Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
NCT ID: NCT04402775
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
25 participants
INTERVENTIONAL
2016-04-30
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relationship Between Arterial Variations and Patency of Arteriovenous Fistulae
NCT04613115
Endothelial Function and Arterio-Venous Fistula Maturation
NCT01604473
Collateral Ligation in Failing Fistulas
NCT03365089
Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
NCT04017806
The Outcomes of Arteriovenous Fistula Cannulated From Different Direction.
NCT01642459
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Remarkable are the stenoses that seem to develop in the venous outflow tract where the vascular clamp was located during surgery. The primary aim of this study was to compare bloodless surgery using vascular clamps and a tourniquet with respect to the development of hemodynamic or anatomical significant stenosis in patients with a brachiocephalic or radiocephalic AVF.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vascular clamps
Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
No interventions assigned to this group
Tourniquet
Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
Tourniquet
A tourniquet will be used during surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tourniquet
A tourniquet will be used during surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent
* Age 18 years and older
* Indication for brachiocephalic AVF in HagaZiekenhuis
* Patient is able to complete the follow-up evaluation
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
HagaZiekenhuis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
M.J.C. de Kok
Medical student
References
Explore related publications, articles, or registry entries linked to this study.
Biuckians A, Scott EC, Meier GH, Panneton JM, Glickman MH. The natural history of autologous fistulas as first-time dialysis access in the KDOQI era. J Vasc Surg. 2008 Feb;47(2):415-21; discussion 420-1. doi: 10.1016/j.jvs.2007.10.041.
Hodges TC, Fillinger MF, Zwolak RM, Walsh DB, Bech F, Cronenwett JL. Longitudinal comparison of dialysis access methods: risk factors for failure. J Vasc Surg. 1997 Dec;26(6):1009-19. doi: 10.1016/s0741-5214(97)70014-4.
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.
Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.
Turmel-Rodrigues L, Mouton A, Birmele B, Billaux L, Ammar N, Grezard O, Hauss S, Pengloan J. Salvage of immature forearm fistulas for haemodialysis by interventional radiology. Nephrol Dial Transplant. 2001 Dec;16(12):2365-71. doi: 10.1093/ndt/16.12.2365.
Duijm LE, Overbosch EH, Liem YS, Planken RN, Tordoir JH, Cuypers PW, Douwes-Draaijer P, de Haan MW. Retrograde catheterization of haemodialysis fistulae and grafts: angiographic depiction of the entire vascular access tree and stenosis treatment. Nephrol Dial Transplant. 2009 Feb;24(2):539-47. doi: 10.1093/ndt/gfn526. Epub 2008 Sep 18.
Beathard GA, Arnold P, Jackson J, Litchfield T; Physician Operators Forum of RMS Lifeline. Aggressive treatment of early fistula failure. Kidney Int. 2003 Oct;64(4):1487-94. doi: 10.1046/j.1523-1755.2003.00210.x.
Turmel-Rodrigues L, Boutin JM, Camiade C, Brillet G, Fodil-Cherif M, Mouton A. Percutaneous dilation of the radial artery in nonmaturing autogenous radial-cephalic fistulas for haemodialysis. Nephrol Dial Transplant. 2009 Dec;24(12):3782-8. doi: 10.1093/ndt/gfp324. Epub 2009 Jul 1.
Grogan J, Castilla M, Lozanski L, Griffin A, Loth F, Bassiouny H. Frequency of critical stenosis in primary arteriovenous fistulae before hemodialysis access: should duplex ultrasound surveillance be the standard of care? J Vasc Surg. 2005 Jun;41(6):1000-6. doi: 10.1016/j.jvs.2005.02.019.
Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL54827.098.15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.