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Criteria for Accessory Vein Obliteration Trial.

NCT02632942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-10-04

No results posted yet for this study

Summary

Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in significant morbidity amongst patients with End Stage Renal Disease (ESRD), causing a severe economic burden on any health care system. Native arteriovenous fistula (AVF) is the preferred form of permanent dialysis access since it is associated with the best long term outcome as compared to other forms of dialysis access. Despite the clinical benefits, many patients on HD do not have AVF as there dialysis access. One of the reasons for low AVF rates is early fistula failure (EFF). The two most important causes for EFF amenable to intervention are stenosis anywhere in the circuit and/or presence of accessory vein (av). Although management of stenosis is well established with relatively clear guidelines, the management of av lacks clear scientific approach. In a recent study researchers recommended a hemodialysis arteriovenous flow quantification-diameter (HAQ) criteria for accessory vein obliteration. The purpose of this controlled, blinded, prospective trial is to assess the clinical utility of the HAQ criteria as compared to current recommendations for av obliteration.

Conditions

  • Arteriovenous Fistula Maturation Failure

Interventions

PROCEDURE

HAQ criteria

Obliteration of accessory vein which satisfy the HAQ criteria as below: 1. 60% or greater diameter of the main AVF 2. 50% diameter of AVF with at least one more av\>40% in diameter. 3. 50% in diameter and divides into branches of same size. 4. av likely to interfere with cannulation on physical examination. 5. \>30% in diameter and associated with stenosis at site of origin.

PROCEDURE

Current Recommendation

Obliteration of accessory vein which satisfy current recommendations defined as the diameter greater than 25% of the AVF diameter.

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Naveed Haq, MD, FASN · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632942 on ClinicalTrials.gov