An interventional study of Medical Device Hemopatch-PEG-coated collagen patch in CHD - Coronary Heart Disease, sponsored by Medical University of Lodz. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Second group of patients will undergo standard CABG procedure in CPB only.
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.
Total 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)
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Medical University of Lodz