Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

August 4, 2022 updated by: Children's Hospital of Fudan University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the volume of red blood cell (RBC) used adjusted to body weight
Time Frame: 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.
baseline through 3 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin （Hb） concentration
Time Frame: baseline through 3 days after surgery
Hb concentration is assessed by blood gas test. It is a repeated measurement data.
baseline through 3 days after surgery
heart rate
Time Frame: during operation(about 2-6 hours)
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）
Time Frame: 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 .
during operation (about 2-6 hours)
blood pressure（Diastolic）
Time Frame: 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 .
during operation (about 2-6 hours)
lactate (Lac)
Time Frame: 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.
during operation (about 2-6 hours)
length of stay in post anesthesia care unit (PACU)
Time Frame: about 2-6 hours
the time between the arrival of the patient to the PACU to the discharge to the ward
about 2-6 hours
infection
Time Frame: 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.
from the end of operation to the 3rd month after the operation.
unexpected transfer to intense care unit (ICU)
Time Frame: 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.
from the end of operation to the 3rd day after the operation.
length of stay in hospital after operation
Time Frame: 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
from the date of operation to discharge （about 1-4 weeks ）
the number of patients who need RBC transfusion
Time Frame: 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.
baseline through 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Chair: Yun Shi, Master, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • transfusion-08-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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