Transfusion Strategies for Pediatric Liver Transplantation

Not Applicable

• Conditions: Pediatric Patients Who Need Liver Transplantation

• Registration Number: NCT02951013
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Study Start: 2016-12-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-14
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 488

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Survival rate	up to 6 months after randomization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China