NCT04537000

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

August 25, 2020

Last Update Submit

August 4, 2022

Conditions

Individualized Transfusion StrategyRed Blood CellPerioperative Pediatric PatientClinical Outcome

Keywords

transfusionpediatric patientindividualized strategy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • hemoglobin （Hb） concentration

    baseline through 3 days after surgery

  • heart rate

    during operation(about 2-6 hours)

  • blood pressure（Systolic）

    during operation (about 2-6 hours)

  • blood pressure（Diastolic）

    during operation (about 2-6 hours)

  • lactate (Lac)

    during operation (about 2-6 hours)

  • +5 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

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.

study group

EXPERIMENTAL

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

Interventions

clinical condition scoreDIAGNOSTIC_TEST

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.

study group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Lavoie J. Blood transfusion risks and alternative strategies in pediatric patients. Paediatr Anaesth. 2011 Jan;21(1):14-24. doi: 10.1111/j.1460-9592.2010.03470.x.

    PMID: 21155923BACKGROUND

  • Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012 Apr 18;4(4):CD002042. doi: 10.1002/14651858.CD002042.pub3.

    PMID: 22513904BACKGROUND

  • AABB white papers: building a better patient blood management program identifying tools, soving problems and promoting patient safety; 2015

    BACKGROUND

  • Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

    PMID: 27732721BACKGROUND

  • Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630.

    PMID: 28459785BACKGROUND

  • Rouette J, Trottier H, Ducruet T, Beaunoyer M, Lacroix J, Tucci M; Canadian Critical Care Trials Group; PALISI Network. Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial. Ann Surg. 2010 Mar;251(3):421-7. doi: 10.1097/SLA.0b013e3181c5dc2e.

    PMID: 20118780BACKGROUND

  • Zhang F, Zheng ZB, Zhu ZQ, Liu DX, Liu J. Application of Perioperative Transfusion Trigger Score in Patients Undergoing Surgical Treatment of Malignant Tumor. Indian J Hematol Blood Transfus. 2020 Jan;36(1):156-163. doi: 10.1007/s12288-019-01180-z. Epub 2019 Sep 12.

    PMID: 32158099BACKGROUND

  • New HV, Grant-Casey J, Lowe D, Kelleher A, Hennem S, Stanworth SJ. Red blood cell transfusion practice in children: current status and areas for improvement? A study of the use of red blood cell transfusions in children and infants. Transfusion. 2014 Jan;54(1):119-27. doi: 10.1111/trf.12313. Epub 2013 Jun 30.

    PMID: 23808415BACKGROUND

Study Officials

  • Yun Shi, Master

    Children's Hospital of Fudan University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 3, 2020

Study Start

May 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

August 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share