Facilitating Hemostasis After Proximal Aortic Surgery: Results of The PROTECT Trial.

BACKGROUND

This study intended to evaluate the safety and hemostatic efficacy of a novel vascular sealant (Tridyne; Neomend, Inc, Irvine, CA) compared with an accepted adjunctive hemostatic agent applied to aortotomy and sutures lines in cardiovascular operations.

METHODS

Patients undergoing aortic valve replacement, ascending aortic replacement, or aortic root replacement were randomly assigned 2:1 to Tridyne (n = 107) or Gelfoam Plus (Baxter Healthcare Corp, Hayward, CA) (n = 51). These groups were similar with regard to age, sex, race, medical history, duration of bypass and cross-clamping, and number of suture lines treated. Suture lines were treated after confirmation of some leakage but before formal removal of the clamp.

RESULTS

The median bleeding time was significantly lower for Tridyne versus Gelfoam Plus (0 versus 10.0 minutes, p < 0.0001). Immediate hemostasis was achieved in 59.4% of the Tridyne group versus 16.0% of Gelfoam Plus group (p < 0.0001). A significantly greater proportion of patients in the Tridyne group achieved successful hemostasis at the aortic suture line than patients in the Gelfoam Plus group (85.7% versus 40.0%, p < 0.0001). The Clinical Events Committee adjudicated 7 patients with possible device-related serious adverse events: 3 patients (2.9%) in the Tridyne group and 4 patients (8.2%) in the Gelfoam Plus group (p = 0.2097).

CONCLUSIONS

Tridyne was safe and effective when used as an adjunct to conventional hemostasis to treat high-pressure vessels in patients who receive anticoagulation agents, in reducing time to hemostasis, and in promoting both immediate and persistent hemostasis.