Continuous Versus Intermittent Infusion of Human Antithrombin III Concentrate in the Immediate Postoperative Period After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Proportion of patients within target range at postoperative 72 hours
研究概览
简要总结
This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.
详细描述
Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.
The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.
A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled operation
- •Living donor liver transplantation
- •Adult patients (>=18 years old)
排除标准
- •Patients under 18 years old
- •Emergency operation
- •Deceased donor liver transplantation
研究组 & 干预措施
Continuous infusion
Immediately after operation, 2000 international unit (IU) of Antithrombin-III (AT-III) concentrate is loaded for 1 hour. AT-III concentrate 3000 IU is continuously infused through following 71 hours.
干预措施: Antithrombin III, continuous infusion (Drug)
Intermittent infusion
Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation.
干预措施: Antithrombin III, Intermittent infusion (Drug)
结局指标
主要结局
Proportion of patients within target range at postoperative 72 hours
时间窗: 72 hours after liver transplantation
Proportion of patients whose AT-III activity level is within the target range (80-120%)
次要结局
- Time required for AT-III level value to fall within target range(operation day ~ postoperative day 7)
- Proportion of patients within target range at postoperative 12/24/48/84 hours(12/24/48/84 hours after liver transplantation)
- Proportion of AT-III level values within target range(12/24/48/72/84 hours after liver transplantation)
- Bleeding requiring intervention(operation day ~ postoperative day 7)
- Duration for cessation of AT-III concentrate administration(operation day ~ postoperative day 7)
- Postoperative hospital stay(through the hospital day, an average of 14 days)
- Thrombosis event(operation day ~ postoperative day 7)
研究者
Ho Geol Ryu
Professor
Seoul National University Hospital