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

May 30, 2020 updated by: Jie Tian, RenJi Hospital

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

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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short-term storage RBCs (stored for ≤ 14 days)
patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).
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
Active Comparator: Longer-term storage RBCs (stored for ≥21 days)
patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality in in1-year after randomization
Time Frame: 1-year after randomization.
Death from all causes in1-year after randomization.
1-year after randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

May 30, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RBC20200505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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