Tissue Plasminogen Activator Dwells to Reduce Catheter-associated Thrombosis and Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Catheter-associated Venous Thrombosis
研究概览
简要总结
The purpose of this pilot study is to test feasibility of concept, consent and enrollment rates, and mechanics of study designed to assess if intra-catheter dwells of tissue plasminogen activator (t-PA) is effective in decreasing the rate of clinically diagnosed central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE) in central venous catheters (CVC) compared to standard of care heparin dwell.
详细描述
This pilot study Children's Hospital of Wisconsin will be a prospective, blinded, randomized controlled trial enrolling 20 patients in the pediatric intensive care unit (PICU) with a newly placed central venous catheter (CVC) to receive t-PA or heparin (current standard of care and defined as placebo for this study) to dwell for a minimum of 30 minutes every three days until catheter removal or discharge from the PICU. Primary outcomes would be central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE). Secondary outcomes would be episodes of CVC dysfunction, off study use of t-PA, and bleeding.
Any patient admitted to the PICU and meeting the inclusion criteria will be approached for consent within 72 hours CVC placement. Randomization and administration of study drug/placebo treatment will be initiated within 24 hours of enrollment.
After randomization, study drug/heparin will be infused in the CVC for a dwell duration of 30 minutes-4 hours and then withdrawn (lock therapy) every 3 days until discharge from the PICU, CVC removal or a maximum of 10 doses received. Additional lumens will be treated on subsequent days. Any lumen requiring continuous infusion of vaso-active medication will not receive dwell therapy, evaluated on a day-to-day basis. Timing of instillation of study dwell medication will be adjusted so as not to interfere with medications for patient care.
This single center, pilot study will enroll 20 subjects.
Procedures to be completed for this study are as follows:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Centralized pharmacy will prepare and blind the study drug (t-PA) and the control (heparin)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0 - ≤ 18 years old
- •PICU admission
- •CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted central catheter (PICC), Broviac or Hickman, or untunneled) and in place during hospitalization
排除标准
- •Pregnancy
- •Non-English-speaking subjects and/or parent/guardian
- •Platelet count < 20,000
- •Active CVC infection-defined as positive blood culture from the in -situ CVC at time of enrollment
- •Current radiographically confirmed VTE
- •Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr, enoxaparin injections >=2mg/kg/day or >=60mg/day)
- •CVC diameter <1.9 Fr
- •Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to heparin or t-PA
- •Med-a-port catheters
研究组 & 干预措施
alteplase
patients will receive 30 min-4 hours dwells of alteplase (recombinant t-PA) (2mg/2ml, up to 2mg per dose) to central venous catheter every 3 days (maximum 10 doses)
干预措施: alteplase (recombinant t-PA) (Biological)
Heparin
patients will receive 30 min-4 hours heparin (10U/ml, up to 2 ml per dose) dwells to central venous catheter every 3 days (maximum 10 doses)
干预措施: Heparin (Drug)
结局指标
主要结局
Catheter-associated Venous Thrombosis
时间窗: 30 days or ICU discharge
Catheter-associated Venous Thrombosis upon ICU discharge or 30 days
Catheter-associated Bloodstream Infection
时间窗: 30 days or ICU discharge
CLABSI
次要结局
- Off Study Use of t-PA(30 days or ICU discharge)
- Clinical Bleeding(30 days or ICU discharge)
- Episodes of CVC Dysfunction(30 days or ICU discharge)
研究者
Sheila Hanson
Professor
Medical College of Wisconsin