Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Thrombosis
研究概览
简要总结
Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?
详细描述
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA
排除标准
- •Known coagulopathy
- •History of clinically significant bleeding (GI, cranial, pulmonary)
- •Need for therapeutic heparinization
研究组 & 干预措施
Study drug
Heparin sulfate infusion at 10 units/kg/hour
干预措施: Heparin sulfate infusion at 10 units/kg/hour (Drug)
Placebo
Placebo - normal saline infusion
干预措施: Placebo infusion (Drug)
结局指标
主要结局
Thrombosis
时间窗: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
Echocardiographic evidence of thrombosis while on study drug
次要结局
- Total PRBCs Transfused(While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first))
- Need for Antibiotics(While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first))
- Cardiac ICU Length of Stay(While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first))
- Days to Extubation(While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first))
研究者
Alan Schroeder
Principal Investigator
Stanford University