ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, September 28, 1996 TAG: 9609300046
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: CARYLE MURPHY THE WASHINGTON POST
NOTE: Below
FIBRIN SEALANT has been used in other countries for years to stop blood loss, but is not yet for sale in America.
As he prepares for surgery, Dr. William Spotnitz orders some of his favorite home brew.
When rivulets of blood pour from his delicate cuts on the human heart, Spotnitz grabs the potion and sprays. Within seconds, the bleeding stops.
Spotnitz, a heart surgeon at the University of Virginia's Health Sciences Center in Charlottesville, has been making his blood-stopping spray for more than a decade because he cannot buy it in the United States.
The agent is fibrin sealant, also more glibly called ``biologic super glue.'' It is a concentrated combination of parts of blood that cause clotting, and it forms a pliable seal that can stop bleeding and help heal wounds.
Fibrin sealant has been available for more than a dozen years in Europe and is also used in Japan, Canada and South America. But U.S.-based drug companies have been slower to develop fibrin sealant products and are only now seeking approval for the products from the U.S. Food and Drug Administration.
Because the sealant is made from blood products, the fear of inadvertent transmission of blood-born viruses was one concern, physicians said. In addition, sealants are ``definitely a new class of product'' used primarily in surgery, where it is difficult to run the stringent clinical trials that the FDA requires to show a product is effective and safe, said Mary Thomas, spokeswoman for Baxter Health Care Corp., which has submitted a sealant for FDA approval.
Several factors have prompted U.S. firms to submit products for FDA approval, researchers said. Europe has had success with fibrin sealants in reducing blood loss. New techniques have improved the ability to detect and inactivate blood-borne viruses. And the $250 million market abroad has shown the moneymaking potential for ``super glues.''
Fibrin sealants are made primarily from thrombin and fibrinogen, proteins found naturally in blood. When combined, they produce a stringy mesh of protein called fibrin that seals blood vessels as part of the clotting process and eventually stops blood loss.
In an operating room, concentrates of thrombin and fibrinogen are combined much like resin and hardener in epoxy glue. The mixture gradually changes from liquid to a jelly-like substance and finally to a hardened gelatin. The hardening can be slowed or quickened depending on the amount of thrombin used; the more thrombin, the faster it hardens. And the more fibrinogen used, the stronger the ``glue.''
``This is why it's such a flexible and wonderful material,'' Spotnitz said.
``It's been used in Europe with no adverse effects, and it's a very, very useful product,'' said Stanley Levitsky, professor of surgery at Harvard Medical School and chief of cardio-thoracic surgery at New England Deaconess Hospital. ``Every other country but the United States is using `biologic glues.' American surgeons have been frantic'' to get it.
During heart surgeries, ``we use large amounts of blood. If I had the glue, I would cover the entire area with it - all the bleeding stops within 30 seconds,'' Levitsky said. Use of sealants, he estimates, could cut the amount of blood needed for a patient by about 75 percent.
It is not illegal to make fibrin sealants for in-house use; it is only illegal to sell or advertise them. Unlike Spotnitz, Levitsky does not favor using homemade sealants because their quality is ``not uniform'' and because of his concern about possible viral transmission.
Col. Barbara Alving, a hematology expert at Walter Reed Army Institute of Research in Washington, D.C., said sealants also curb internal bleeding from organs difficult to suture, such as a damaged liver.
Last fall, the U.S. Army Medical Research and Materiel Command paid $1.1 million to the American Red Cross's Jerome H. Holland Laboratory in Maryland to develop a fibrin sealant bandage. Martin MacPhee, chief investigator for the project, said the bandage will be coated with fibrinogen and thrombin powder. When the bandage is applied to a bloody wound or moist human tissue, the two proteins speed up blood coagulation at the wound.
The Army is interested because in Vietnam, the last war with huge American casualties, 50 percent of battlefield fatalities were the result of excessive bleeding, MacPhee said, adding that if the FDA approves, human clinical trials of the sealant bandage would start in about two years.
Experts said such a bandage could have many uses in civilian medicine, including on-site treatment of traffic accident victims.
LENGTH: Medium: 87 lines ILLUSTRATION: PHOTO: The Washington Post. Surgeon William Spotnitz makes hisby CNBown "biologic super glue" to stop bleeding. color.