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Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

NCT ID: NCT00737620

Last Updated: 2012-10-30

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.

Detailed Description

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Conditions

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Hemodialysis Fistula Thrombosis

Keywords

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Renal Failure, End Stage Blood Vessel Grafting Hemodialysis Surgical Arteriovenous Shunt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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propaten graft

Group Type ACTIVE_COMPARATOR

Prosthetic AV graft implantation

Intervention Type PROCEDURE

Surgical arteriovenous fistula creation with standard or propaten graft

Standard graft

Group Type ACTIVE_COMPARATOR

Prosthetic AV graft implantation

Intervention Type PROCEDURE

Surgical arteriovenous fistula creation with standard or propaten graft

Interventions

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Prosthetic AV graft implantation

Surgical arteriovenous fistula creation with standard or propaten graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial
* Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population

Exclusion Criteria

* Anticoagulation therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dr David Shemesh

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shaare Zedek Medical Center, Jerusalem

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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Shemesh D, Goldin I, Hijazi J, Zaghal I, Berelowitz D, Verstandig A, Olsha O. A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access. J Vasc Surg. 2015 Jul;62(1):115-22. doi: 10.1016/j.jvs.2015.01.056. Epub 2015 Mar 12.

Reference Type DERIVED
PMID: 25770987 (View on PubMed)

Other Identifiers

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11111

Identifier Type: -

Identifier Source: org_study_id