Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis. (ABAS)
Primary Purpose
Arteriovenous Fistula, Tourniquet, Stenosis
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tourniquet
Sponsored by
About this trial
This is an interventional prevention trial for Arteriovenous Fistula
Eligibility Criteria
Inclusion Criteria:
- Mentally competent
- 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:
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Vascular clamps
Tourniquet
Arm Description
Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
Outcomes
Primary Outcome Measures
Stenosis postoperative (duplex ultrasonography)
Luminal vessel diameter
Secondary Outcome Measures
Duration of surgery
Duration of surgery in minutes
AVF occlusion
AVF occlusion
Bleeding
Bleeding
Infection
Infection
Pseudoaneurysm
Pseudoaneurysm
Need for reintervention
Surgical or endovascular reintervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04402775
Brief Title
Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
Acronym
ABAS
Official Title
Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to a low inclusion rate
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HagaZiekenhuis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is recognized as the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs. 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.
Detailed Description
Patients with a chronic kidney disease who opt for hemodialysis, needs a well-functioning hemodialysis access. The autologous arteriovenous fistula (AVF) is the golden standard of dialysis access. Unfortunately a great number of the AVFs fail to mature, and therefore cannot be used for dialysis. A significant stenosis is a major cause of nonmaturing AVFs.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula, Tourniquet, Stenosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vascular clamps
Arm Type
No Intervention
Arm Description
Patients randomized to the use of vascular clamps to obtain a bloodless field during arteriovenous fistula surgery (standard protocol).
Arm Title
Tourniquet
Arm Type
Experimental
Arm Description
Patients randomized to the use of a tourniquet to obtain a bloodless field during arteriovenous fistula surgery.
Intervention Type
Other
Intervention Name(s)
Tourniquet
Intervention Description
A tourniquet will be used during surgery
Primary Outcome Measure Information:
Title
Stenosis postoperative (duplex ultrasonography)
Description
Luminal vessel diameter
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Duration of surgery
Description
Duration of surgery in minutes
Time Frame
During surgery
Title
AVF occlusion
Description
AVF occlusion
Time Frame
Within 3 months after surgery
Title
Bleeding
Description
Bleeding
Time Frame
Within 3 months after surgery
Title
Infection
Description
Infection
Time Frame
Within 3 months after surgery
Title
Pseudoaneurysm
Description
Pseudoaneurysm
Time Frame
Within 3 months after surgery
Title
Need for reintervention
Description
Surgical or endovascular reintervention
Time Frame
1 year postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mentally competent
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:
Pregnancy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18241764
Citation
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.
Results Reference
background
PubMed Identifier
9423717
Citation
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.
Results Reference
background
PubMed Identifier
16813989
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.
Results Reference
background
PubMed Identifier
16813991
Citation
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.
Results Reference
background
PubMed Identifier
11733628
Citation
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.
Results Reference
background
PubMed Identifier
18802208
Citation
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.
Results Reference
background
PubMed Identifier
12969170
Citation
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.
Results Reference
background
PubMed Identifier
19570886
Citation
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.
Results Reference
background
PubMed Identifier
15944600
Citation
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.
Results Reference
background
Citation
Richtlijn Shuntchirurgie, Nederlandse Vereniging voor Heelkunde. Utrecht; 2010.
Results Reference
background
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Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.
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