Transfusion Strategies for Pediatric Liver Transplantation
- Conditions
- Pediatric Patients Who Need Liver Transplantation
- Interventions
- Other: liberal transfusionOther: restrictive transfusion
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 488
- The investigators study included pediatric patients (the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
- 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
- Arm && Interventions
Group Intervention Description liberal group liberal transfusion 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. restrictive group restrictive transfusion 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.
- 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