Vascular Graft Storage Solution Preserves Endothelial Function

NCT ID: NCT04614077

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-09-30

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.

Conditions

Vein Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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

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.

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

organ bath ex vivo comparing saline vs specific solution

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinikum Floridsdorf

OTHER

Sponsor Role: lead

Responsible Party

Bernhard Winkler, Associate Professor Priv. Doz. DDR.

Associate Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard Winkler, Associate Professor Priv. Doz. DDR.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Floridsdorf

Locations

KH North Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 8267997 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27068248 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39076175 (View on PubMed)

Other Identifiers

A2020

Identifier Type: -

Identifier Source: org_study_id