Clinical trial NCT01597232: Clinic Trial for West China Perioperative Transfusion Score (WCPTS)
Official title: Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfusion Related Complications
Keywords: Transfusion trigger
Hemoglobin level
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 1351
Sex: ALL
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients received red-cell
timeFrame: Up to 30 days postoperatively
measure: Composite of in-hospital complications and all-cause mortality by day-30
timeFrame: Up to 30 days postoperatively
Secondary outcomes:
measure: Incidences of in-hospital infectious complications.
timeFrame: Up to 30 days postoperatively
measure: Intensive Care Unit (ICU) admission rate
timeFrame: Up to 30 days postoperatively
measure: Length of hospital stay (LOS)
timeFrame: Up to 30 days postoperatively
measure: Hemoglobin level at different time points
timeFrame: Up to 30 days postoperatively
measure: Cost of transfusion and hospitalization
timeFrame: Up to 30 days postoperatively
measure: SF-8 questionnaire
timeFrame: Up to one year postoperatively
measure: Healing status of surgical incision
timeFrame: Up to 30 days postoperatively
measure: All-cause mortality during 1-year after operation
timeFrame: Up to one year postoperatively
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Anesthesiology, West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Anesthesiology, West China Hospital, Sichuan University
name: Ren Liao, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Anesthesiology, West China Hospital, Sichuan University
name: Jin Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: