The Effect of Heparinization Due to LBW in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- ACT
研究概览
简要总结
High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.
详细描述
Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Closed envelope
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old, first time valve surgeries which was done on-pump.
排除标准
- •Revision valve surgeries
- •Patients with coagulation deficits
研究组 & 干预措施
Heparinisation,actual body weight
In 'Heparinisation,actual body weight' group , heparin sodium; will be done according to actual body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.
干预措施: Heparin Sodium (Drug)
Heparinisation, lean body weight
In 'Heparinisation, lean body weight' group heparin sodium will be done according to lean body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.
干预措施: Heparin Sodium (Drug)
结局指标
主要结局
ACT
时间窗: Through study completion, an average of 48 hours
Activated clotting time
次要结局
- Bleeding(Through study completion, an average of 48 hours)
研究者
Dr. Ülkü Sabuncu
Medical Doctor
Adiyaman University Research Hospital
