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

NCT ID: NCT06815159

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed 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.

Conditions

AV Fistula

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

First FAV

Group of patient with first FAV

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Primary objective

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

Secondary objectives

2. Compare the results on the possible different expression of tissue markers before and during dialysis.

3. 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.

Secondary FAV

Group of patients with reintervention of FAV

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Primary objective

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

Secondary objectives

2. Compare the results on the possible different expression of tissue markers before and during dialysis.

3. 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.

Interventions

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

Primary objective

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

Secondary objectives

2. Compare the results on the possible different expression of tissue markers before and during dialysis.

3. 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.

Intervention Type: BIOLOGICAL

Eligibility 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

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

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauro Gargiulo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mauro Gargiulo, MD

Role: CONTACT

mauro.gargiulo2@unibo.it

0512143288

Facility Contacts

Mauro Prof Gargiulo, MD

Role: primary

mauro.gargiulo2@unibo.it

0512143288

Other Identifiers

FAV-2019

Identifier Type: -

Identifier Source: org_study_id