Clinical Evidence

Controlled Prospective Clinical Trial^1-3
N=309; Cardiac/Vascular/Spinal-Orthopaedic Surgery

A controlled randomised multicenter clinical study was performed including patients with intraoperative bleeding from three specialties: Cardiac, Vascular and Spinal Surgery.^2-4

309 patients were randomised after bleeding was identified to either FLOSEAL or thrombin-soaked GELFOAM (Control). Primary endpoint was haemostasis within 10 minutes at the first bleeding site. Success was defined as haemostasis within 10 minutes and bleeding was checked at 1, 2, 3, 6, and 10 minutes.² Bleeding was rated as "oozing," "flowing," or "pulsatile," with approximately one-third of the patients falling into the latter two categories.

FLOSEAL stopped bleeding more effectively than the control at each point in time monitored. The time to haemostasis was significantly shorter with FLOSEAL, especially in the category "heavy bleeding" (flowing + pulsatile) FLOSEAL was faster and more effective than control.

1. Data on file. Deerfield, Ill: Baxter International Inc.
2. Oz MC, Cosgrove DM, Badduke BR, et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg. 2000;69(5):1376-82.
3. Oz MC, Rondinone JF, Shargill NS. FLOSEAL matrix: New generation topical hemostatic sealant. J Card Surg 2003;(18):6:486-93.
4. Weaver FA, Hood DB, Zatina M, Messina L, Badduke B. Gelatin-thrombin based hemostatic sealant for intraoperative bleeding in vascular surgery. Ann Vasc Surg. 2002;16(3):286-93.