Elsevier

The Annals of Thoracic Surgery

Volume 88, Issue 5, November 2009, Pages 1520-1526
The Annals of Thoracic Surgery

Original article
Adult cardiac
Prospective, Randomized Clinical Trial of the FloSeal Matrix Sealant in Cardiac Surgery

https://doi.org/10.1016/j.athoracsur.2009.07.014Get rights and content

Background

Topical hemostatic agents composed of a gelatin-based matrix and thrombin have been reported to be effective, in addition to traditional means, in terminating bleeding during cardiac operations. We compared a hemostatic matrix sealant agent (FloSeal; Baxter Inc, Deerfield, IL) with alternative topical hemostatic agents in a mixed cohort of elective cardiac and thoracic aortic operations.

Methods

Following sample size calculation, in a prospective randomized study design, 209 patients were treated with FloSeal matrix sealant (FloSeal group) and 206 patients received alternative agents as topical hemostatic materials (comparison group). FloSeal is composed of a self-expandable gelatin matrix component and purified bovine thrombin. Comparisons included hemostatic patches or sponges composed of either oxidized regenerated cellulose or purified porcine skin gelatin. Study endpoints were the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.

Results

Statistically higher rates of successful hemostasis and shorter time-to-hemostasis were observed in the FloSeal group (p < 0.001 both). Time-to-event analysis confirmed this finding (p = 0.0025). Postoperative bleeding and rate of transfusion of blood products were statistically decreased in the FloSeal group (p < 0.001 both). Rates of revision for bleeding and of minor complications were not statistically different among groups in the overall cohort, but were significantly lesser in the FloSeal group if only patients with overt intraoperative bleeding are considered (p = 0.04 both). The advantages observed in the FloSeal group were not offset in patients undergoing systemic hypothermia.

Conclusions

The topical hemostatic agent used in the FloSeal group is effective in terminating intraoperative bleeding as an adjunct to traditional surgical methods for stopping bleeding. Its judicious use is associated with lesser need for transfusion of blood products and rate of revision for bleeding. Its cost-utility profile should be addressed in dedicated trials.

Section snippets

Patients and Methods

The local Ethical Committee approved the study protocol and the patients enrolled in the study received full information, were willing to enter the trial, and provided written informed consent.

Study outcome measures included the following: rate of successful intraoperative hemostasis and time required for hemostasis; overall postoperative bleeding (as measured by chest tube output and indexed for body surface area); rate of transfusion of blood products both intraoperatively and in the

Results

Study design is summarized in Figure 1. The two study groups were comparable with respect to baseline characteristics as outlined in Table 1. Isolated coronary surgery was the most frequent category of operation performed, but more complex operations (combined coronary and valvular surgery) associated with prolonged cardiopulmonary bypass time, and aortic operations requiring systemic hypothermia were performed in a substantial amount of cases. Systemic hypothermia was indeed employed in 21% of

Comment

The primary objective of this study was to evaluate the intraoperative performance of the FloSeal hemostatic matrix as a topical hemostatic agent in a cohort of various primary cardiac operations. A key element of novelty with respect to the previously published studies is represented by the assessment of the immediate clinical course of the patients with respect to bleeding and bleeding-related complications. A wide variety of topical hemostatic agents have been developed so far, including

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