Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Transfusion Related Complication

Treatments: Procedure: RBC transfustion

Study type: Interventional

Funder types: Other

Identifiers

NCT04413721

RBC20200505

Details and patient eligibility

About

The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days) or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion, Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital were also recorded.

Enrollment: 360 estimated patients

Sex: All

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Our study included pediatric patients (6 months< the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion criteria

• The exclu¬sion 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

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360 participants in 2 patient groups

Short-term storage RBCs (stored for ≤ 14 days)

Experimental group

Description:

patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).

Treatment:

Procedure: RBC transfustion

Longer-term storage RBCs (stored for ≥21 days)

Active Comparator group

Description:

patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days).

Treatment:

Procedure: RBC transfustion