Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

Not Applicable

Withdrawn

• Conditions: Perioperative Pediatric Patient; Individualized Transfusion Strategy; Red Blood Cell; Clinical Outcome
• Interventions: Diagnostic Test: clinical condition score

• Registration Number: NCT04537000
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-03
• Study Start: 2021-05
• Status Verified: 2022-03
• Primary Completion: 2022-07
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	clinical condition score	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 .
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
hemoglobin （Hb） concentration	baseline through 3 days after surgery	Hb concentration is assessed by blood gas test. It is a repeated measurement data.
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 .
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.
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.
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 .