Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis (FAV-2019)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: AV Fistula

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06815159

FAV-2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

First FAV

Experimental group

Description:

Group of patient with first FAV

Treatment:

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

Secondary FAV

Experimental group

Description:

Group of patients with reintervention of FAV

Treatment:

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