Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
NCT ID: NCT03340090
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-03-20
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
First group of patients will undergo standard CABG procedure in CPB. In addition, two pieces of Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of left internal mammary artery (LIMA) harvesting and second piece of Hemopatch will be placed beneath the sternum.
Medical Device Hemopatch-PEG-coated collagen patch
Two pieces of PEG-coated collagen patch Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of LIMA harvesting and second piece of Hemopatch will be placed beneath the sternum.
Control
Second group of patients will undergo standard CABG procedure in CPB only.
No interventions assigned to this group
Interventions
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Medical Device Hemopatch-PEG-coated collagen patch
Two pieces of PEG-coated collagen patch Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of LIMA harvesting and second piece of Hemopatch will be placed beneath the sternum.
Eligibility Criteria
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Inclusion Criteria
* age\>18
* informed consent
Exclusion Criteria
* additional cardiac procedure to be conducted on subject in addition to CABG
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Medical University of Lodz
OTHER
Responsible Party
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Principal Investigators
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Michal Krejca, PhD, Md
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lodz
Locations
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Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Michal Krejca
Role: primary
Other Identifiers
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022017
Identifier Type: -
Identifier Source: org_study_id
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