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

NCT03340090 | Unknown FDA Device

• 1 other identifier: 022017
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

CHD - Coronary Heart Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• level of hemoglobin (g/dl)

  after surgery until hospital discharge (on avarage until 7th day after surgery)

• length of Intensive Care Unit stay (h)

  on average 48 hours after surgery

• hospital stay (days)

  after surgery until hospital discharge (on average until 7th day after surgery)

• treatment cost (USD)

  from patient hospital admission to hospital discharge ( on average 8-10 days)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Medical Device Hemopatch-PEG-coated collagen patch DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lodz: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Michal Krejca, PhD, Md

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał Krejca, PhD,Md

CONTACT

+48422014460; michal.krejca@umed.lodz.pl

Tomasz Skowronski, Md

CONTACT

+48422014467; tomek.skowronski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two randomized groups of 100 patients will undergo standard CABG procedure in Cardio-Pulmonary Bypass (CPB). In first group (100 patients) two pieces of Hemopatch will be applied in one patient. Second group is the control group without above described intervention.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 13, 2017
• Study Start: March 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

PL (1)