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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Transfusion Related Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

RBC transfustion

Intervention Type PROCEDURE

When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL

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

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

Group Type ACTIVE_COMPARATOR

RBC transfustion

Intervention Type PROCEDURE

When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL

Interventions

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RBC transfustion

When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No