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Completed

NCT Number: NCT02133378

Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

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.

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Key information

Conditions

Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital

Rome, 00151, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

HEMOPATCH

Device

Baxter Hemopatch

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

Behavioral

Primary outcomes

  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 outcomes

  1. Post Operative Blood Loss

    Time frame: 6 hours

    Blood loss in the first 7 hours postoperatively

Other outcomes

  1. Allogeneic Blood Transfusion

    Time frame: 4 days

    Allogeneic Blood Transfusion in the first 4 days after surgery

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 8, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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