Transfusion Strategies for Pediatric Liver Transplantation

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Patients Who Need Liver Transplantation

Intervention / Treatment
-----------------
* Other: restrictive transfusion
* Other: liberal transfusion


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: restrictive group<br>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<br>* Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL<br>|
| Active Comparator: liberal group<br>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<br> <br> * 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 | Measure Description | 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 |