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

Medical University of Lodz

Status: Unknown

Conditions: CHD - Coronary Heart Disease

Treatments: Device: Medical Device Hemopatch-PEG-coated collagen patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03340090

022017

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Medical Device Hemopatch-PEG-coated collagen patch

Control

No Intervention group

Description:

Second group of patients will undergo standard CABG procedure in CPB only.