A Randomized Controlled Clinical Trial of Transfusion Under the Guidance of West-China Perioperative Transfusion Score(WCPTS）for Massive Hemorrhagic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Proportion of patients who received red blood cells transfusion
研究概览
简要总结
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 7~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL is necessary and important in clinical practice. Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL could be calculated by their history about heart and blood pressure, and routine monitoring parameters including pulse oximetry, temperature, and the use of vasoactive medications. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.
详细描述
Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury, and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.
Guidelines for blood transfusion have been issued by many health institutions or organizations in different countries. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 7~10g/dL is based on the judgment from anesthesiologists or surgeons on the patient's condition including intravascular volume status, ongoing bleeding, any risk factors for vital organs ischemia or hypoxia, and so on. Index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL is necessary and important in clinical practice.
The aim of blood transfusion is to provide sufficient oxygen for the whole body, and to maintain the balance of oxygen supply and oxygen consumption. Factors associated with oxygen supply are hemoglobin level, cardiac output (CO), and oxygen saturation. Oxygen consumption is increased by the increase of metabolism, which could be reflected by increase of heart rate, blood pressure, and body temperature. If a patient's oxygen supply is decreased or oxygen consumption is increased, he will need a higher hemoglobin level to maintain the balance. Based on these findings, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 7/dL and 10g/dL could be calculated by their CO (reflected by the use of adrenalin), and routine monitoring parameters including pulse oximetry and core temperature.
West China Perioperative Transfusion Score (WCPTS)
The initial score is 7.
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
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 15years to 70years.
- •American Society of Anesthesiologists (ASA) physical status I, II, Ⅲ or Ⅳ.
- •Undergoing elective spine surgery with estimated blood loss more than 800ml or 20% of the patient's whole blood volume.
- •Glasgow Coma Scale (GCS) score of
- •Ability to communicate by telephone call.
- •Informed consent has been signed by the patient or his legal guardian.
排除标准
- •Declined to receive blood transfusion.
- •Refuse to sign consent.
- •Pregnancy.
- •Psychopathy.
- •Coagulopathy.
- •Impairment of communication or cognition.
- •Active participation in another trial where the primary endpoint follow-up is ongoing.
- •Unwillingness or inability to comply with protocol procedures.
研究组 & 干预措施
Hemoglobin level based on WCPTS
According to WCPTS, the patient's hemoglobin level will be maintained not less than 7,8,9,or 10g/dL. Determination of whether a patient need red blood cells transfusion is based on WCPT Score.
干预措施: Transfusion trigger based on WCPTS (Other)
Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.
干预措施: Maintenance of hemoglobin level not less than 10g/dL (Other)
结局指标
主要结局
Proportion of patients who received red blood cells transfusion
时间窗: Up to 12 weeks.
Proportion of patients who received red blood cells transfusion (Patients received red cells transfusion/ total number of the patients)
Transfusion volume of red blood cells
时间窗: Up to 12 weeks.
Volume of red blood cells transfused to the patients (units)
次要结局
- Length of ICU stay and hospitalization(Up to 12 weeks.)
- Costs of hospitalization and transfusion(Up to 12 weeks.)
- Stitches removal time(Up to six months postoperatively)
- Time to get recovery of daily life and/or working(Up to six months postoperatively)
- Healing status of surgical incision(Up to six months postoperatively)
- Hb level at different time points(Up to 12 weeks.)
- All-cause mortality in 30 days post-operatively(Up to 30 days post-operatively.)
- In-hospital complications(Up to 12 weeks.)
研究者
Ren Liao
Associated Professor of Department of Anesthesiology
West China Hospital