NCT00265005终止1 期
Dose-Ranging, Safety And Efficacy Of Cathflo(TM) Activase(R) (Alteplase) For The Treatment Of Central Catheter Occlusion In Neonates And Infants; Phase I
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Restoration of central access device patency following one, two or three instillations of t-PA.
研究概览
简要总结
The purpose of this study is to determine if alteplase is effective in dissolving a clot in a catheter in a large vein (central venous line or PICC line) or artery in infants less than 6 months of age.
详细描述
Hospitalized patients with central access devices will be screened. Ninety subjects with at least one occluded lumen of a central access device will be eligible. Thirty subjects will be enrolled in each of the following age groups: 28-<34 weeks CGA, 34- < 40 weeks CGA, and 40 weeks to 66 weeks CGA.
Inclusion Criteria
Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent by the parent or legal guardian and comply with study assessments for the full duration of the study.
- Hospitalized premature neonates (28-< 34 weeks CGA), term neonates (34-<40 weeks CGA) and infants (40 weeks to 66 weeks CGA).
- Presence of a central access device. All types of permanent and temporary catheters are eligible [e.g., central venous catheter (CVC), peripherally-inserted central catheter (PICC), umbilical arterial catheter (UAC), or umbilical venous catheter (UVC)] except hemodialysis catheters. The catheter must be properly inserted as evidenced by the ability to have used the catheter at least once for its intended purpose (i.e., to withdraw blood and/or infuse fluids) and documentation of correct catheter placement radiographically within 48 hours of the catheter becoming non-patent.
- partial or total occlusion of at least one lumen of the catheter.
Exclusion Criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Weeks 至 66 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent by the parent or legal guardian and comply with study assessments for the full duration of the study
- •Hospitalized premature neonates (28- < 34 weeks CGA), term neonates (34 weeks-< 40 weeks CGA) and infants (> = 40 weeks to 6 months CGA).
- •Presence of central access device. All types of permanent and temporary catheters are eligible [e.g., central venous catheter (CVC), peripherally-inserted central catheter (PICC), umbilical arterial catheter (UAC), or umbilical venous catheter (UVC)] except hemodialysis catheters. The catheter must be properly inserted as evidenced by the ability to have used the catheter at least once for its intended purpose (i.e., to withdraw blood and/or infuse fluids)and documentation correct catheter placement radiographically within 48 hours of the catheter becoming non-patent.
- •Partial or total occlusion of at least one lumen of the catheter
排除标准
- •CGA > 66 weeks
- •Incorrect catheter placement or evidence of mechanical occlusion
- •Occlusion due to suspected drug precipitate
- •Active internal bleeding, involving intracranial or retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
- •Recent history (i.e., < 6 months) of intraventricular hemorrhage (IVH) or other active intracranial process that could predispose to intracranial bleeding
- •Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention
- •Any of the following known or suspected hemorrhagic events within the preceding 7 days or any other significant bleeding risk:
- •Gastrointestinal bleeding
- •Intra-ocular surgery
- •Any of the following known events or suspected hemorrhagic events within the preceding 48 hours
- •Major surgery (excluding central line placement)
- •Organ biopsy
- •Major trauma
- •Puncture of a non-compressible vessel within the previous 48 hours
- •Treatment with indomethacin within the previous 48 hours
- •Received any fibrinolytic agent within 24 hours of enrollment
- •Known risk for embolization, including history of left heart thrombus, mitral mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
- •Known hypersensitivity to alteplase or any component in the formulation of CathfloTM Activase®
- •Prior enrollment in the current study
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated or the patient has a known condition for which bleeding constitutes a significant hazard
- •Participation in another simultaneous interventional medical investigation or trial
- •Documented or suspected catheter infection
- •Thrombocytopenia (i.e. platelet count < 20,000)
研究组 & 干预措施
All
Experimental
All subjects receive active drug up to a total of 3 doses
干预措施: alteplase (Drug)
结局指标
主要结局
Restoration of central access device patency following one, two or three instillations of t-PA.
时间窗: within 180 minutes of administering the study drug
次要结局
- Restoration of patency following instillation of 1 mg/mL (i.e., first instillation)(within 60 minutes from the first instillation of study drug)
- Restoration of patency following instillation of 1 mg/mL (i.e., second instillation)(within 60 minutes from the second instillation of study drug)
- Restoration of patency following instillation of 2 mg/mL (i.e., third instillation)(within 60 minutes from the third instillation of study drug)
- The following safety outcome measure will be evaluated: • Major bleeding complications • Sepsis • Embolic events • All serious adverse events(Within 14 days of study drug administration)
研究者
Janice E. Sullivan
Professor
University of Louisville
研究点 (1)
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