Vascular Graft Storage Solution Preserves Endothelial Function (VGE)

Klinikum Floridsdorf

Status: Completed

Conditions: Vein Injury

Treatments: Other: ex vivo organ bath testing, preservation of vein sections without contact to patient

Study type: Observational

Funder types: Other

Identifiers

NCT04614077

A2020

Details and patient eligibility

About

Since Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function the main aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments 8 Remnants from the operation after trimming the bypass length), rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline.

Full description

Saline is still the most widely used storage and flushing solution in cardiovascular procedures despite knowing evidence of its influence on the human endothelial cell function. Aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment solution, on human saphenous vein segments, rat aortic segments and human umbilical vein endothelial cells (HUVECs) in comparison to saline. According to literature saline could have detrimental effects on the endothelium but data shows conflicting evidence. Duragraft a so called endothelial preservation solution should protect the human endothelium. Intent of this observational study was to study the effects of both solutions and compare them.

Within 12 patients undergoing aortocoronary bypass surgery, left overs from saphenous vein graft segments were randomized to DuraGraft© (n=12/6) or saline (n=12/6) solution before intraoperative storage. These segments as well as rat aortic segments underwent assessment of vascular function in a multichamber isometric myograph system in comparison to Krebs-Henseleit solution (KHS), a physiologic organ buffer solution. Additionally, human umbilical vein endothelial cells (HUVECs) were used for cell viability tests.

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
• Patient is ≥18 years of age
• Patient (or a legally authorized representative) is willing and able to provide consent
• DuraGraft® is being used for the CABG procedure

Exclusion criteria

• Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.

Trial design

12 participants in 2 patient groups

A( saline)

Description:

The vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution.

Treatment:

Other: ex vivo organ bath testing, preservation of vein sections without contact to patient

B specific solution

Description:

The vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution.

Treatment:

Other: ex vivo organ bath testing, preservation of vein sections without contact to patient