The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula

Arteriovenous Fistula Thrombosis Clinical Trial

Official title:

The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula in Patients on Regular Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960877
• Other study ID #: AV fistula thrombosis
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Mohamed Aldosouky, Resident
• Phone: 01126124827
• Email: 7madaa.aldosouky[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The number of patients being treated for kidney failure continues to increase every year at a significantly higher rate than that of the world population.

The main renal replacement therapy was hemodialysis (HD) in 57% patients and peritoneal dialysis in 5% patients, while 37% patients underwent a functional kidney transplant.

Native arteriovenous fistula (AVF) is currently the best VA when technically feasible, according to the international dialysis guidelines.

Hemodialysis vascular access failure is the dominant cause of morbidity and the major cost of care for end-stage renal disease (ESRD) patients .

Complications such as thrombosis of VA remain the main problem for many patients with kidney failure.

Since 1994, prospective and case-control studies have explored the relationship between risk factors and arteriovenous fistula thrombus (AVFT) in patients undergoing HD .

Until now, these studies and reviews have revealed that numerous risk factors are associated with AVFT .

Risk factors like arterio-venous graft, age, female sex, C-reactive protein level, fistula site (distal), hypertension and the use of eprex can be associated with AVFT, and this knowledge advances the understanding of AVFT, facilitates multivariable risk prediction profiling, and lays the foundation for future preventive strategies .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Thrombosis
• Fistula
• Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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