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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
RECRUITINGTotal postoperative drainage (ml)
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
Time frame: measured 48 hours after surgery
need for blood transfusion (number of blood units transfused)
the total amount of blood passed to the patient
Time frame: 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
Time frame: observed until 7 days after surgery
level of hemoglobin (g/dl)
level of hemoglobin tested in perioperative time frame
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
Time frame: on average 48 hours after surgery
hospital stay (days)
length of hospital stay after surgery
Time frame: 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
Time frame: from patient hospital admission to hospital discharge ( on average 8-10 days)
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