Clinical trial NCT02951013: Transfusion Strategies for Pediatric Liver Transplantation
Official title: The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Patients Who Need Liver Transplantation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 488
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival rate
timeFrame: up to 6 months after randomization
Secondary outcomes:
measure: Amount of intraoperative blood transfusion
timeFrame: during surgery
measure: Amount of blood transfusion during perioperative period
timeFrame: up to 7 days after surgery
measure: Heart rate during surgery
timeFrame: during surgery
measure: Blood pressure during surgery
timeFrame: during surgery
measure: Arterial partial pressure of oxygen during surgery
timeFrame: during surgery
measure: Plasma lactic acid concentration during surgery
timeFrame: during surgery
measure: Oxygen uptake rate during surgery
timeFrame: during surgery
measure: Daily score on Pediatric end-stage liver disease (PELD) assessment
timeFrame: up to 7 days after randomization
measure: Length of Mechanical Ventilation in the intensive care unit
timeFrame: at discharge, an average of 2 weeks
measure: Lengths of stay in the intensive care unit
timeFrame: at discharge, an average of 2 weeks
measure: Proportion of patients who need a second hepatic surgery
timeFrame: up to 7 days after randomization
measure: Hospitalization Days
timeFrame: at discharge, an average of 2 weeks
measure: Out of pocket expenditure for hospitalization
timeFrame: at discharge, an average of 2 weeks
measure: Incidence of severe postoperative complications before discharge
timeFrame: from end of surgery till at discharge, an average of 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jie Tian
role: PRINCIPAL_INVESTIGATOR
References: