An interventional study of Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. in AV Fistula, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Prevention
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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.
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.
248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 150 is above the median of 64 across 166 interventional studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group of patient with first FAV
Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.
Group of patients with reintervention of FAV
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 influence its duration.
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.
Biomarkers of the treated fistula are histologically examined
Time frame: From the first patient entrolled, up to the 150th patient, an average of 6 years
Different expression of tissue markers before and during dialysis.
Markers expression of the treated tissue are analysed and compared between the two study group.
Time frame: From the first patient enrolled to the 150th patient, an average of 6 years
Markers differences between Basilic and cephalic vein
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.
Time frame: From the first patient enrolled, up to the 150th patient, up to 6 years
Started Mar 2020 (actual). Primary completion is estimated for Dec 2025, 69 months after the start.
Of 58 non-industry interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 43. This study's planned 69 months is above that.
Counting every sponsor, half of 84 studies reached it within 22 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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