NCT00628680Unknown3 期
Pivotal/Phase III Multicentered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 Solution (Zuragen), and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis
Ash Access Technology22 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 415
- 试验地点
- 22
- 主要终点
- To show that AAT-023 (Zuragen) solution is superior to Heparin in preventing CRBSI when used as a catheter lock solution in CVCD's between hemodialysis treatments.
研究概览
简要总结
The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease patients.
详细描述
The purpose of this study is to show that AAT-023 (Zuragen) Solution is superior to Heparin in preventing Catheter Related Blood Stream Infections (CRBSI) when used as a catheter lock solution in Central Venous Catheter's for Dialysis between hemodialysis treatments (3x per week), where CRBSI's are defined as concordant bacteria found in both the catheter and peripheral blood or the exit site and peripheral blood in subjects demonstrating a temperature greater than 38 degrees celcius.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •End Stage Renal Disease 18 yrs or older.
- •CVCD with average dialysis flow rate over 300 mL/min for three most recent visits.
- •Expectation by Investigator that CVCD may be needed for up to 26 weeks.
- •Dialysis catheter is of three types a) single body with single entry and exit, b) single body with split ends, c) twin catheter with one catheter for removal of blood and another for return.
- •Kt/V >1.1 or equivalent URR
- •Negative serum pregnancy unless surgically sterile or post menopausal for >1yr.
- •Negative blood culture result from pre-enrollment blood sample draw.
- •Ability of patient to sign and understand the informed consent.
- •Most recent lab results don't indicate hypocalcemia (<7mg/dL) or thrombocytopenia (<20,000)
- •Avg. systolic blood pressure >90 mmHg as measured during the most recent three dialysis treatments.
- •Lack of signs of current blood stream infection at the beginning of the prior three dialysis treatments.
排除标准
- •A known Heparin allergy or a history of type 2 (antibody mediated) Heparin-induced thrombocytopenia.
- •Active bleeding from any site or a documented positive stool hemocult test within 28 days of enrollment in study.
- •Bloodstream infection,exit site infection or any infection requiring antibiotic use within 14 days of enrollment for any antibiotic listed in section 4.2.3 or within 30 days of enrollment for Vancomycin or any other antibiotic not listed in section 4.2.3 of the protocol
- •Inability to comply with the conditions of, or complete the protocol in the opinion of the Investigator.
- •Pregnant or breast feeding.
- •Documented allergy to sodium citrate, methylene blue, methyl/paraben and/or propyl paraben.
- •Documented chronic intrinsic coagulopathy evidenced by persistently and significantly elevated Prothrombin (INR>3), Partial Thromboplastin Time (PTT>60 seconds), or thrombocytopenia (platlet count <20,000/mm).
- •Malignancy requiring chemotherapy or radiation treatment within 180 days of enrollment.
- •Documented requirement for >5,000 units of Heparin per catheter lumen to maintain catheter patency (with decrease in blood flow demonstrated at 5,000 units per lumen Heparin catheter lock) with current catheter.
- •Contraindications to citrate or taking drugs that may interact with citrate.
- •Documented history of glucose-6-phosphate dehydrogenase deficiency (G6PD or Drug-induced methemoglobinemia).
- •Participation in another research study.
- •Co-morbidities, such as HIV, active hepatitis or recent transplants, that in the opinion of the Investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results and would make the subject inappropriate for entry into this study.
- •Unknown priming volume of catheter lumens.
- •Redness of over 1 cm diameter or pus around the catheter exit site.
研究组 & 干预措施
AAT-023 (Zuragen Arm)
Experimental
Active experimental consisting of AAT-023 (Zuragen)solution
干预措施: AAT-023 solution (Zuragen) (Device)
Heparin
Active Comparator
5000 units diluted with normal saline to the exact catheter lumen volume
干预措施: Heparin (Drug)
结局指标
主要结局
To show that AAT-023 (Zuragen) solution is superior to Heparin in preventing CRBSI when used as a catheter lock solution in CVCD's between hemodialysis treatments.
时间窗: 6 months
次要结局
- To show that AAT-023 (Zuragen) solution is non-inferior to Heparin in terms of patency failure.(6 months)
研究者
研究点 (22)
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