Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery (Hemopatch)
Primary Purpose
CHD - Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Medical Device Hemopatch-PEG-coated collagen patch
Sponsored by
About this trial
This is an interventional treatment trial for CHD - Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- coronary heart disease CHD (mammary harvesting)
- age>18
- informed consent
Exclusion Criteria:
- any condition that exclude patient from standard CABG procedure
- additional cardiac procedure to be conducted on subject in addition to CABG
Sites / Locations
- Medical University of LodzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Second group of patients will undergo standard CABG procedure in CPB only.
Outcomes
Primary Outcome Measures
Total postoperative drainage (ml)
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
need for blood transfusion (number of blood units transfused)
the total amount of blood passed to the patient
The number of reoperations
The necessity of performing retoractomy due to excessive drainage or cardiac tamponade
Secondary Outcome Measures
level of hemoglobin (g/dl)
level of hemoglobin tested in perioperative time frame
length of Intensive Care Unit stay (h)
length of Intensive Care Unit stay measured in hours
hospital stay (days)
length of hospital stay after surgery
treatment cost (USD)
total treatment cost measured in both experimental and control group from hospital admission to hospital discharge
Full Information
NCT ID
NCT03340090
First Posted
October 26, 2017
Last Updated
August 8, 2019
Sponsor
Medical University of Lodz
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03340090
Brief Title
Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
Acronym
Hemopatch
Official Title
Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz
Collaborators
Baxter Healthcare Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent haemorrhage after IMA harvesting and sternum closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHD - Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomized groups of 100 patients will undergo standard CABG procedure in Cardio-Pulmonary Bypass (CPB). In first group (100 patients) two pieces of Hemopatch will be applied in one patient. Second group is the control group without above described intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Second group of patients will undergo standard CABG procedure in CPB only.
Intervention Type
Device
Intervention Name(s)
Medical Device Hemopatch-PEG-coated collagen patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total postoperative drainage (ml)
Description
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
Time Frame
measured 48 hours after surgery
Title
need for blood transfusion (number of blood units transfused)
Description
the total amount of blood passed to the patient
Time Frame
measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
Title
The number of reoperations
Description
The necessity of performing retoractomy due to excessive drainage or cardiac tamponade
Time Frame
observed until 7 days after surgery
Secondary Outcome Measure Information:
Title
level of hemoglobin (g/dl)
Description
level of hemoglobin tested in perioperative time frame
Time Frame
after surgery until hospital discharge (on avarage until 7th day after surgery)
Title
length of Intensive Care Unit stay (h)
Description
length of Intensive Care Unit stay measured in hours
Time Frame
on average 48 hours after surgery
Title
hospital stay (days)
Description
length of hospital stay after surgery
Time Frame
after surgery until hospital discharge (on average until 7th day after surgery)
Title
treatment cost (USD)
Description
total treatment cost measured in both experimental and control group from hospital admission to hospital discharge
Time Frame
from patient hospital admission to hospital discharge ( on average 8-10 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary heart disease CHD (mammary harvesting)
age>18
informed consent
Exclusion Criteria:
any condition that exclude patient from standard CABG procedure
additional cardiac procedure to be conducted on subject in addition to CABG
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michał Krejca, PhD,Md
Phone
+48422014460
Email
michal.krejca@umed.lodz.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Skowronski, Md
Phone
+48422014467
Email
tomek.skowronski@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Krejca, PhD, Md
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Lodz
City
Łódź
State/Province
Lodzkie
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Krejca
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
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