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NCT Number: NCT06815159

Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis

The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.

POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Mauro Prof Gargiulo, MD

CONTACT

[email protected]

0512143288

About this study

The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.

Patients will be treated according to clinical practice in accordance with the physician's judgment.

The study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years;
  • Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
  • Obtaining informed consent signed by the patient

Exclusion criteria

Treatment and study plan

Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.

Biological

Primary objective

  • Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.

Secondary objectives

  • Compare the results on the possible different expression of tissue markers before and during dialysis.
  • Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.

Primary outcomes

  1. Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.

    Time frame: From the first patient entrolled, up to the 150th patient, an average of 6 years

    Biomarkers of the treated fistula are histologically examined

Secondary outcomes

  1. Different expression of tissue markers before and during dialysis.

    Time frame: From the first patient enrolled to the 150th patient, an average of 6 years

    Markers expression of the treated tissue are analysed and compared between the two study group.

  2. Markers differences between Basilic and cephalic vein

    Time frame: From the first patient enrolled, up to the 150th patient, up to 6 years

    Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.

Study contacts

Contact information is provided by the study sponsor or research team.

Mauro Gargiulo, MD

CONTACT

[email protected]

0512143288

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: FAV-2019

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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