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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2023-01-31

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

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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

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

the patients do not know which group will they belong the duplex operator will not know the details of operative data

Study Groups

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Group A

Double vein cuff PTFE graft both at the inflow and outflow ends

Group Type EXPERIMENTAL

Double vein cuffed ePTFE graft both at the inflow and outflow ends

Intervention Type PROCEDURE

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

Group B

Single vein cuffed PTFE graft at the outflow end

Group Type ACTIVE_COMPARATOR

single vein cuffed eTFE graft both at the inflow and outflow ends

Intervention Type PROCEDURE

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

Group C

PTFE graft without vein cuff will be used

Group Type ACTIVE_COMPARATOR

ePTFE graft without any cuff

Intervention Type PROCEDURE

anastmosis between arterial and venous side usinf non cuffed ePTFE graft

Interventions

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Double vein cuffed ePTFE graft both at the inflow and outflow ends

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

Intervention Type PROCEDURE

single vein cuffed eTFE graft both at the inflow and outflow ends

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

Intervention Type PROCEDURE

ePTFE graft without any cuff

anastmosis between arterial and venous side usinf non cuffed ePTFE graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with end stage renal diseases and GFR less than 30
2. 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

1. All patients with palpable suitable forearm or arm veins
2. Patients with baseline blood pressure less than 110/70
3. Brachial artery of diameter less than 4 mm
4. Patients with ligated brachial artery
5. Patients with history of central vein stenosis
6. Patients with immunodeficiency states

Eligible Sex

ALL

Accepts Healthy Volunteers

No