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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| restrictive group | Experimental | 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. |
|
| liberal group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| restrictive transfusion | Other | Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | up to 6 months after randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Tian | Contact | 862168383702 | vaseline2001@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Tian | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital affliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200126 | China |
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| liberal transfusion | Other |
|
|
| 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 |