Vascular Graft Storage Solution Preserves Endothelial Function

NCT04614077 | Completed

• 1 other identifier: A2020
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vein Injury

Keywords

vein; preservation; endothelium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cell viability testing

  60 minutes

Study Arms (2)

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

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

Interventions

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

Also known as: organ bath ex vivo comparing saline vs specific solution

A( saline); B specific solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing bypass surgery exluding emergency cases

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Klinikum Floridsdorf: lead

Study Sites (1)

KH North Vienna

Vienna, 1230, Austria

Location

Related Publications (3)

• 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.

  PMID: 8267997 BACKGROUND

• 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.

  PMID: 27068248 BACKGROUND

• Kiss A, Szabo PL, Dostal C, Arnold Z, Geisler D, Crailsheim I, Folkmann S, Grabenwoger M, Podesser BK, Winkler B. Specific Graft Treatment Solution Enhances Vascular Endothelial Function. Rev Cardiovasc Med. 2022 Oct 28;23(11):368. doi: 10.31083/j.rcm2311368. eCollection 2022 Nov.

  PMID: 39076175 DERIVED

Study Officials

• Bernhard Winkler, Associate Professor Priv. Doz. DDR.

  Klinikum Floridsdorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: November 3, 2020
• Study Start: January 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)