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

Not Applicable

• Conditions: CHD - Coronary Heart Disease
• Interventions: Device: Medical Device Hemopatch-PEG-coated collagen patch

• Registration Number: NCT03340090
• Lead Sponsor: Medical University of Lodz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Study Start: 2018-03-20
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• coronary heart disease CHD (mammary harvesting)
• age>18
• informed consent

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Exclusion Criteria

• any condition that exclude patient from standard CABG procedure
• additional cardiac procedure to be conducted on subject in addition to CABG

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Medical Device Hemopatch-PEG-coated collagen patch	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Medical University of Lodz; 🇵🇱 Łódź, Lodzkie, Poland