Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133378
• Other study ID #: 2014-01
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: September 13, 2017
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2017
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Surgery on Ascending Aorta with Dacron Graft or transverse Aortotomy

• Moderate bleeding

Exclusion Criteria:

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Device:
• Hemopatch
Baxter Hemopatch

Behavioral:
• Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Allogeneic Blood Transfusion	Allogeneic Blood Transfusion in the first 4 days after surgery	4 days
Primary	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	Post Operative Blood Loss	Blood loss in the first 7 hours postoperatively	6 hours