Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Not Applicable

Completed

• Conditions: Bleeding
• Interventions: Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar); Device: Hemopatch

• Registration Number: NCT02133378
• Lead Sponsor: Cardiochirurgia E.H.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Traditional Hemostasis Techniques (dry or wet gauze compression or similar)	Traditional techniques hemostasis (dry or wet gauze compression or similar)
Hemopatch	Hemopatch	Use of Hemopatch on bleeding spot

Primary Outcome Measures

Name	Time	Method
Percentage of Successful Hemostasis in under 3 minutes	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

Secondary Outcome Measures

Name	Time	Method
Post Operative Blood Loss	6 hours	Blood loss in the first 7 hours postoperatively

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Italy