NCT04413721

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

May 30, 2020

Last Update Submit

May 30, 2020

Conditions

Transfusion Related Complication

Outcome Measures

Primary Outcomes (1)

  • Mortality in in1-year after randomization

    Death from all causes in1-year after randomization.

    1-year after randomization.

Study Arms (2)

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

EXPERIMENTAL

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

Procedure: RBC transfustion

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

ACTIVE COMPARATOR

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

Procedure: RBC transfustion

Interventions

RBC transfustionPROCEDURE

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

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 30, 2020

First Posted

June 4, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2023

Study Completion

August 1, 2024

Last Updated

June 4, 2020

Record last verified: 2020-05