NCT02133378

Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Prospective, Randomized Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Cardiochirurgia E.H. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. The investigators compared such hemostatic agent (Hemopatch; Baxter Inc, Deerfield, IL) with traditional optimized hemostasis routine. Following sample size calculation, in a prospective randomized study design, 100 patients will be treated with Hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group). To make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of Dacron grafts to ascending aorta or moderately bleeding transversal aortotomy. Study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) 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.

Conditions

• Bleeding

Interventions

Type	Name	Description
DEVICE	Hemopatch	Baxter Hemopatch
BEHAVIORAL	Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-05-08
• Last updated: 2017-09-14

Locations

1 site across 1 country: Italy