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

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.

Study Overview

• Status: Unknown
• Conditions: CHD - Coronary Heart Disease
• Intervention / Treatment: Device: Medical Device Hemopatch-PEG-coated collagen patch

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lodzkie
    • Łódź, Lodzkie, Poland
      • Recruiting
      • Medical University of Lodz
      • Contact: Michal Krejca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
No Intervention: Control; Second group of patients will undergo standard CABG procedure in CPB only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative drainage (ml)	total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)	measured 48 hours after surgery
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)
The number of reoperations	The necessity of performing retoractomy due to excessive drainage or cardiac tamponade	observed until 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
length of Intensive Care Unit stay (h)	length of Intensive Care Unit stay measured in hours	on average 48 hours after surgery
hospital stay (days)	length of hospital stay after surgery	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	from patient hospital admission to hospital discharge ( on average 8-10 days)

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Michal Krejca, PhD, Md, Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 022017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes