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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | No Intervention | Second group of patients will undergo standard CABG procedure in CPB only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device Hemopatch-PEG-coated collagen patch | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michał Krejca, PhD,Md | Contact | +48422014460 | michal.krejca@umed.lodz.pl | |
| Tomasz Skowronski, Md | Contact | +48422014467 | tomek.skowronski@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michal Krejca, PhD, Md | Medical University of Lodz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Lodz | Recruiting | Lodz | Łódź Voivodeship | Poland |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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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) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |