CHD - Coronary Heart Disease
Conditions
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.
Interventions
DEVICEMedical 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.
Sponsors
Baxter Healthcare Corporation
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative drainage (ml) | measured 48 hours after surgery | total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura) |
| need for blood transfusion (number of blood units transfused) | measeured after surgery until hospital discharge (on avarage until 7th day after surgery) | the total amount of blood passed to the patient |
| The number of reoperations | observed until 7 days after surgery | The necessity of performing retoractomy due to excessive drainage or cardiac tamponade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| level of hemoglobin (g/dl) | after surgery until hospital discharge (on avarage until 7th day after surgery) | level of hemoglobin tested in perioperative time frame |
| treatment cost (USD) | from patient hospital admission to hospital discharge ( on average 8-10 days) | total treatment cost measured in both experimental and control group from hospital admission to hospital discharge |
| length of Intensive Care Unit stay (h) | on average 48 hours after surgery | length of Intensive Care Unit stay measured in hours |
| hospital stay (days) | after surgery until hospital discharge (on average until 7th day after surgery) | length of hospital stay after surgery |
Countries
Poland
Contacts
Primary ContactMichał Krejca, PhD,Md
Backup ContactTomasz Skowronski, Md
Outcome results
None listed