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

Overview

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.

Interventions

• Biological 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 infl

Primary outcome measures

• 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]

Secondary outcome measures (2)

• 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 differences between Basilic and cephalic vein [Time frame: From the first patient enrolled, up to the 150th patient, up to 6 years]

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

Exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Italy · 1 center

• IRCCS AOU di Bologna Policlinico di Sant'Orsola — Bologna

Identifiers

NCT: NCT06815159 · FAV-2019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗