Clinical Trial of West-China Perioperative Transfusion Score (WCPTS）for Massive Hemorrhagic Surgery
- Conditions
- Transfusion Related Complications
- Interventions
- Other: Maintenance of hemoglobin level not less than 10g/dLOther: Transfusion trigger based on WCPTS
- Registration Number
- NCT01345643
- Lead Sponsor
- Ren Liao
- Brief Summary
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.
- Detailed Description
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.
If a patient's cardiac output (CO) is normal without continuous infusion of adrenalin, or his SpO2 is more than 95%, or his core temperature is less than 38℃, he doesn't have any bonus point factor, and his score is 7.
If a patient's CO is maintained in normal range by continuous adrenalin infusion with concentration of less than 0.05μg/kg.min, or his SpO2 is 85\~94%, or his core temperature is 38\~40℃, his score should be added 1 point for every item mentioned above.
If a patient's CO is only maintained by continuous adrenalin infusion with concentration of more than 0.05μg/kg.min, or his SpO2 is less than 84%, or his core temperature is above 40℃, his score should be added 2 points for every item mentioned above.
For example, if a patient's CO is normal, his SpO2 is more than 95%, and his core temperature is 39℃,his WCPTS should be calcultaed as 7 plus 1 (core temperature is 39℃), and his final score is 8.
Here's another example, if a patient's CO is normal, his core temperature is less than 38℃, but he has COPD and his SpO2 is less than 84%, his score could be calculated as 7 plus 2(SpO2 is less than 84%), and his final score is 9.
Value of SaO2 is evaluated 5min after endotracheal intubation with inhalation of compressive air.
The initial score is 7，and the patient's score is calculated by 7 plus the sum of every item.
Score 7：To maintain the patient's Hb level not less than 7g/dL
Score 8：To maintain the patient's Hb level not less than 8g/dL
Score 9：To maintain the patient's Hb level not less than 9g/dL
Score 10 or \>10：To maintain the patient's Hb level not less than 10g/dL
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemoglobin level 10g/dL Maintenance of hemoglobin level not less than 10g/dL The patient's hemoglobin level is maintained not less than 10g/dL perioperatively. Hemoglobin level based on WCPTS Transfusion trigger 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.
- Primary Outcome Measures
Name Time Method Proportion of patients who received red blood cells transfusion 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 Up to 12 weeks. Volume of red blood cells transfused to the patients (units)
- Secondary Outcome Measures
Name Time Method Length of ICU stay and hospitalization Up to 12 weeks. From admission to ICU to discharge from ICU
Costs of hospitalization and transfusion Up to 12 weeks. All the medical costs.
Stitches removal time Up to six months postoperatively The time period (days) from the day of operation to the day of stitches removal
Time to get recovery of daily life and/or working Up to six months postoperatively Tthe time period (weeks) from the day of discharge to the day that patient get recovery of normal daily life and/or working during a six-month follow-up.
Healing status of surgical incision Up to six months postoperatively Healing status is 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.
Hb level at different time points Up to 12 weeks. Hb level at admission, 1 day before surgery, during operation, 1,2,3 days after surgery, before discharge
All-cause mortality in 30 days post-operatively Up to 30 days post-operatively. Death for any reason within 30 days post-operatively
In-hospital complications Up to 12 weeks. In-hospital complications include: (1) Cardiac and pulmonary events such as cardiac arrest, arrhythmia, heart failure, pulmonary edema, etc. (2) Febrility without antibiotic treatment. (3) Infection needed antibiotic treatment. (4) Re-operation for bleeding. (5) Deep venous thrombosis. (6) Other complications.
Trial Locations
- Locations (1)
West China Hosptial, Sichuan University
🇨🇳Chengdu, Sichuan, China