NCT05832476

Brief Summary

We divided into three parts to carry out. Firstly, evidence the pre-existing fibrosis in vein of AVF failure patients. investigation of expression, the role, and the mechanism by which the identified O-GlcNAac proteins promote, maturation of AV fistula. Finally, ddress and compare the proteomics differentiation between failure and maturation of AVF patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

April 14, 2023

Last Update Submit

April 16, 2023

Conditions

Keywords

Arteriovenous Fistulavascular smooth musclehistological techniqueO-GlcNacproteomics

Outcome Measures

Primary Outcomes (1)

  • The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months

    Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).

    Postoperative Three months

Study Arms (2)

Matured

It is defined as the target HDAVF can be used

Other: No intervention

Non-matured

RC-AVF underwent additional intervention after 90 days of observation

Other: No intervention

Interventions

No intervention

MaturedNon-matured

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible for the creation of a native HDAVF that include:the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm.

You may qualify if:

  • Age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible for the creation of a native HDAVF that include:the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm.

You may not qualify if:

  • The patient refused to join the study
  • Too weak
  • Serious heart failure
  • Unconsciousness
  • Bedridden for long time
  • systemic lupus erythematosus(SLE), or other known autoimmune diseases
  • The physician excludes the possibility of creating a wrist HDAVF before surgery
  • Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF
  • Choose a site other than the wrist for surgery
  • Unexpected negative complications happen during surgery that prevent the completion of a wirst HDAVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, No.7, Chung Shan S. Rd, 10002, Taiwan

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Chih-Yang Chan, phd

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 27, 2023

Study Start

March 28, 2018

Primary Completion

October 26, 2020

Study Completion

October 26, 2020

Last Updated

April 27, 2023

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations