Pediatric Patients Who Need Liver TransplantationNCT02951013
Transfusion Strategies for Pediatric Liver Transplantation
A study testing restrictive transfusion and liberal transfusion in people with Pediatric Patients Who Need Liver Transplantation, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Pediatric Patients Who Need Liver Transplantation
- What is being tested?
- restrictive transfusion and liberal transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2016to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The investigators study included pediatric patients (the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
Who cannot join
- The exclusion 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200126
JIE TIAN, Ph.D, 862168383702, vaseline2001@hotmail.com
About this study
Official title: The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial
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.
- Being tested
- restrictive transfusion, liberal transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrictive transfusionOther
Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL
liberal transfusionOther
Also called Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: liberal transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: up to 6 months after randomization
Secondary outcomes (14)
Amount of intraoperative blood transfusion
Measured: during surgery
Amount of blood transfusion during perioperative period
Measured: up to 7 days after surgery
Heart rate during surgery
Measured: during surgery
Blood pressure during surgery
Measured: during surgery
Arterial partial pressure of oxygen during surgery
Measured: during surgery
Plasma lactic acid concentration during surgery
Measured: during surgery
Oxygen uptake rate during surgery
Measured: during surgery
Daily score on Pediatric end-stage liver disease (PELD) assessment
Measured: up to 7 days after randomization
Length of Mechanical Ventilation in the intensive care unit
Measured: at discharge, an average of 2 weeks
Lengths of stay in the intensive care unit
Measured: at discharge, an average of 2 weeks
Proportion of patients who need a second hepatic surgery
Measured: up to 7 days after randomization
Hospitalization Days
Measured: at discharge, an average of 2 weeks
Out of pocket expenditure for hospitalization
Measured: at discharge, an average of 2 weeks
Incidence of severe postoperative complications before discharge
Postoperative complications include sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events.
Measured: from end of surgery till at discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start7 Dec 2016
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Who Need Liver TransplantationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Tian, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951013
- Sponsor's protocol ID
- PLT20161023
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2016
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Liberal or Restrictive Transfusion in Pediatric Liver Transplantation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02951013
- Acronym / sponsor ID
- PLT20161023
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| restrictive group | Experimental | Other: restrictive transfusionPatients 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. |
| liberal group | Active comparator | Other: liberal transfusionPatients 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. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The investigators study included pediatric patients (the moon's age <36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.
Key exclusion criteria (1 listed)
- The exclusion 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| restrictive transfusionTransfusion will start when the hemoglobin concentration falls below 6.0 g/dL | Other | restrictive group |
| liberal transfusionAlso: Transfusion will start when the hemoglobin concentration falls below 8.0 g/dL | Other | liberal group |
Primary outcome
Survival rate
Time frame: up to 6 months after randomization
14 secondary outcomes
Amount of intraoperative blood transfusion
Time frame: during surgery
Amount of blood transfusion during perioperative period
Time frame: up to 7 days after surgery
Heart rate during surgery
Time frame: during surgery
Blood pressure during surgery
Time frame: during surgery
Arterial partial pressure of oxygen during surgery
Time frame: during surgery
Plasma lactic acid concentration during surgery
Time frame: during surgery
Oxygen uptake rate during surgery
Time frame: during surgery
Daily score on Pediatric end-stage liver disease (PELD) assessment
Time frame: up to 7 days after randomization
Length of Mechanical Ventilation in the intensive care unit
Time frame: at discharge, an average of 2 weeks
Lengths of stay in the intensive care unit
Time frame: at discharge, an average of 2 weeks
Proportion of patients who need a second hepatic surgery
Time frame: up to 7 days after randomization
Hospitalization Days
Time frame: at discharge, an average of 2 weeks
Out of pocket expenditure for hospitalization
Time frame: at discharge, an average of 2 weeks
Incidence of severe postoperative complications before discharge
Time frame: from end of surgery till at discharge, an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Tian principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restrictive transfusion and liberal transfusion in people with Pediatric Patients Who Need Liver Transplantation, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Tian (862168383702, vaseline2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: up to 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.