Clinical trial NCT04614077: Vascular Graft Storage Solution Preserves Endothelial Function
Official title: Vascular Graft Storage Solution Preserves Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vein Injury
Keywords: vein
preservation
endothelium
Lead sponsor: Klinikum Floridsdorf
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing bypass surgery exluding emergency cases

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: vessel function organ bath assessment
timeFrame: 3 hours
Secondary outcomes:
measure: cell viability testing
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: KH North Vienna
Study officials:
affiliation: Klinikum Floridsdorf
name: Bernhard Winkler, Associate Professor Priv. Doz. DDR.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/1010-7940(93)90055-g.
citation: Winkler B, Reineke D, Heinisch PP, Schonhoff 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.