Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Bleeding

Intervention / Treatment
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* Device: Hemopatch
* Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgery on Ascending Aorta with Dacron Graft or transverse Aortotomy Moderate bleeding Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemopatch<br>Use of Hemopatch on bleeding spot | Device: Hemopatch<br>* Baxter Hemopatch<br>|
| Sham Comparator: Control<br>Traditional techniques hemostasis (dry or wet gauze compression or similar) | Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Successful Hemostasis in under 3 minutes | Application of Hemopatch or traditional techniques (compression with dry or wet gauze or similar) are considered successful if hemostasis is reached in under 3 minutes | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Blood Loss | Blood loss in the first 7 hours postoperatively | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding, Hemostatic