Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Plasma heparin level (anti-Xa activity, in UI/ml)
研究概览
简要总结
The optimal heparin regimen during cardiopulmonary bypass (CPB) has not been well established in obese patients.
Results of a preview study show that the standard heparin management based on total body weight in obese patients during CPB resulted in excessive heparin level, which could lead to excessive postoperative bleeding.
To avoid this overdosing, an initial heparin bolus based on ideal body weight in obese patients was proposed.
The main objective of the study is to evaluate the effects of heparin injection, based on ideal body weight, on intraoperative plasma heparin levels and activated coagulation time (ACT) in a population of obese patients, compared to a group of obese patients undergoing CPB surgery with heparin management based of total body weight.
The secondary objectives are to evaluate the relationship between heparin level and ACT in each group of patients and at different time points during CPB, and to compare the incidence of bleeding, intraoperative transfusions and complications in the two groups of patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patients (BMI ≥ 30 kg/m²)
- •Planned cardiac surgery under cardiopulmonary bypass
- •Coronary-artery bypass graft, or valve surgery)
- •Age ≥ 18 yo
排除标准
- •Allergy to heparin
- •Emergency surgical intervention
- •Redo surgery
- •Heart transplantation
- •Surgery for circulatory assistance
- •Pre-operative heparin use
研究组 & 干预措施
Intervention group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB.
干预措施: Heparin, IV route, based on patients body weights (UI/kg) (Drug)
Intervention group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB.
干预措施: Cardiopulmonary bypass (Procedure)
Intervention group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the dosage of 340 UI/kg based on ideal body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on ideal body weight, to maintain this target during the CPB.
干预措施: Protamin administration (Drug)
Control group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB.
干预措施: Heparin, IV route, based on patients body weights (UI/kg) (Drug)
Control group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB.
干预措施: Cardiopulmonary bypass (Procedure)
Control group
Obese patients, randomized to receive an initial IV bolus of Heparin, before beginning of the cardiopulmonary bypass, at the usual dosage of 300 UI/kg based on total body weight of the obese patients.
The objective is to obtain an ACT target ≥ 400 s before the beginning of CPB. If necessary, additional boluses of heparin are administered at the dose of 100 UI/kg based on total body weight, to maintain this target during the CPB.
干预措施: Protamin administration (Drug)
结局指标
主要结局
Plasma heparin level (anti-Xa activity, in UI/ml)
时间窗: at 3 minutes after the first heparin injection
次要结局
- Plasma Antithrombin III level(during the intervention at 3 minutes after heparin injection (=T1))
- Activated Clotting Time(during the intervention)
- numbers of labile blood products transfused(during the surgery and the first 24 hours in ICU)
- Postoperative bleedings(during the first 24 hours in ICU, based on chest tube outputs)