Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Cardiochirurgia E.H.

Status: Completed

Conditions: Bleeding

Treatments: Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar); Device: Hemopatch

Study type: Interventional

Funder types: Other

Identifiers

NCT02133378

2014-01

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgery on Ascending Aorta with Dacron Graft or transverse Aortotomy
• Moderate bleeding

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Hemopatch

Experimental group

Description:

Use of Hemopatch on bleeding spot

Treatment:

Device: Hemopatch

Control

Sham Comparator group

Description:

Traditional techniques hemostasis (dry or wet gauze compression or similar)

Treatment:

Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)