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Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04537000
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Individualized Transfusion Strategy Red Blood Cell Perioperative Pediatric Patient Clinical Outcome Diagnostic Test: clinical condition score Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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 .

  3. 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 .

  4. 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 .

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537000


Contacts
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Contact: Yun Shi, Master 086-13918268351 imulashi@yahoo.com

Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: Yun Shi, Master Children's Hospital of Fudan University
More Information
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Publications:
AABB white papers: building a better patient blood management program identifying tools, soving problems and promoting patient safety; 2015

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04537000    
Other Study ID Numbers: transfusion-08-2020
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
transfusion
pediatric patient
individualized strategy