- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05960877
The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula
The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula in Patients on Regular Hemodialysis
Study Overview
Status
Conditions
Detailed 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 .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mohamed Aldosouky, Resident
- Phone Number: 01126124827
- Email: 7madaa.aldosouky@gmail.com
Study Contact Backup
- Name: Wael Hassanain, Prof
- Phone Number: 01064236064
- Email: wael.hassanain@med.au.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of the risk factors of thrombosis in complicated AV Fistula in patients on regular hemodialysis
Time Frame: 1 week following AV Fistula occlusion
|
Provide the evidence on the association between potential risk factors and arteriovenous fistula thrombus
|
1 week following AV Fistula occlusion
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV fistula thrombosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arteriovenous Fistula Thrombosis
-
Hospital General Universitario Gregorio MarañonSpanish Society of NephrologyCompletedArteriovenous Fistula Stenosis | Arteriovenous Fistula ThrombosisSpain
-
Singapore General HospitalNational Medical Research Council (NMRC), SingaporeRecruitingBlood Vessel Prosthesis | Arteriovenous Shunt ThrombosisSingapore
-
Renal Research InstituteCompletedFistula | Chronic Kidney Disease | Hemodialysis Fistula ThrombosisUnited States
-
Medtronic EndovascularCompletedFistula | Arteriovenous Fistula | Arteriovenous Fistula Stenosis | Arteriovenous Fistula OcclusionNew Zealand, United States, Japan
-
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Not yet recruiting
-
Cardionovum GmbHNot yet recruitingArterio-venous Fistula | Stenosis of Arteriovenous Dialysis FistulaItaly
-
Laminate Medical TechnologiesCompletedKidney Diseases | Kidney Failure, Chronic | ESRD | Renal Failure Chronic | Arterio-Venous Fistula | Arteriovenous Fistula ThrombosisUnited Kingdom, Spain, Germany, France
-
Ai PengRecruitingArteriovenous Fistula Flow Monitoring | Early Detection of Complications of Arteriovenous Fistula | VoiceprintChina
-
Assiut UniversityNot yet recruitingArteriovenous Fistula Patency