Bleeding Clinical Trial
Official title:
Prospective, Randomized Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery.
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.
n/a
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