NCT03340090

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CHD - Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Medical 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.

Timeline

• Start date: 2018-03-20
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-11-13
• Last updated: 2019-08-09

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated device study