Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

NCT ID: NCT02133378

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hemopatch

Use of Hemopatch on bleeding spot

Group Type: EXPERIMENTAL

Hemopatch

Intervention Type: DEVICE

Baxter Hemopatch

Control

Traditional techniques hemostasis (dry or wet gauze compression or similar)

Group Type: SHAM_COMPARATOR

Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Intervention Type: BEHAVIORAL

Interventions

Hemopatch

Baxter Hemopatch

Intervention Type: DEVICE

Traditional Hemostasis Techniques (dry or wet gauze compression or similar)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiochirurgia E.H.

OTHER

Sponsor Role: lead

Responsible Party

Luca Weltert

Dr. Luca Weltert

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

European Hospital

Rome, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 19853105 (View on PubMed)

Other Identifiers

2014-01

Identifier Type: -

Identifier Source: org_study_id