"Effect of Perioperative and Short-Term Apixaban Therapy on Arteriovenous Fistula Maturation in Patients With End-Stage Renal Disease: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- AV Fistula Maturation
研究概览
简要总结
End-stage renal disease (ESRD) is a growing global health burden, and the creation of a native arteriovenous fistula (AVF) is the gold standard for vascular access in patients requiring hemodialysis [1]. AVFs offer superior longevity, fewer infectious complications, and lower mortality rates compared to central venous catheters or synthetic grafts [2]. However, a significant limitation to their widespread success is the high rate of early failure, primarily due to failure to mature (FTM). FTM occurs in 20-40% of AVFs, rendering them unusable for dialysis [3].
Apixaban, a direct factor Xa inhibitor, offers a potential advantage by providing sustained anticoagulation throughout the critical maturation period [7]. Its predictable pharmacokinetics, oral administration, and favorable safety profile make it an attractive agent for short-term use in this setting [8]. By reducing microthrombotic events during the first 4-6 weeks following AVF creation, apixaban could potentially improve maturation rates. However, this potential benefit must be weighed against the increased risk of bleeding, hematoma formation, and wound complications that could negatively impact fistula maturation [9].
详细描述
End-stage renal disease (ESRD) is a growing global health burden, and the creation of a native arteriovenous fistula (AVF) is the gold standard for vascular access in patients requiring hemodialysis [1]. AVFs offer superior longevity, fewer infectious complications, and lower mortality rates compared to central venous catheters or synthetic grafts [2]. However, a significant limitation to their widespread success is the high rate of early failure, primarily due to failure to mature (FTM). FTM occurs in 20-40% of AVFs, rendering them unusable for dialysis [3].
The maturation process is a complex physiological response to the newly created arteriovenous anastomosis, requiring adequate arterial inflow, venous outflow, and vessel remodeling [4]. Thrombosis during this critical maturation period remains a major cause of early AVF failure [5]. While systemic intraoperative heparin (as discussed in the referenced review) provides transient anticoagulation during the immediate perioperative period, it has a half-life of only 1-2 hours and does not provide prolonged protection during the weeks following surgery when maturation is occurring [6].
To date, no randomized controlled trial has specifically evaluated the role of short-term, protocol-directed apixaban therapy initiated at the time of AVF creation and continued through the maturation period. This study aims to determine whether perioperative and short-term apixaban therapy improves AVF maturation rates without significantly increasing bleeding complications.
2. Research Question (PICO) Population: Adult patients (≥18 years) with ESRD undergoing primary upper extremity AVF creation (radiocephalic, brachiocephalic, or brachiobasilic).
Intervention: Short-term therapeutic apixaban initiated immediately postoperatively and continued for 6 weeks during the maturation period.
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
- •Age ≥ 18 years.
- •Diagnosis of ESRD (eGFR < 15 mL/min/1.73m² or already on dialysis) with plans for hemodialysis.
- •Planned primary upper extremity AVF creation (radiocephalic, brachiocephalic, or brachiobasilic).
- •Suitable vessels on preoperative duplex ultrasound (artery ≥ 2 mm, vein ≥ 2.5 mm without tourniquet).
- •Ability to provide informed consent.
排除标准
- •Known bleeding diathesis or hypercoagulable state.
- •Current therapeutic anticoagulation (any indication).
- •Current dual antiplatelet therapy.
- •History of intracranial hemorrhage.
- •Known allergy or hypersensitivity to apixaban.
- •Inability to comply with study protocol or follow-up.
研究组 & 干预措施
Apiban group
Apiban 2.5mg BD
干预措施: Apixaban (Drug)
Non-Apiban group
No Apiban given
结局指标
主要结局
AV Fistula Maturation
时间窗: Six weeks from index operation
As per standard definitions
次要结局
未报告次要终点
