Pediatric Patients Who Need Liver Transplantation
Conditions
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.
Interventions
Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL
OTHERliberal transfusion
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate | up to 6 months after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Amount of intraoperative blood transfusion | during surgery | — |
| 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 | 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. |
| Daily score on Pediatric end-stage liver disease (PELD) assessment | up to 7 days after randomization | — |
Countries
China
Contacts
Primary ContactJie Tian
Outcome results
None listed