Clinical trial NCT04537000: Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
Official title: Individualized Strategies of Red Blood Cell Transfusion for Perioperative Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Individualized Transfusion Strategy
Red Blood Cell
Perioperative Pediatric Patient
Clinical Outcome
Keywords: transfusion
pediatric patient
individualized strategy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: the volume of red blood cell (RBC) used adjusted to body weight
timeFrame: baseline through 3 days after surgery
Secondary outcomes:
measure: hemoglobin （Hb） concentration
timeFrame: baseline through 3 days after surgery
measure: heart rate
timeFrame: during operation(about 2-6 hours)
measure: blood pressure（Systolic）
timeFrame: during operation (about 2-6 hours)
measure: blood pressure（Diastolic）
timeFrame: during operation (about 2-6 hours)
measure: lactate (Lac)
timeFrame: during operation (about 2-6 hours)
measure: length of stay in post anesthesia care unit (PACU)
timeFrame: about 2-6 hours
measure: infection
timeFrame: from the end of operation to the 3rd month after the operation.
measure: unexpected transfer to intense care unit (ICU)
timeFrame: from the end of operation to the 3rd day after the operation.
measure: length of stay in hospital after operation
timeFrame: from the date of operation to discharge （about 1-4 weeks ）
measure: the number of patients who need RBC transfusion
timeFrame: baseline through 3 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Yun Shi, Master
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
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