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Maturation rate of Brachial artery base Arteriovenous Fistula

A randomized controlled trial of Single versus Double Outflow Vein of Arteriovenous Fistula Creation Using the Brachial Artery and Cubital Superficial Veins on Maturation growth rate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190708003
Enrollment
77
Registered
2019-07-08
Start date
2019-07-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD) stage 4 ESRD CKD ESRD

Interventions

Brachial artery to cephalic vein anastomosis for created AVF (BCAVF) (Single out flow vein = cephalic vein),Brachial artery to median antebrachial vein (MABV) anastomosis for created AVF (BMABAVF) and
Experimental Procedure/Surgery,Experimental Procedure/Surgery
Single outflow vein AVF,Double outflow vein AVF

Sponsors

Faculty of Medicine, Thammasat university
Lead Sponsor
Thammasat university
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: CKD stage 4 and 5 who planning for hemodialysisvia AVF 1 Brachial artery ≥ 2 mm at cubital fossa 2 Anatomical variations of cubital superficial vein type 1 or 2 3 Cephalic vein ≥ 2.5 mm at cubital fossa with good continuity to cephalic arch and compressible 4 MABV or MCV ≥ 2.5 mm at cubital fossa with good continuity and compressible for cubital fossa 5 No evidence of Ipsilateral CVOD (Axillary vein to SVC) 6 Ipsilateral Upper extremity PAD

Exclusion criteria

Exclusion criteria: 1 Unfit for Surgery (*ASA Physical status Classification system class 4-6) 2 Bleeding tendency 3 History of bilateral AVF creation at cubital fossa area 4 Candidated for radiocephalic wrist AVF 5 Target outflow vein (Cephalic vein, MABV or MCV not patent intraoperatively)

Design outcomes

Primary

MeasureTime frame
Growth rate of Outflow Cephalic vein segment diameter at 4, 6, 8, 12, 16 weeks after end of the intervention Mean of cephalic vein diameter/time,Increasing of access flow rate (Qa) at 4, 6, 8, 12, 16 weeks after end of the intervention Mean of access flow rate/time

Secondary

MeasureTime frame
3 months proportion of AVF Maturation at 3 months after end of the intervention Matured AVF / All AVF in each AVF creation method ,AVF creation to Maturation time at 4, 6, 8, 12, 16 weeks after end of the intervention time between day of AVF creation and AVF maturation,AVF creation to first successful use time (Subgroup analysis for CKD stage 5 or ESRD) time to events time between day of AVF creation and AVF cannulation,Brachial artery flow at 4, 6, 8, 12, 16 weeks after end of the intervention Duplex ultrasound to measured flow rate of AVF,Brachial artery diameter at 4, 6, 8, 12, 16 weeks after end of the intervention Duplex ultrasound to measured diameter of brachial artery,Post-operative complication at 4, 6, 8, 12, 16 weeks after end of the intervention Clinical examination and further investigation such as duplex ultrasound as need

Countries

Thailand

Contacts

Public ContactSaritphat Orrapin

Department of Surgery, Faculty of Medicine, Thammasat University Hospital.

Sam3_orra@hotmail.com+668-918-20013

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026