Vein InjuryVGENCT04614077
Vascular Graft Storage Solution Preserves Endothelial Function
An observational study of Vein Injury, run by Klinikum Floridsdorf at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vein Injury
- What is being tested?
- ex vivo organ bath testing, preservation of vein sections without contact to patient
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing bypass surgery exluding emergency cases
Who may be able to join
- 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
Who cannot join
- Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- ex vivo organ bath testing, preservation of vein sections without contact to patient
- Keywords
- vein, preservation, endothelium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex vivo organ bath testing, preservation of vein sections without contact to patientOther
Also called organ bath ex vivo comparing saline vs specific solution
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ex vivo organ bath testing, preservation of vein sections without contact to patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Secondary outcomes (1)
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
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jan 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vein InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Floridsdorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Winkler, Associate Professor Priv. Doz. DDR., Klinikum Floridsdorf
- Investigators
- Bernhard Winkler, Associate Professor Priv. Doz. DDR., Principal investigator, Klinikum Floridsdorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614077
- Sponsor's protocol ID
- A2020
- Acronym
- VGE
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only during publication or manuscript preparation data will be shared but no patients names or data.
Publications
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.
PubMed 8267997Winkler 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.
PubMed 27068248Kiss 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.
PubMed 39076175
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Graft Storage Solution Preserves Endothelial Function
- ClinicalTrials.gov ID
- NCT04614077
- Acronym / sponsor ID
- VGE / A2020
- Conditions
- Vein Injury
- Keywords
- vein, preservation, endothelium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Klinikum FloridsdorfUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A( saline) | – | Other: ex vivo organ bath testing, preservation of vein sections without contact to patientThe vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution. |
| B specific solution | – | Other: ex vivo organ bath testing, preservation of vein sections without contact to patientThe vein piece 1 cm is taken from one patient, then the piece is divided and assigned to saline or the specific solution. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing bypass surgery exluding emergency cases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in a device study or receiving active drug product in an investigational study within one month (30 days) prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex vivo organ bath testing, preservation of vein sections without contact to patientAlso: organ bath ex vivo comparing saline vs specific solution1 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 | A( saline), B specific solution |
Primary outcome
vessel function organ bath assessment
Time frame: 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.
1 secondary outcome
cell viability testing
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 8267997Santoli 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.
- Background: PubMed 27068248Winkler 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.
- Derived from this study: PubMed 39076175Kiss 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.
- Individual participant dataSharing planned: No. only during publication or manuscript preparation data will be shared but no patients names or data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard Winkler, Associate Professor Priv. Doz. DDR. principal investigator
Klinikum Floridsdorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vein Injury, run by Klinikum Floridsdorf at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vessel function organ bath assessment (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614077, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.