Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery

Conditions
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CHD - Coronary Heart Disease

Intervention / Treatment
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* Device: Medical Device Hemopatch-PEG-coated collagen patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: Medical Device Hemopatch-PEG-coated collagen patch<br>* 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.<br>|
| No Intervention: Control<br>Second group of patients will undergo standard CABG procedure in CPB only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative drainage (ml) | total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura) | measured 48 hours after surgery | 
| need for blood transfusion (number of blood units transfused) | the total amount of blood passed to the patient | measeured after surgery until hospital discharge (on avarage until 7th day after surgery) | 
| The number of reoperations | The necessity of performing retoractomy due to excessive drainage or cardiac tamponade | observed until 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of hemoglobin (g/dl) | level of hemoglobin tested in perioperative time frame | after surgery until hospital discharge (on avarage until 7th day after surgery) | 
| length of Intensive Care Unit stay (h) | length of Intensive Care Unit stay measured in hours | on average 48 hours after surgery | 
| hospital stay (days) | length of hospital stay after surgery | after surgery until hospital discharge (on average until 7th day after surgery) | 
| treatment cost (USD) | total treatment cost measured in both experimental and control group from hospital admission to hospital discharge | from patient hospital admission to hospital discharge ( on average 8-10 days) |