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

CHD - Coronary Heart Disease Clinical Trial

— Hemopatch  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340090
• Other study ID #: 022017
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Medical Universtity of Lodz
• Contact: Michal Krejca, PhD,Md
• Phone: +48422014460
• Email: michal.krejca[@]umed.lodz.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CHD - Coronary Heart Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Poland	Medical University of Lodz	Lódz	Lodzkie

Sponsors (2)

Lead Sponsor	Collaborator
Medical Universtity of Lodz	Baxter Healthcare Corporation

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative drainage (ml)	total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)	measured 48 hours after surgery
Primary	need for blood transfusion (number of blood units transfused)	the total amount of blood passed to the patient	measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
Primary	The number of reoperations	The necessity of performing retoractomy due to excessive drainage or cardiac tamponade	observed until 7 days after surgery
Secondary	level of hemoglobin (g/dl)	level of hemoglobin tested in perioperative time frame	after surgery until hospital discharge (on avarage until 7th day after surgery)
Secondary	length of Intensive Care Unit stay (h)	length of Intensive Care Unit stay measured in hours	on average 48 hours after surgery
Secondary	hospital stay (days)	length of hospital stay after surgery	after surgery until hospital discharge (on average until 7th day after surgery)
Secondary	treatment cost (USD)	total treatment cost measured in both experimental and control group from hospital admission to hospital discharge	from patient hospital admission to hospital discharge ( on average 8-10 days)