Prophylactic Anticoagulation Versus Standard Care at Central Venous Line Insertion in Critically Ill Children: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of catheter-related venous thrombosis
研究概览
简要总结
This will be a Prospective, randomized, open- label, parallel-group, center trial, which will include 80 of Children which will be admitted at Pediatric Intensive Care Unit (PICU) of Menoufia university Hospital from August 2026 to Mars 2027.
Aim of the study will be:
- Compare the incidence of clinically significant catheter-related complications (catheter occlusion requiring intervention or catheter-related thrombosis) within 14 days after CVL insertion between children receiving prophylactic anticoagulation and those receiving standard care.
- Compare time-to- first catheter occlusion.
- Compare rate of catheter-related bloodstream infection (CLABSI) within 30 days.
- Compare number of catheter manipulations and unplanned catheter removals.
- Compare major and minor bleeding events.
- Assess catheter dwell time and need for thrombolysis or therapeutic anticoagulation.
详细描述
The study population will be divided into two groups:
- Enoxaparin Group (Anticoagulation Arm):
This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients. 2. Usual Care Group (Control Arm):
This group will receive standard care without prophylactic anticoagulation.
All patients in this study will be subjected to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Children requiring a newly placed central venous line (peripherally inserted central catheter [PICC], or non-tunneled central venous catheter) for clinical care.
排除标准
- •Known major congenital bleeding diathesis or platelet count <50,000/µL at time of insertion.
- •Already on therapeutic anticoagulation for another indication.
- •Known heparin allergy or history of heparin-induced thrombocytopenia.
- •Use of dialysis catheters (study focuses on standard CVCs/PICCs).
结局指标
主要结局
Incidence of catheter-related venous thrombosis
时间窗: 14 days
Incidence (%) of catheter-related venous thrombosis within 14 days following central venous catheter placement, diagnosed using duplex ultrasonography. Both symptomatic thrombosis (clinically suspected and confirmed by imaging) and asymptomatic thrombosis (identified by protocol-specified ultrasound screening at Day 7-14) will be included. Outcome adjudication will be performed by an independent blinded committee.
次要结局
- Incidence of catheter patency(Day 7 and Day 14)
- Percentage of participants who develop catheter-related bloodstream infection, diagnosed according to CDC criteria.(30 days)
- Incidence of major bleeding(14 days)
- Incidence of minor bleeding(14 days)
- Catheter removal due to thrombosis(30 days)
- Catheter dwell time(30 days)
- All-cause in-hospital mortality(During hospitalization (up to 30 days))
研究者
Hani Hamed Saad
Lecturer of pediatrics at Faculty of medicine , Menoufia university
Menoufia University