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
Conditions
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.