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Clinic Trial for West China Perioperative Transfusion Score (WCPTS) (WCPTS)

2019年11月18日 更新者:Ren Liao、West China Hospital

Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial

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 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/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 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. 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.

研究概览

详细说明

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 (TRALI), 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 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 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/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 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.

Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.

If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.

If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate >0.06μg/kg.min, or his spO2 is maintained more than 95% with >51% FiO2, or his core temperature is >40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.

The initial POTTS score is 6, and the patient's score is calculated by the sum of each item.

Score 6:The transfusion trigger is 6g/dL, and the the patient's Hemoglobin level should be maintained not less than 6g/dL.

Score 7:The transfusion trigger is 7g/dL, and the the patient's Hemoglobin level should be maintained not less than 7g/dL.

Score 8:The transfusion trigger is 8g/dL, and the the patient's Hemoglobin level should be maintained not less than 8g/dL.

Score 9:The transfusion trigger is 9g/dL, and the the patient's Hemoglobin level should be maintained not less than 9g/dL.

Score 10 or >10:The transfusion trigger is 10g/dL, and the the patient's Hemoglobin level should be maintained not less than 10g/dL.

For example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation.

研究类型

介入性

注册 (实际的)

1351

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • Department of Anesthesiology, West China Hospital, Sichuan University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 99年 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Height of usual place of residence less than 2,500 metres above sea level
  • Perioperative hemoglobin level possibly less than 10g/dL

Exclusion Criteria:

  • Emergency operation
  • ASA classification V or VI
  • Serious blood system diseases
  • Dysfunction of hemoglobin
  • Hypervolemic hemodilution
  • Tumor metastasis
  • Psychopathy
  • Refuse to sign consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Transfusion trigger based on WCPTS
Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS.
确定患者是否需要输红细胞或应维持何种血红蛋白水平是基于 WCPTS
有源比较器:Hemoglobin level 10g/dL
The patient's hemoglobin level is maintained more than 10g/dL perioperatively.
The patient's hemoglobin level is maintained more than 10g/dL perioperatively
有源比较器:Transfusion trigger based on experience
Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience.
Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of patients received red-cell
大体时间:Up to 30 days postoperatively
Proportion of patients received red-cell during peri-operative period
Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30
大体时间:Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
Up to 30 days postoperatively

次要结果测量

结果测量
措施说明
大体时间
Incidences of in-hospital infectious complications.
大体时间:Up to 30 days postoperatively
Infectious complications were defined as infection at any site, such as pulmonary infection, urinary infection, etc.
Up to 30 days postoperatively
Intensive Care Unit (ICU) admission rate
大体时间:Up to 30 days postoperatively
Proportion of patients with ICU admission
Up to 30 days postoperatively
Length of hospital stay (LOS)
大体时间:Up to 30 days postoperatively
LOS was defined as the time frame from the day of hospital admission to discharge from the hospital (unit: days).
Up to 30 days postoperatively
Hemoglobin level at different time points
大体时间:Up to 30 days postoperatively
Hb level was measured at the time points as follows: before operation, completion of operation, 24hrs after operation, before discharge, and before all red cells transfusion
Up to 30 days postoperatively
Cost of transfusion and hospitalization
大体时间:Up to 30 days postoperatively
Allogeneic blood cost and total in-hospital cost
Up to 30 days postoperatively
SF-8 questionnaire
大体时间:Up to one year postoperatively
Follow-up of quality of life during one year after operation
Up to one year postoperatively
Healing status of surgical incision
大体时间:Up to 30 days postoperatively
Healing status of surgical incision was divided into grade Ⅰ, Ⅱ, and Ⅲ. Grade Ⅰ was defined as the wound healing nicely without any adverse reaction, grade Ⅱ was defined as the inflammatory wound without the need of re-incision, and grade Ⅲ was defined as the wound suppurated with the need of re-incision for clearance.
Up to 30 days postoperatively
All-cause mortality during 1-year after operation
大体时间:Up to one year postoperatively
All-cause mortality by day-60, day-180 and 1-year after operation
Up to one year postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Ren Liao, M.D.、Department of Anesthesiology, West China Hospital, Sichuan University
  • 首席研究员:Jin Liu, M.D.、Department of Anesthesiology, West China Hospital, Sichuan University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年5月7日

初级完成 (实际的)

2017年1月20日

研究完成 (实际的)

2019年2月18日

研究注册日期

首次提交

2012年5月9日

首先提交符合 QC 标准的

2012年5月10日

首次发布 (估计)

2012年5月11日

研究记录更新

最后更新发布 (实际的)

2019年11月20日

上次提交的符合 QC 标准的更新

2019年11月18日

最后验证

2019年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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