NCT01530737已完成3 期
Antithrombin Enhancement May Improve Anticoagulation Efficiency in Infants Undergoing Cardiopulmonary Bypass for Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Chest tube volume loss
研究概览
简要总结
The primary objective of this study is:
- To evaluate the use of Antithrombin (AT) concentrate in infants less than one year of age undergoing cardiopulmonary bypass (CPB) for cardiac surgery
The secondary objectives of this study are:
- To determine if the administration of AT concentrate prior to heparinization will decrease the amount of heparin required to achieve optimal anticoagulation (as defined by anti-Xa levels) during CPB
- To determine if a decrease in activation and consumption of coagulation proteins, platelets and subsequent fibrinolysis will result in improved haemostasis following CPB
- To determine if there will be a reduction in postoperative bleeding and associated clinical complications
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 364 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients < 1 year old with cardiac defect (acquired or congenital) requiring cardiac surgery
- •Planned cardiac surgery with cardiopulmonary bypass
- •Weight > 2.5kg at the time of surgery
- •Enrolment in the CATCH main study (REB#1000020203)
排除标准
- •Preoperative antithrombin activity > 85%
- •Prematurity < 36 weeks gestational age at birth
- •Preoperative use of systemic anticoagulant (i.e. heparin or warfarin at a therapeutic dose) for > 24 hours or at any time within the 48 hours prior to surgery
- •Any form of coagulopathy or thrombophilic disorder
- •Renal (blood creatinine - estimated GRF < 60ml/min/1.73m2) or clinical liver failure
- •Antithrombin replacement therapy prior to surgery
- •Repeat surgery (including previous ECMO/VAD support as prior surgery)
- •Patients refusal to provide open consent for re-use of study data
研究组 & 干预措施
Control Group
Placebo Comparator
干预措施: Saline Placebo (Other)
Active Antithrombin Group
Experimental
干预措施: Antithrombin III (Drug)
结局指标
主要结局
Chest tube volume loss
时间窗: 24 hrs post surgery
Chest tube volume loss (mls/kg) at 24 hours in CCCU
次要结局
- Heparin dose required to achieve target Activated Clotting Time required to go on Cardiopulmonary Bypass(1hr prior to induction of anaestheisa (pre-surgery))
- Blood product transfusions intra-operatively and for the first 24 hours following surgery(24hours post surgery)
- Intraoperative coagulation profile(5 hours after start of surgery)
- Post-operative markers of platelet activation(24 and 72 hrs post surgery)
- Clinical outcomes(30 days post-surgery)
- Use of recombinant factor VIIa after surgery to control post-operative bleeding(48 hrs post surgery)
研究者
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children
研究点 (1)
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