Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis (FAV-2019)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mauro Gargiulo, MD
- Phone Number: 0512143288
- Email: mauro.gargiulo2@unibo.it
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- IRCCS AOU di Bologna Policlinico di Sant'Orsola
-
Contact:
- Mauro Prof Gargiulo, MD
- Phone Number: 0512143288
- Email: mauro.gargiulo2@unibo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: First FAV
Group of patient with first FAV
|
Primary objective
|
|
Experimental: Secondary FAV
Group of patients with reintervention of FAV
|
Primary objective
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From the first patient entrolled, up to the 150th patient, an average of 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
|
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.
|
From the first patient enrolled, up to the 150th patient, up to 6 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mauro Gargiulo, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAV-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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