A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 103
- 试验地点
- 10
- 主要终点
- Primary Graft Patency Rate
研究概览
简要总结
The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.
详细描述
Study Design: This is a prospective, multi-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing heparin-bonded (Propaten®) versus non-heparin-bonded arteriovenous grafts.
Procedure: In patients without usable native vein, prosthetic arteriovenous grafts will be implanted for hemodialysis access. Patients will be randomized intraoperatively to either conventional (Gore® Stretch) or heparin-bonded grafts (Gore® Propaten).
Course of Study: The study will accrue patients over the course of 5 years.
Enrollment: Enrollment will consist of adult patients who require hemodialysis. If the patient cannot have a native vein arteriovenous fistula, the patient is a candidate for arteriovenous graft. Patients will be screened and consented preoperatively. If the intraoperative decision is made that the patient will require a graft, randomization will occur and the patient will be considered enrolled.
Recruitment: The target population comprises of all adult patients aged 18 years and above with end stage renal disease requiring arteriovenous access for hemodialysis. The target for enrollment will be 200 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
- Double (Participant, Outcomes Assessor)
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
- •Aged ≥18 years of all ethnicities
- •End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) per National Kidney Foundation guidelines
- •Currently undergoing hemodialysis with a failure of previous access
- •Expected to undergo hemodialysis within 6 months of presentation
排除标准
- •Unable/refuse to abide with follow-up
- •Known hypercoagulability syndrome or a bleeding disorder
- •On a previous anticoagulant treatment
- •Intraoperative decision in favor of fistula instead of graft
- •Pregnant or breast-feeding women
- •A documented history of heparin induced thrombocytopenia or allergy
- •Active infections
- •Evidence or suspicion of central vein stenosis
研究组 & 干预措施
PROPATEN
patients with heparin-bonded graft implantation
干预措施: PROPATEN (Device)
Standard Graft
patients undergoing ePTFE hemodialysis graft implantation
干预措施: Standard Graft (Device)
结局指标
主要结局
Primary Graft Patency Rate
时间窗: 24 months after graft placement
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Primary-Assisted Graft Patency Rate
时间窗: 24 months after graft placement
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Secondary Graft Patency Rate
时间窗: 24 months after graft placement
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
次要结局
- Number of Participants With Complications or Morbidity Attributable to the Study(at least 1 year but up to two years)
- Cost Estimation and Analysis(During the study period based on an average participant follow-up of 2 years after graft placement)
- Quality of Life (QoL) Comparison(Participants would be followed for a period of 2 years after graft placement)
- Number of Postoperative Re-interventions(at least 1 year but up to two years)
研究者
Kristofer Charlton-Ouw
Associate Professor, Department of Cardiothoracic and Vascular Surgery
The University of Texas Health Science Center, Houston