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

NCT03405233 | Unknown

• 1 other identifier: R.18.01.6.R1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

End Stage Renal Disease

Keywords

ESRD; ePTFE; neointemal hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• secondary patency

  2 years after restoration of patency

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

Single vein cuffed PTFE graft at the outflow end

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

Group C

ACTIVE COMPARATOR

PTFE graft without vein cuff will be used

Procedure: ePTFE graft without any cuff

Interventions

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

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

ePTFE graft without any cuff PROCEDURE

anastmosis between arterial and venous side usinf non cuffed ePTFE graft

Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of medicine

Al Mansurah, Delta, 35516, Egypt

RECRUITING

Related Publications (4)

• Cheng C, Tempel D, van Haperen R, van der Baan A, Grosveld F, Daemen MJ, Krams R, de Crom R. Atherosclerotic lesion size and vulnerability are determined by patterns of fluid shear stress. Circulation. 2006 Jun 13;113(23):2744-53. doi: 10.1161/CIRCULATIONAHA.105.590018. Epub 2006 Jun 5.

  PMID: 16754802 BACKGROUND

• Ghonemy TA, Farag SE, Soliman SA, El-okely A, El-hendy Y. Epidemiology and risk factors of chronic kidney disease in the El-Sharkia Governorate, Egypt. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):111-7. doi: 10.4103/1319-2442.174137.

  PMID: 26787576 BACKGROUND

• Ong S, Barker-Finkel J, Allon M. Long-term outcomes of arteriovenous thigh grafts in hemodialysis patients: a comparison with tunneled dialysis catheters. Clin J Am Soc Nephrol. 2013 May;8(5):804-9. doi: 10.2215/CJN.09240912. Epub 2013 Jan 31.

  PMID: 23371958 BACKGROUND

• Tsoulfas G, Hertl M, Ko DS, Elias N, Delmonico FL, Romano L, Fernandes I, Schoenfeld D, Kawai T. Long-term outcome of a cuffed expanded PTFE graft for hemodialysis vascular access. World J Surg. 2008 Aug;32(8):1827-31. doi: 10.1007/s00268-008-9514-z.

  PMID: 18343971 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hussein mohamed Abdelaziz, PHD

CONTACT

+201002421140; menhag@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the patients do not know which group will they belong the duplex operator will not know the details of operative data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of vascular surgery

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: February 1, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)