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Completed

NCT Number: NCT04614077

Vascular Graft Storage Solution Preserves Endothelial Function

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KH North Vienna

Vienna, 1230, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

1 piece of vein is separated during surgical bypass procedure, then randomized and put ex vivo in two solutions: saline and specific solution, then tested in the organ bath

Other names: organ bath ex vivo comparing saline vs specific solution

Primary outcomes

  1. vessel function organ bath assessment

    Time frame: 3 hours

    defines significant contraction or relaxation between the two solutions, a myograph will be used, every change above 5 nM will be seen as significant.

Secondary outcomes

  1. cell viability testing

    Time frame: 60 minutes

    shows significant difference between the two solutions, cell number of living cells will be simply counted and compared between the two solutions using a standard microscope and counting chamber

Sponsors and collaborators

Lead sponsor

Klinikum Floridsdorf

Other

Registry information

Acronym: VGE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 3, 2020
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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