Transfusion Strategies for Pediatric Liver Transplantation

Shanghai Jiao Tong University

Status: Unknown

Conditions: Pediatric Patients Who Need Liver Transplantation

Treatments: Other: liberal transfusion; Other: restrictive transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02951013

PLT20161023

Details and patient eligibility

About

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.

Enrollment: 488 estimated patients

Sex: All

Ages: Under 36 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

488 participants in 2 patient groups

restrictive group

Experimental group

Description:

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.

Treatment:

Other: restrictive transfusion

liberal group

Active Comparator group

Description:

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.

Treatment:

Other: liberal transfusion