Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis. (ABAS)
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|ClinicalTrials.gov Identifier: NCT04402775|
Recruitment Status : Terminated (Due to a low inclusion rate)
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula Tourniquet Stenosis||Other: Tourniquet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients eligible for the trial were randomly allocated to the tourniquet group (intervention) or vascular clamp group (control)|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Brachiocephalic Arteriovenous Fistulae: Two Different Techniques of Bloodless Surgery and Their Effect on Fistula Stenosis.|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
No Intervention: Vascular clamps
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.
A tourniquet will be used during surgery
- Stenosis postoperative (duplex ultrasonography) [ Time Frame: 6 weeks ]Luminal vessel diameter
- Duration of surgery [ Time Frame: During surgery ]Duration of surgery in minutes
- AVF occlusion [ Time Frame: Within 3 months after surgery ]AVF occlusion
- Bleeding [ Time Frame: Within 3 months after surgery ]Bleeding
- Infection [ Time Frame: Within 3 months after surgery ]Infection
- Pseudoaneurysm [ Time Frame: Within 3 months after surgery ]Pseudoaneurysm
- Need for reintervention [ Time Frame: 1 year postoperative ]Surgical or endovascular reintervention