Vascular Graft Storage Solution Preserves Endothelial Function

Vein Injury Clinical Trial

— VGE  

Official title:

Vascular Graft Storage Solution Preserves Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04614077
• Other study ID #: A2020
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Klinikum Floridsdorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vein Injury

Intervention

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

Locations

Country	Name	City	State
Austria	KH North Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Floridsdorf

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Santoli E, Di Mattia D, Boldorini R, Mingoli A, Tosoni A, Santoli C. University of Wisconsin solution and human saphenous vein graft preservation: preliminary anatomic report. Eur J Cardiothorac Surg. 1993;7(10):548-52. — View Citation

Winkler B, Reineke D, Heinisch PP, Schönhoff F, Huber C, Kadner A, Englberger L, Carrel T. Graft preservation solutions in cardiovascular surgery. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):300-9. doi: 10.1093/icvts/ivw056. Epub 2016 Apr 10. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vessel function organ bath assessment	defines significant contraction or relaxation between the two solutions, a myograph will be used, every change above 5 nM will be seen as significant.	3 hours
Secondary	cell viability testing	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	60 minutes