Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Sponsor

Cardiochirurgia E.H. (Other)

Overall Status

Completed

CT.gov ID

NCT02133378

Collaborator

(none)

170

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Bleeding	Device: Hemopatch Behavioral: Traditional Hemostasis Techniques (dry or wet gauze compression or similar)	N/A

Study Design

Study Type:

Interventional

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 :

Mar 1, 2014

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Post Operative Blood Loss [6 hours]
Blood loss in the first 7 hours postoperatively

Other Outcome Measures

Allogeneic Blood Transfusion [4 days]
Allogeneic Blood Transfusion in the first 4 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	European Hospital	Rome		Italy	00151

Sponsors and Collaborators

Cardiochirurgia E.H.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Nasso G, Piancone F, Bonifazi R, Romano V, Visicchio G, De Filippo CM, Impiombato B, Fiore F, Bartolomucci F, Alessandrini F, Speziale G. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg. 2009 Nov;88(5):1520-6. doi: 10.1016/j.athoracsur.2009.07.014.

Responsible Party:

Luca Weltert, Dr. Luca Weltert, Cardiochirurgia E.H.

ClinicalTrials.gov Identifier:

NCT02133378

Other Study ID Numbers:

2014-01

First Posted:

May 8, 2014

Last Update Posted:

Sep 14, 2017

Last Verified:

Sep 1, 2017

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

Bleeding

Hemostatic

Additional relevant MeSH terms:

Hemorrhage

Hemostatics

Study Results

No Results Posted as of Sep 14, 2017