NCT05960877

Brief Summary

study the risk factors of thrombosis in thrombosed arteriovenous fistula in patients on regular hemodialysis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

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

First Submitted

Initial submission to the registry

July 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 13, 2023

Last Update Submit

July 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of the risk factors of thrombosis in complicated AV Fistula in patients on regular hemodialysis

    Provide the evidence on the association between potential risk factors and arteriovenous fistula thrombus

    1 week following AV Fistula occlusion

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .

You may qualify if:

  • All patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .

You may not qualify if:

  • Patients with known other risk factors of thrombosis, e.g., malignancy, pregnancy, cocs and nephrotic syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Zhang Y, Yi J, Zhang R, Peng Y, Dong J, Sha L. Risk Factors for Arteriovenous Fistula Thrombus Development: A Systematic Review and Meta-Analysis. Kidney Blood Press Res. 2022;47(11):643-653. doi: 10.1159/000526768. Epub 2022 Sep 16.

    PMID: 36116428BACKGROUND
  • Goldwasser P, Avram MM, Collier JT, Michel MA, Gusik SA, Mittman N. Correlates of vascular access occlusion in hemodialysis. Am J Kidney Dis. 1994 Nov;24(5):785-94. doi: 10.1016/s0272-6386(12)80672-x.

    PMID: 7977320BACKGROUND
  • Fila B. Quality indicators of vascular access procedures for hemodialysis. Int Urol Nephrol. 2021 Mar;53(3):497-504. doi: 10.1007/s11255-020-02609-5. Epub 2020 Aug 31.

    PMID: 32869172BACKGROUND
  • Fekih-Mrissa N, Sayeh A, Baffoun A, Beji M, Mrad M, Hmida J, Nsiri B. Association Between Thrombophilic Gene Mutations and the Risk of Vascular Access Thrombosis in Hemodialysis Patients. Ther Apher Dial. 2016 Apr;20(2):107-11. doi: 10.1111/1744-9987.12379. Epub 2016 Mar 23.

    PMID: 27004938BACKGROUND
  • Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available.

    PMID: 16813989BACKGROUND
  • Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.

    PMID: 8724885BACKGROUND
  • Salahi H, Fazelzadeh A, Mehdizadeh A, Razmkon A, Malek-Hosseini SA. Complications of arteriovenous fistula in dialysis patients. Transplant Proc. 2006 Jun;38(5):1261-4. doi: 10.1016/j.transproceed.2006.02.066.

    PMID: 16797276BACKGROUND

Central Study Contacts

Mohamed Aldosouky, Resident

CONTACT

Wael Hassanain, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 27, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

July 27, 2023

Record last verified: 2023-07