Patient Blood Management in Cardiac Surgery in Turkiye
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Red blood cell transfusion
研究概览
简要总结
- Rationale and background: Surgical patients' transfusions have changed from replacing surgically lost blood with allogenic blood transfusions to implementing strategies that reduce transfusion requirements. Patient Blood Management (PBM) is designed to maintain hemoglobin concentration, optimize hemostasis, and minimize blood loss to improve patient outcomes. There is mounting evidence that multimodal PBM programs can improve postoperative outcomes and reduce perioperative blood transfusions and costs. The TULIP study in Turkey showed higher uses of blood transfusions in major surgical patients, including coronary artery surgeries in Turkey. The current studies also support the preoperative use of intravenous iron and/or vitamin B12/folic acid in major surgical patients. So, we aim to evaluate the efficacy of implantation of PBM in CABG surgeries in Turkey.
- Research question and objectives: Is it possible to decrease the amount of perioperative blood and blood products transfusions by implementing PBM in patients who underwent CABG surgeries? The primary objective of the study is to demonstrate the reduction in perioperative RBC units transfused, when PBM is implemented in cardiac surgery in Turkey. The secondary objectives are to evaluate the concurrent reduction of FFP, platelet and total blood products used as compared to a control group, length of hospital and ICU stay following the surgery.
- Study design: A prospective, multicenter, non-interventional study with a historical/retrospective control group.
- Population: Patients who are operated on for coronary artery bypass grafting.
- Variables: Demographic (age, sex), clinical (body mass index, comorbidities, ASA score, P-POSSUM score, Charlson Comorbidity Index), operative (type and duration of operations), laboratory (hemoglobin, platelet count, coagulation profile), laboratory for anemia (transferrin saturation, ferritin, creatinine clearance), preoperative treatment, transfusion data, and outcome (morbidity, mortality, lengths of hospital stay).
- Exposures: Preoperative IV iron treatment of anemia.
- Data sources: Medical data of the patients are obtained after entering a prespecified database (e-CRF) for the study subjects. For the control group, the medical data of the patients will be obtained retrospectively from the database of the TULIP study.
- Study size: Study group: A total of 368 patients from five different centers across Turkey. Control group: at least 368 patients from the same centers attending the TULIP study. Finally, 736 patients will be included for the study.
详细描述
Patient blood management (PBM) is defined as "the timely application of evidence-based medical and surgical concepts designed to maintain hemoglobin concentration, optimize haemostasis and minimize blood loss in an effort to improve patient's outcome" (1,2). Patient blood management has recently been introduced in several areas where blood transfusions are important, such as anaesthesiology, cardiac surgery, orthopedic surgery, or traumatology (3).
Its adoption has been recommended by the WHO since 2010, as well as by national health regulation agencies, international professional societies, and the European Commission (4-7). In literature, there is mounting evidence that multimodal PBM programs can be effective at improving postoperative outcomes and reducing perioperative blood transfusions and costs (8).
Turkish Society of Anaesthesiology and Reanimation (TARD) PBM Task Force has been working on this subject and studied transfusion practices in major surgery patients and the prevalence of perioperative anemia (9). In the TULIP study, unfortunately, high usage of transfusions in major surgical patients in Turkey was documented. As demonstrated in the TULIP study, one of the surgeries that had high transfusion use, was cardiac surgery. Specific procedures with the highest RBC use were also coronary artery bypass grafting (16.9% of all units). Low hemoglobin concentration was the most common indication for intra-operative RBC transfusion (57%).
Preoperative anemia is common in cardiac surgery, with a prevalence between 10% and 50% (depending on the applied definition). Using the standard World Health Organization definition, the prevalence of anemia in the adult cardiac surgery population seems to be around 20% to 30% (10). Preoperative anemia is an independent risk factor for the transfusion of RBC, postoperative morbidity, and mortality (11, 12). An analysis of 9,144 cardiac surgery patients demonstrated that patients with low hematocrit values (<25%) during surgery who were exposed to RBC transfusion had an increased morbidity (cardiac and renal) and hospital mortality (13). Preoperative anemia is mostly the result of inadequate erythropoiesis owing to iron deficiency, malnutrition, malabsorption, inflammation, bone marrow disorders, or chronic blood loss. Importantly, anemic patients with iron deficiency need to be identified as early as possible by the cardiologist, surgeon, or anesthesiologist. With the introduction of a special PBM anemia walk-in clinic, anemia management can be initiated at an early stage. This would allow for timely optimization of iron stores to compensate for iron deficiency (14) or other treatable forms of anemia. Diagnosis and treatment of preoperative anemia are currently not part of standard care but are a core element of PBM to increase Hb values in cardiac surgery patients. In recent years, many studies investigated preoperative anemia and its effects on the outcome of adult cardiac surgery patients (Table 1).
Table 1. Preoperative anemia and its effects on the outcome of adult cardiac surgery patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Signed patient informed consent
- •Male or female patient 18-80 years old
- •Patients scheduled for elective first time coronary artery bypass grafting (CABG)
- •Antiplatelet treatment will be discontinued in patients on antiplatelet therapy and will be operated after wash-out time as recommended in the guidelines. If the patient needs to be operated before wash-out period completed, then the patient will be excluded from the study.
- •Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and serum ferritin < 100 ng/ml or TSAT < 20%.
- •Patients with iron deficiency anemia in the "PBM active group" will be taken into surgery 3 weeks after the treatment for study group.
排除标准
- •Patients that undergo emergency surgical procedure
- •Patients with non-iron deficiency anaemia (thalassemia, sickle cell anemia and etc)
- •Patients with renal anemia (Hb < 130 g/L and CCL < 50 mL/min, irrespective of iron parameters) or any diagnosis that require EPO
- •Patients with Hb < 100 g/L
- •Patients with known anaphylactic/hypersensitivity reactions to parenteral iron products
- •Patients with iron overload or disturbances in utilization of iron (e.g., haemochromatosis, hemosiderosis)
- •Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range
- •Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units)
- •Patients with known myelodysplastic syndromes
- •Patients with chronic kidney disease with an estimated CCL < 50 mL/min or with end-stage renal disease requiring scheduled dialysis
- •Patients with known urinary tract infections with urea-splitting bacteria
- •Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g., due to dementia)
- •Women who are pregnant or breast feeding
- •Intention to become pregnant during the course of the study
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential),
- •Known or suspected non-compliance, drug or alcohol abuse
- •Patients who will be re-operated after being included in study
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
- •Patients receiving ≥10 units of RBCs within 24h from start of surgery.
结局指标
主要结局
Red blood cell transfusion
时间窗: 7 days
The reduction of perioperative RBC units transfused as a compared to a control group
次要结局
- Length of ICU stay(7 days)
- Length of stay(7 days)
