A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Primary Unassisted Patency
研究概览
简要总结
Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
详细描述
Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
- •Adult (age ≥ 18 years old);
- •Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
- •Estimated life expectancy > 1 year;
- •Written informed consent obtained;
- •Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation
排除标准
- •Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
- •New York Heart Association class III or IV heart failure;
- •Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
- •Known central venous stenosis, central vein narrowing > 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
- •Prior arm surgically created access in the planned treatment arm;
- •Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).
研究组 & 干预措施
mNT-BBAVF
These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess.
干预措施: mNT-BBAVF (Procedure)
RCAVF
These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess.
干预措施: RCAVF (Procedure)
结局指标
主要结局
Primary Unassisted Patency
时间窗: 1 year
This is the time of access creation or placement until any first intervention to maintain or restore blood flow
次要结局
- Early Dialysis Suitability Failure(3 months)
- Cumulative Patency(1 year)
- Immediate Vascular Access Failure(72 hours)
研究者
Ai Peng
MD, PhD
Shanghai 10th People's Hospital