Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

NCT02133378 | Completed

• 1 other identifier: 2014-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

Bleeding; Hemostatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post Operative Blood Loss

  6 hours

Other Outcomes (1)

• Allogeneic Blood Transfusion

  4 days

Study Arms (2)

Hemopatch

EXPERIMENTAL

Use of Hemopatch on bleeding spot

Device: Hemopatch

Control

SHAM COMPARATOR

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

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

Interventions

Hemopatch DEVICE

Baxter Hemopatch

Hemopatch

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

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Cardiochirurgia E.H.: lead

Study Sites (1)

European Hospital

Rome, 00151, Italy

Location

Related 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.

  PMID: 19853105 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Desiccation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Luca Weltert

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 8, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

IT (1)