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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04413721
• Collaborator: (none)
• Enrollment: 360
• Arms: 2
• Anticipated Duration (Months): 49

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transfusion Related Complication	Procedure: RBC transfustion	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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).	Procedure: 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
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; 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

Outcome Measures

Primary Outcome Measures

1. Mortality in in1-year after randomization [1-year after randomization.]

   Death from all causes in1-year after randomization.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 36 Months
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jie Tian, Dr., RenJi Hospital
• ClinicalTrials.gov Identifier: NCT04413721
• Other Study ID Numbers: RBC20200505
• First Posted: Jun 4, 2020
• Last Update Posted: Jun 4, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 4, 2020