Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133378

Enrollment

170

Registered

2014-05-08

Start date

2014-03-31

Completion date

2015-03-31

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding

Keywords

Bleeding, Hemostatic

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.

Interventions

DEVICEHemopatch

Baxter Hemopatch

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Post Operative Blood Loss	6 hours	Blood loss in the first 7 hours postoperatively

Other

Measure	Time frame	Description
Allogeneic Blood Transfusion	4 days	Allogeneic Blood Transfusion in the first 4 days after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026