Transfusion Strategies for Pediatric Liver Transplantation

NCT ID: NCT02951013

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-07

Study Completion Date

2022-12-30

Brief Summary

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The patients assigned to the restrictive group will receive transfusion once the hemoglobin concentration falls below 6.0 g per deciliter, with a target hemoglobin range of 7.5 to 8.0 g per deciliter. Patients assigned to the liberal group will receive transfusion once the hemoglobin concentration falls below 8.0 g per deciliter, with a target hemoglobin range of 9.0 to 10.0 g per deciliter.

The primary outcome: Survival rate in six months after randomization.

Secondary outcomes: Incidence of perioperative complications, including sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events. Intraoperative blood loss, intraoperative blood transfusion amount, postoperative blood transfusion amount in 7 days after surgery, postoperative inflammatory reaction, mechanical ventilation time in the intensive care unit, lengths of stay in the intensive care unit and the hospital,and hospitalization expenses.

Detailed Description

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Conditions

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Pediatric Patients Who Need Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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restrictive group

Patients in this group will have a transfusion when the hemoglobin concentration falls below 6g/dL, with a target hemoglobin range of 7.5-8.0g/dL.

Group Type EXPERIMENTAL

restrictive transfusion

Intervention Type OTHER

Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL

liberal group

Patients in this group will have a transfusion when the hemoglobin concentration falls below 8g/dL, with a target hemoglobin range of 9.5-10.0g/dL.

Group Type ACTIVE_COMPARATOR

liberal transfusion

Intervention Type OTHER

Interventions

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restrictive transfusion

Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL

Intervention Type OTHER

liberal transfusion

Intervention Type OTHER

Other Intervention Names

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Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL

Eligibility Criteria

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Inclusion Criteria

* The investigators study included pediatric patients (the moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Tian

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Tian

Role: CONTACT

862168383702

Facility Contacts

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JIE TIAN, Ph.D

Role: primary

862168383702

Other Identifiers

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PLT20161023

Identifier Type: -

Identifier Source: org_study_id