NCT02951013

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

5.6 years

First QC Date

October 25, 2016

Last Update Submit

October 9, 2021

Conditions

Pediatric Patients Who Need Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    up to 6 months after randomization

Secondary Outcomes (14)

  • Amount of intraoperative blood transfusion

    during surgery

  • Amount of blood transfusion during perioperative period

    up to 7 days after surgery

  • Heart rate during surgery

    during surgery

  • Blood pressure during surgery

    during surgery

  • Arterial partial pressure of oxygen during surgery

    during surgery

  • +9 more secondary outcomes

Study Arms (2)

restrictive group

EXPERIMENTAL

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.

Other: restrictive transfusion

liberal group

ACTIVE COMPARATOR

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.

Other: liberal transfusion

Interventions

restrictive transfusionOTHER

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

restrictive group
liberal transfusionOTHER
Also known as: Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL
liberal group

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200126, China

RECRUITING

Study Officials

  • Jie Tian

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Tian

CONTACT

862168383702vaseline2001@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 1, 2016

Study Start

December 7, 2016

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

CN(1)