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

Not Applicable

Recruiting

• Conditions: AV Fistula
• Interventions: Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.

• Registration Number: NCT06815159
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2020-03-18
• Status Verified: 2024-11
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First FAV	Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.	Group of patient with first FAV
Secondary FAV	Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.	Group of patients with reintervention of FAV

Primary Outcome Measures

Name	Time	Method
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.	From the first patient entrolled, up to the 150th patient, an average of 6 years	Biomarkers of the treated fistula are histologically examined

Secondary Outcome Measures

Name	Time	Method
Different expression of tissue markers before and during dialysis.	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.
Markers differences between Basilic and cephalic vein	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.

Trial Locations

Locations (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy