NCT03645720

Brief Summary

The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 21, 2018

Last Update Submit

August 1, 2022

Conditions

End Stage Renal Failure on Dialysis

Outcome Measures

Primary Outcomes (1)

  • Incidence of pseudoaneurysm

    critical puncture related complication in AVG

    Incidence of pseudoaneurysm at 6 months

Secondary Outcomes (2)

  • punctutre related complication

    Monthly for 6 months.

  • Dialysis adeqaucy

    Monthly for 6 months.

Study Arms (2)

Metal needle gruop

NO INTERVENTION

puncture using metal needle

plastic cannula

EXPERIMENTAL

puncture using plastic cannula

Device: Plastic cannula

Interventions

Plastic cannulaDEVICE

puncture using plastic cannula

plastic cannula

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving hemodialysis treatment using AVG

You may not qualify if:

  • Age under 20 years old or over 75 years old
  • Abnormal skin condition using immunosuppressants such as steroids.
  • Skin disorder
  • Metal allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14066, South Korea

Location

Study Officials

  • Sun Ryoung Choi, MD,PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 24, 2018

Study Start

October 22, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)