Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)

Study Overview
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Brief Summary
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this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality

Detailed Description
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End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.End-stage renal disease (ESRD) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. Haemodialysis (HD) is a lifeline therapy for patients with ESRD. A proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.ePTFE grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. The commonest cause of PTFE graft failure is intimal hyperplasia (IH) at the venous anastomoses. our study aims to evaluate the influence of double cuffed ePTFE grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy. this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality

Official Title
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Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients: a Randomized Controlled Trial

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow ends
* Procedure: single vein cuffed eTFE graft both at the inflow and outflow ends
* Procedure: ePTFE graft without any cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with end stage renal diseases and GFR less than 30 By clinical examination in ability to palpate distal or proximal upper limb veins 3. By duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. Patients with previous history of failed attempts of autogenous vein creation 5. Patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm). Exclusion Criteria: All patients with palpable suitable forearm or arm veins Patients with baseline blood pressure less than 110/70 Brachial artery of diameter less than 4 mm Patients with ligated brachial artery Patients with history of central vein stenosis Patients with immunodeficiency states
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Double vein cuff PTFE graft both at the inflow and outflow ends | Procedure: Double vein cuffed ePTFE graft both at the inflow and outflow ends<br>* Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft<br>|
| Active Comparator: Group B<br>Single vein cuffed PTFE graft at the outflow end | Procedure: single vein cuffed eTFE graft both at the inflow and outflow ends<br>* Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft<br>|
| Active Comparator: Group C<br>PTFE graft without vein cuff will be used | Procedure: ePTFE graft without any cuff<br>* anastmosis between arterial and venous side usinf non cuffed ePTFE graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary patency | comparing primary patency between the double cuffed, single cuffed and non cuffed ePTFE graft primary patency means how long will the graft be patent after the first intervention | 2 years for each patient after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary patency | comparing secondary patency between the double cuffed, single cuffed and non cuffed ePTFE graft secondary patency means how long will the graft be patent after thormobectomy to a thrombosed graft | 2 years after restoration of patency | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, ePTFE, neointemal hyperplasia