Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

Study Overview
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Brief Summary
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The individualized strategies of red blood cell for perioperative pediatric patients are made based on the comparison between the clinical condition score and the Hb concentration.

Detailed Description
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The hypothesis is that the individual transfusion strategies will help to save blood resource, and meanwhile will not adversely affect the patients' clinical outcomes. Participants will be randomly divided into two groups, where the strategies of transfusion of red blood cell will be made following different principles. The strategies for patients in control group will be made by the attending doctors in charge according to the current Chinese red blood cell transfusion guidelines. For the patients in study group, the clinical condition will be identified every time red blood cell transfusion is considered. The strategies will be made according to the comparison between the score and the Hb concentration. The volume of the red blood cell used in these two groups will be compared. The number of patients who need transfusion in these two groups will be compared. The clinical outcomes will also be compared between the two groups.

Official Title
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Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

Conditions
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Individualized Transfusion Strategy, Red Blood Cell, Perioperative Pediatric Patient, Clinical Outcome

Intervention / Treatment
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* Diagnostic Test: clinical condition score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Hb concentration is tested before operation. It is higher than 7g/dl and lower than 10g/dl. Or it is anticipated that it will decrease lower than 10g/dl. Exclusion Criteria: The patient will not undergo an operation. newborn or premature baby patients accompanied with hemorrhagic disease or cyanotic heart disease patients with ischemic heart disease or ischemic cerebrovascular disease

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>The strategies of red blood cell transfusion for the pediatric patients in this group will be made by the attending doctors in charge based on the current transfusion guidelines. The attending doctors decide when to start blood red cell transfusion and order the volume of the blood red cell as the usual clinical practice. | |
| Experimental: study group<br>For study group, the clinical condition score must be identified every time red blood cell transfusion is considered. The strategies of red blood cell transfusion for the pediatric patients in this group, including the trigger and the volume, will be made based on the comparison between the clinical condition score and the Hb concentration. | Diagnostic Test: clinical condition score<br>* A score is firstly identified using a clinical condition scale including the concentration of inspired oxygen to maintain the percutaneous oxygen saturation (SPO2)≧95%, the fusion rate of catecholamine drugs to maintain normal blood pressure, the nasopharyngeal temperature and the oxygen saturation of central venous blood. The score was graded as 0, 1 and 2 points according to the patient's clinical condition. The score identified from the scale plus 7 finally makes the clinical condition score. If the score is higher than 10, it will be replaced with 10. That is to say, the highest clinical condition score is 10. If the clinical condition score≦Hb, blood red cell transfusion will not be started. If the clinical condition score>Hb, blood red cell transfusion will be started, and the volume will be calculated using the following formulation, transfusion volume(ml)=(clinical condition score - Hb)*body weight *5.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the volume of red blood cell (RBC) used adjusted to body weight | This is a repeated measurement data. The volume of RBC used adjusted to body weight = the volume of RBC (ml) used/ body weight(Kg). It is repeatedly recorded during this time frame. The data for intraoperation phase, for postoperation phase and for both intraoperation and postoperation phase are analyzed.The data would be measured at baseline (before operation), at the end of operation and on the 3rd days after operation. | baseline through 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin （Hb） concentration | Hb concentration is assessed by blood gas test. It is a repeated measurement data. | baseline through 3 days after surgery | 
| heart rate | It is a repeated measurement data. It is recorded every 5-10 minutes during this time frame . | during operation(about 2-6 hours) | 
| blood pressure（Systolic） | It is a repeated measurement data. It is (Systolic blood pressure ) recorded every 5-10 minutes during this time frame . | during operation (about 2-6 hours) | 
| blood pressure（Diastolic） | It is a repeated measurement data. It is ( Diastolic blood pressure ) recorded every 5-10 minutes during this time frame . | during operation (about 2-6 hours) | 
| lactate (Lac) | It is a repeated measurement data. It is recorded every time blood gas test is ordered during this time frame. | during operation (about 2-6 hours) | 
| length of stay in post anesthesia care unit (PACU) | the time between the arrival of the patient to the PACU to the discharge to the ward | about 2-6 hours | 
| infection | It is a binary variable. The data will be set as 1 if the patients got any infections such as wound infection, sepsis, etc. It will be set as 0 if there is no evidence for infection. | from the end of operation to the 3rd month after the operation. | 
| unexpected transfer to intense care unit (ICU) | It is a binary variable. The data will be set as 1 if the patient is transferred to ICU unexpectedly. It will set as 0 if not. | from the end of operation to the 3rd day after the operation. | 
| length of stay in hospital after operation | from the date of the operation to the date when the patient is discharged | from the date of operation to discharge （about 1-4 weeks ） | 
| the number of patients who need RBC transfusion | This is a repeated measurement data. The number of patients who need RBC transfusion during operation and during the first 3 days after operation is recorded, respectively. | baseline through 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion, pediatric patient, individualized strategy