An observational study in Brachiobasilic Arteriovenous Fistula, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Assiut University · Observational
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Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula.
The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The true incidence and prevalence of Central venous stenosis in the ESRD population is unknown because most studies of Central venous stenosis are limited to symptomatic patients. Central venous stenosis may remain asymptomatic because clinical symptoms and signs of Central venous stenosis often develop only after an AVF is placed in the ipsilateral extremity and the impediment to increased blood flow is unmasked. (1) Retrospective investigations of symptomatic HD patients with various accesses using duplex ultrasonography or angiography have reported Central venous stenosis prevalences of 19%-41%. (2-4) The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central [PICC] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.
Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.
our Aims are : Evaluates the efficacy and safety of creation of a Brachiobasilic fistula in hemodialysis patients with central venous stenosis Evaluate the outcomes of Superficialization of the basilic vein after percutaneous transluminal angioplasty of the central venous stenosis
248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 71 observational studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hemodialysis patients with central venous stenosis with exhausted options of dialysis access that has only basilic vein feasible for creation of the fistula
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Exclusion Criteria:
perform 2 stage brachiobasilic AVF in hemodialysis patients with central venous stenosis
Procedural success of 1st stage Brachiobasilic fistula
Palpable thrill Fistula flow rate with duplex ultrasound
Time frame: through study completion, an average of 2 year
Primary patency
It is defined as the interval between initial creation of the fistula and its failing that requires endovascular or surgical intervention.
Time frame: through study completion, an average of 2 year
Assisted primary patency
It is defined as the time interval of the fistula remaining patent (functional) with the aid of endovascular intervention.
Time frame: through study completion, an average of 2 year
complications of the fistula
Bleeding Infection Thrombosis aneurysm formation Distal limb ischemia Severe venous hypertension.
Time frame: through study completion, an average of 2 year
Fistula maturation
It is defined as flow through the fistula greater than 600 ml/minute, vein diameter more than 6 mm and the vein less than 6 mm from the skin and adequate urea clearance with dialysis.
Time frame: 4 weeks after the fistula creation and every 2 weeks up to 24 weeks
No study locations are listed for this record.
Start is estimated for Apr 2025; primary completion for Dec 2027, 32 months later.
Of 34 observational studies under Arteriovenous Fistula, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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