Transfusion Strategies for Pediatric Liver Transplantation

The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial

The patients assigned to the restrictive group will receive transfusion once the hemoglobin concentration falls below 6.0 g per deciliter, with a target hemoglobin range of 7.5 to 8.0 g per deciliter. Patients assigned to the liberal group will receive transfusion once the hemoglobin concentration falls below 8.0 g per deciliter, with a target hemoglobin range of 9.0 to 10.0 g per deciliter.

The primary outcome: Survival rate in six months after randomization.

Secondary outcomes: Incidence of perioperative complications, including sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events. Intraoperative blood loss, intraoperative blood transfusion amount, postoperative blood transfusion amount in 7 days after surgery, postoperative inflammatory reaction, mechanical ventilation time in the intensive care unit, lengths of stay in the intensive care unit and the hospital，and hospitalization expenses.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Patients Who Need Liver Transplantation
• Intervention / Treatment: Other: restrictive transfusion; Other: liberal transfusion

• Study Type: Interventional
• Enrollment (Anticipated): 488
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Tian; Phone Number: 862168383702; Email: vaseline2001@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200126
      • Recruiting
      • Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
      • Contact: JIE TIAN, Ph.D; Phone Number: 862168383702; Email: vaseline2001@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The investigators study included pediatric patients (the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

• The exclusion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection, a history of liver transplantation, Multivisceral transplantation, refused to participate the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: restrictive group; Patients in this group will have a transfusion when the hemoglobin concentration falls below 6g/dL, with a target hemoglobin range of 7.5-8.0g/dL.	Other: restrictive transfusion; Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL
Active Comparator: liberal group; Patients in this group will have a transfusion when the hemoglobin concentration falls below 8g/dL, with a target hemoglobin range of 9.5-10.0g/dL.	Other: liberal transfusion; Other Names: Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival rate	up to 6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intraoperative blood transfusion		during surgery
Amount of blood transfusion during perioperative period		up to 7 days after surgery
Heart rate during surgery		during surgery
Blood pressure during surgery		during surgery
Arterial partial pressure of oxygen during surgery		during surgery
Plasma lactic acid concentration during surgery		during surgery
Oxygen uptake rate during surgery		during surgery
Daily score on Pediatric end-stage liver disease (PELD) assessment		up to 7 days after randomization
Length of Mechanical Ventilation in the intensive care unit		at discharge, an average of 2 weeks
Lengths of stay in the intensive care unit		at discharge, an average of 2 weeks
Proportion of patients who need a second hepatic surgery		up to 7 days after randomization
Hospitalization Days		at discharge, an average of 2 weeks
Out of pocket expenditure for hospitalization		at discharge, an average of 2 weeks
Incidence of severe postoperative complications before discharge	Postoperative complications include sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events.	from end of surgery till at discharge, an average of 2 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2016
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: PLT20161023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No