Clinical Outcome, Individualized Transfusion Strategy, Perioperative Pediatric Patient, Red Blood Cell
Conditions
Keywords
transfusion, pediatric patient, individualized strategy
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTclinical condition score
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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the volume of red blood cell (RBC) used adjusted to body weight | baseline through 3 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| heart rate | during operation(about 2-6 hours) | It is a repeated measurement data. It is recorded every 5-10 minutes during this time frame . |
| blood pressure（Systolic） | during operation (about 2-6 hours) | It is a repeated measurement data. It is (Systolic blood pressure ) recorded every 5-10 minutes during this time frame . |
| blood pressure（Diastolic） | during operation (about 2-6 hours) | It is a repeated measurement data. It is ( Diastolic blood pressure ) recorded every 5-10 minutes during this time frame . |
| lactate (Lac) | during operation (about 2-6 hours) | It is a repeated measurement data. It is recorded every time blood gas test is ordered during this time frame. |
| hemoglobin （Hb） concentration | baseline through 3 days after surgery | Hb concentration is assessed by blood gas test. It is a repeated measurement data. |
| infection | from the end of operation to the 3rd month after the operation. | 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. |
| unexpected transfer to intense care unit (ICU) | from the end of operation to the 3rd day after the operation. | 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. |
| length of stay in hospital after operation | from the date of operation to discharge （about 1-4 weeks ） | from the date of the operation to the date when the patient is discharged |
| the number of patients who need RBC transfusion | baseline through 3 days after surgery | 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. |
| length of stay in post anesthesia care unit (PACU) | about 2-6 hours | the time between the arrival of the patient to the PACU to the discharge to the ward |
Outcome results
None listed