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

Not Applicable

• Conditions: Transfusion Related Complication
• Interventions: Procedure: RBC transfustion

• Registration Number: NCT04413721
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Last Update Submitted: 2020-05-30
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Study Start: 2020-07-01
• Primary Completion: 2023-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-term storage RBCs (stored for ≤ 14 days)	RBC transfustion	patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).
Longer-term storage RBCs (stored for ≥21 days)	RBC transfustion	patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days).

Primary Outcome Measures

Name	Time	Method
Mortality in in1-year after randomization	1-year after randomization.	Death from all causes in1-year after randomization.