin sealant, most of the studies to demonstrate efficacy have not been performed in a well-controlled fashion. However, fibrin sealant, if found in a controlled trial to have clinical efficacy, could be approved by the FDA for a narrow indication. Opportunities remain for greater exploration of different forms of the product, not only as a hemostatic agent, but as an adjunct to wound healing and as a matrix for delivery of drugs and proteins with other biologic activities.
Alving
B M
BM
Department of Hematology and Vascular Biology, Walter Reed Army Institute of Research, Washington, DC, USA.
Weinstein
M J
MJ
Finlayson
J S
JS
Menitove
J E
JE
Fratantoni
J C
JC
D000818:Animals; D002986:Clinical Trials as Topic; D015718:Fibrin Tissue Adhesive / Q000737:chemistry / Q000592:standards* / Q000627:therapeutic use*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D015718:Fibrin Tissue Adhesive