Status unknownNCT04413721Updated Jun 4, 2020

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

An interventional study of RBC transfustion in Transfusion Related Complication, sponsored by RenJi Hospital. Status unknown. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 360
Allocation: Randomized
Ages: 6 Months to 36 Months
Sex: All

Study 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.

Conditions studied

Transfusion Related Complication

In context

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 36 Months
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 360 participants (estimated)

Study arms

Experimental
Short-term storage RBCs (stored for ≤ 14 days)
patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).
Procedure: RBC transfustion
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).
Procedure: RBC transfustion

Interventions

ProcedureRBC 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

What researchers measure

Primary outcomes

Mortality in in1-year after randomization
Death from all causes in1-year after randomization.
Time frame: 1-year after randomization.

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04413721
Lead sponsor: RenJi Hospital
Responsible party: Jie Tian (Dr., RenJi Hospital) — Principal investigator
First posted: Jun 4, 2020
Start date: Jul 1, 2020 (estimated)
Primary completion: Jul 1, 2023 (estimated)
Completion: Aug 1, 2024 (estimated)
Last update: Jun 4, 2020

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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