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VGE: Vascular Graft Storage Solution Preserves Endothelial Function

Sponsor
Klinikum Floridsdorf (Other)
Overall Status
Completed
CT.gov ID
NCT04614077
Collaborator
(none)
12
Enrollment
1
Location
21
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ex vivo organ bath testing, preservation of vein sections without contact to patient

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Vascular Graft Storage Solution Preserves Endothelial Function
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

Arm Intervention/Treatment
A( saline)

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

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

    		•
    B specific solution

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. vessel function organ bath assessment [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 Outcome Measures

    1. cell viability testing [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KH North Vienna Vienna Austria 1230

    Sponsors and Collaborators

    • Klinikum Floridsdorf

    Investigators

    • Principal Investigator: Bernhard Winkler, Associate Professor Priv. Doz. DDR., Klinikum Floridsdorf

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bernhard Winkler, Associate Professor Priv. Doz. DDR., Associate Professor MD, Klinikum Floridsdorf
    ClinicalTrials.gov Identifier:
    NCT04614077
    Other Study ID Numbers:
    • A2020
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bernhard Winkler, Associate Professor Priv. Doz. DDR., Associate Professor MD, Klinikum Floridsdorf
    vein
    preservation
    endothelium

    Study Results

    No Results Posted as of Nov 3, 2020