Patient Blood Manegement (PBM) as Perioperative Strategy to Anemic Patients Who Will be Submitted to Coronary Artery Bypass Graft (CABG).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean number of units of Red Blood Cells (RBC)
研究概览
简要总结
Anemia poses risks during coronary artery bypass grafting (CABG), increasing complications and mortality rates. Blood transfusions in cardiac surgery have negative outcomes, prompting the use of erythropoietin in Patient Blood Management (PBM) to limit transfusion needs and enhance postoperative recovery. EPO can reduce blood component requirements, adverse events, and inflammation in anemic CABG patients. A study aims to minimize transfusions through a PBM anemia treatment protocol for CABG patients, comparing outcomes in three groups: a Control Group (CG), a Non-PBM Group (NPBMG) treated with blood components, and a PBM Group (GPBM) treated with EPO. Parameters include post-op stay, mortality, cardiovascular events, non-cardiovascular events, ICU time, mechanical ventilation duration, vasoactive drug use, inflammatory responses, and cardiac cell death. Analysis will consider demographic and clinical factors, with expectations that GPBM will yield superior results compared to NPBMG and similar or better outcomes than CG.
详细描述
Anemia increases the risk of postoperative complications and mortality in patients undergoing coronary artery bypass grafting (CABG). In addition, the use of blood transfusions during cardiac surgery is associated with adverse effects and unfavorable outcomes. To reduce the need for transfusions and improve post-operative results, erythropoietin is used as part of Patient Blood Management (PBM). In anemic patients undergoing CABG, the use of Erythropoietin (EPO) can eliminate the need for blood components during and after surgery, as well as reduce adverse events and inflammation. The objectives of the proposed study are to reduce or eliminate the number of transfusions in the intraoperative and postoperative context by means of a Patient Blood Management (PBM) anemia treatment protocol for anemic patients who will undergo Coronary Artery Bypass Graft Surgery (CABG). The proposed study is a prospective, non-controlled interventional study to be carried out with anemic patients awaiting CABG surgery at Hospital São Paulo. There will be three groups of 40 participants each: Control Group (CG) of non-anemic individuals preoperatively; Non- PBM Group (NPBMG) of anemic individuals preoperatively and treated with blood components according to need; PBM Group (GPBM) of anemic individuals preoperatively and treated with EPO. The following parameters will be compared: length of postoperative hospital stay; mortality; postoperative cardiovascular events: clinical stroke, perioperative infarction, surgical reoperation due to bleeding; non- cardiovascular events: surgical site-associated infection and acute renal dysfunction; time in postoperative intensive care; time on mechanical ventilation; need for vasoactive drug use; inflammatory process and intra- and postoperative cardiac cell death. Confounding factors such as demographic and clinical parameters will be included in the analysis. It is expected that the GPBM will obtain the best results in relation to the GNPBM, similar to or better than the CG.
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, Care Provider)
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
- 是
入选标准
- •Eletive surgery;
- •Only CABG as procedure;
- •Off pump CABG candidate.
排除标准
- •Age > 80 years;
- •Chronic dialytic kidney disease;
- •Chronic rheumatologic disease;
- •Men with Hb levels > 13 g/dl and < 8g/dl;
- •Women with Hb levels > 12 g/dl and < 8g/dl;
- •Presence of another heart disease requiring surgical intervention;
- •Presence of hepatic insufficiency;
- •Presence of any implantable electronic cardiac device in any cardiac chambers;
- •Pregnancy;
- •Diagnosis of malignant neoplasia;
- •Thrombophilias;
- •Need for Erythropoietin treatment due to any other disease.
- •Recent ischemic event (< 3 months).
- •Ejection fraction <30%.
研究组 & 干预措施
Randomized Anemia Group for non-PBM protocol (GNPBM)
Patients > 18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hemoglobin - Hb < 12g/dl in women and < 13g/dl in men)
干预措施: blood transfusion (Procedure)
Randomized Anemia Group for PBM protocol (GPBM)
Patients >18 years admitted to Hospital São Paulo for Coronary Artery Bypass Grafting (CABG) surgery who are hospitalized in the Cardiovascular Surgery department or another specialty unit and are anemic (Hb < 12g/dl in women and < 13g/dl in men)
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Mean number of units of Red Blood Cells (RBC)
时间窗: Until perioperative day 3
Compare the need of blood transfusion in the perioperative period
次要结局
- Perioperative infection(Until perioperative day 3)
- Bleeding(From time of admission on ICU until hour 24th after admission (accountable amount from how many chest tubes the patient was admitted).)
- Hemoglobin levels(Until perioperative day 3 and at discharge)
- Need of Dyalisis (Acute Kidney Disease)(Based on KDIGO classification of Acute Kdney Injury, level III of the classification. (Up to 120 hours from ICU admission, accountable from the time Dyalisis is indicated).)
- Inflammatory response(Until perioperative day 3)
- Cardiovascular mortality(From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (any cardiovascular reason as main cause of death accountable as in-hospital mortality).))
- Length of ICU stay(From time of admission after surgery to time of clinical conditions of discharge (time of ICU medical discharge, not time of ICU room exit). Up to 240 hours.)
- Length of mechanical ventilation(From time of intubation by anesthesia team until time of extubation by ICU team (Up to 240 hours).)
- Stroke(Until perioperative day 3)
- Length of hospital stay(From time of ICU medical discharge until time of Hospital discharge (Up to 14 days).)
- Epigenetics alterations(Until perioperative day 3)
- Perioperative myocardial infarction(Until perioperative day 3)
- All-cause mortality(From day of the intervention (if intervention group) or from the moment of surgery (if control group) until day of hospital discharge (death from any cause accountable as in-hospital mortality).)
研究者
LEONARDO OHASHI
MD
Federal University of São Paulo