Arteriovenous Fistula ThrombosisNCT05960877
The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula
An observational study of Arteriovenous Fistula Thrombosis, run by Assiut University.
Trial summary
study the risk factors of thrombosis in thrombosed arteriovenous fistula in patients on regular hemodialysis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arteriovenous Fistula Thrombosis
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .
Who may be able to join
- All patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .
Who cannot join
- Patients with known other risk factors of thrombosis, e.g., malignancy, pregnancy, cocs and nephrotic syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula in Patients on Regular Hemodialysis
study the risk factors of thrombosis in thrombosed arteriovenous fistula in patients on regular hemodialysis
Read the 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 .
- Conditions
- Arteriovenous Fistula Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week following AV Fistula occlusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Fistula ThrombosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Aldosouky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960877
- Sponsor's protocol ID
- AV fistula thrombosis
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36116428Goldwasser 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.
PubMed 7977320Fila 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.
PubMed 32869172Fekih-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.
PubMed 27004938Vascular 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.
PubMed 16813989Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.
PubMed 8724885Salahi 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.
PubMed 16797276
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk Factors of Thrombosis in Complicated Arteriovenous Fistula in Patients on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT05960877
- Acronym / sponsor ID
- AV fistula thrombosis
- Conditions
- Arteriovenous Fistula Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
study the risk factors of thrombosis in thrombosed arteriovenous fistula in patients on regular hemodialysis
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .
Key inclusion criteria (1 listed)
- All patients on maintenance hemodialysis treatment at the dialysis unit of the department of nephrology in Assiut University Hospital .
Key exclusion criteria (1 listed)
- Patients with known other risk factors of thrombosis, e.g., malignancy, pregnancy, cocs and nephrotic syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 36116428Zhang 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.
- Background: PubMed 7977320Goldwasser 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.
- Background: PubMed 32869172Fila 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.
- Background: PubMed 27004938Fekih-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.
- Background: PubMed 16813989Vascular 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.
- Background: PubMed 8724885Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.
- Background: PubMed 16797276Salahi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula Thrombosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Aldosouky, Resident (01126124827, 7madaa.aldosouky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the risk factors of thrombosis in complicated AV Fistula in patients on regular hemodialysis (time frame: 1 week following AV Fistula occlusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05960877, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.