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Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02133378
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Luca Weltert, 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.

Condition or disease Intervention/treatment
Bleeding Device: Hemopatch Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery.
Study Start Date : March 2014
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Hemopatch
Use of Hemopatch on bleeding spot
Device: Hemopatch
Baxter Hemopatch
Sham Comparator: Control
Traditional techniques hemostasis (dry or wet gauze compression or similar)
Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Primary Outcome Measures :
  1. Percentage of Successful Hemostasis in under 3 minutes [ Time Frame: 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 :
  1. Post Operative Blood Loss [ Time Frame: 6 hours ]
    Blood loss in the first 7 hours postoperatively

Other Outcome Measures:
  1. Allogeneic Blood Transfusion [ Time Frame: 4 days ]
    Allogeneic Blood Transfusion in the first 4 days after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133378

European Hospital
Rome, Italy, 00151
Sponsors and Collaborators
Cardiochirurgia E.H.

Responsible Party: Luca Weltert, Dr. Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT02133378     History of Changes
Other Study ID Numbers: 2014-01
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Luca Weltert, Cardiochirurgia E.H.:

Additional relevant MeSH terms:
Pathologic Processes