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The Journal of Thoracic and Cardiovascular Surgery, Vol 97, 194-203, Copyright © 1989 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
J Rousou, S Levitsky, L Gonzalez-Lavin, D Cosgrove, D Magilligan, C Weldon, C Hiebert, P Hess, L Joyce and J Bergsland
A multicenter study was conducted to test the efficacy and safety of fibrin
sealant as a topical hemostatic agent in patients undergoing either
reoperative cardiac surgery (redo) or emergency resternotomy. A total of
333 patients from 11 centers in the United States were included in the
study. Patients were randomly assigned to initially receive the fibrin
sealant or a conventional topical hemostatic agent when such was required
during an operation. The end point used to evaluate the agent's efficacy
was local hemostasis, the number of bleeding episodes controlled within 5
minutes. The fibrin sealant group from the prospective study was compared
with historical matched control subjects for postoperative blood loss, need
for resternotomy, blood products received, and hospital stay. It was also
compared with historical nonmatched control subjects for the incidence of
resternotomy and mortality. The results showed a 92.6% success rate for
fibrin sealant in controlling bleeding within 5 minutes of application,
compared with only a 12.4% success rate with conventional topical agents (p
less than 0.001). Fibrin sealant also rapidly controlled 82.0% of those
bleeding episodes not initially controlled by conventional agents.
High-volume postoperative blood loss was significantly less (p less than
0.05) in the fibrin sealant group than in the matched controls.
Additionally, resternotomy rates after redo operations were significantly
lower in the fibrin sealant group (5.6%) than in the nonmatched historical
control group (10%) (p less than 0.0089). There were no significant
differences in hospital stay or blood products received between the fibrin
sealant group and matched historical controls and no difference in
mortality between the fibrin sealant group and nonmatched historical
controls. There were no documented instances of adverse reactions,
transmission of viral infection (hepatitis B, non-A/non-B hepatitis), or
human immunodeficiency virus seroconversion. This study shows that fibrin
sealant is safe and highly effective in controlling localized bleeding in
cardiac operations. Fibrin sealant reduces postoperative blood loss and
decreases the incidence of emergency resternotomy. These findings make
fibrin sealant a valuable hemostatic agent in cardiac surgery.
ARTICLES
Randomized clinical trial of fibrin sealant in patients undergoing resternotomy or reoperation after cardiac operations. A multicenter study
University of Illinois, Department of Surgery, Chicago 60680.
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