Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Allogeneic transfusions of red blood cells
研究概览
简要总结
Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).
The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.
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)
盲法说明
Participant is blinded to group assignment
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 ≥ 30kg/m2)
- •Planned cardiac surgery
- •Age ≥ 18 years
排除标准
- •Permanent pacemaker
- •Known intolerance to protamine
- •Known or suspected allergy to the used antifibrinolytic agent
- •Refusal to receive blood products
- •Planned off pump coronary artery bypass
- •Planned peri-operative use of desmopressin
- •Known Heparin-induced thrombocytopenia
- •Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden
- •Known congenital bleeding disorders
- •Current endocarditis
- •Planned hypothermic circulatory arrest (<28C)
- •Two or more cardiac surgery procedures
- •Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
- •Planned CPB priming with red blood cells
- •Any known autoimmune disease
- •Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
- •Significant (≥50%) carotid artery stenosis
- •Patient dosed with low molecular weight Heparin less than 24h before surgery
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- •Confirmed ST elevation myocardial infarction (STEMI) within 7 days
- •Pre-operative platelet count <100,000/microliter
- •Anaemia (Hematocrit <32% for females, <35%for males)
- •Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days
- •Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery
- •International ratio (INR) >1.5 on the day of surgery in patients treated with vitamin K antagonist
- •Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
- •Renal failure (creatinine ≥ 175 micromol/L or dialysis)
- •Current thromboembolic disease other than myocardial infarct
- •Patients who have pre-donated autologous blood
- •Patient presenting with a resistance to Heparin
研究组 & 干预措施
Control group
Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: Heparin (Drug)
Control group
Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: cardiopulmonary bypass pump flow rate (Procedure)
Intervention group A
Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: Heparin (Drug)
Intervention group A
Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: cardiopulmonary bypass pump flow rate (Procedure)
Intervention group B
Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: Heparin (Drug)
Intervention group B
Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: cardiopulmonary bypass pump flow rate (Procedure)
Intervention group C
Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: Heparin (Drug)
Intervention group C
Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
干预措施: cardiopulmonary bypass pump flow rate (Procedure)
结局指标
主要结局
Allogeneic transfusions of red blood cells
时间窗: Seven days post-operatively or until discharge, whichever comes first
Percentage of subjects avoiding any allogeneic transfusions of red blood cells
次要结局
- Allogeneic transfusions of blood products(Seven days post-operatively or until discharge, whichever comes first)
- Units of blood product transfusions(Seven days post-operatively or until discharge, whichever comes first)
- Massive red blood cell transfusions(Seven days post-operatively or until discharge, whichever comes first)
- Bleeding(Peroperative, 4 and 24 hours post-operative)
- Post-operative complications(Post-operatively from day 0 up to first hospital discharge)
研究者
Pierre Voisine
Cardiac surgeon
Laval University