Blood Transfusion ComplicationNCT03814772
To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM
An observational study of Blood Transfusion Complication, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Blood Transfusion Complication
- What is being tested?
- Liver transplant
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 31 Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Allogeneic liver transplantation surgery
Who may be able to join
- 48h preoperative biochemical indicators, blood general indicators, coagulation test complete
Who cannot join
- 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410006
Rong Gui, +8615200828442, aguirong@163.com
About this study
Official title: To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management
Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.
Read the detailed description
- Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables.
- Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.
- Conditions
- Blood Transfusion Complication
- Being tested
- Liver transplant
- Keywords
- liver transplantation, blood transfusion, Patient blood management
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantProcedure or surgery
blood transfusion
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant | 1. 18 years to 65
2. 48h preoperative biochemical indicators, blood general indicators, coagulation test complete Receives: Procedure: Liver transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
one year mortality
All-cause mortality
Measured: 2019-2021
Secondary outcomes (1)
Intraoperative blood transfusion
Intraoperative blood component input
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start20 Mar 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion ComplicationStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, RenJi Hospital, Qilu Hospital of Shandong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814772
- Sponsor's protocol ID
- ThirdXiangyaLTP
- Status last verified
- Feb 2019
- First submitted
- 20 Jan 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management
- ClinicalTrials.gov ID
- NCT03814772
- Acronym / sponsor ID
- ThirdXiangyaLTP
- Conditions
- Blood Transfusion Complication
- Keywords
- liver transplantation, blood transfusion, Patient blood management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, RenJi Hospital, Qilu Hospital of Shandong University
- Study start
- 20 Mar 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Jan 2019 (actual)
- 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.
Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.
Detailed description
- Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables.
- Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant | – | Procedure: Liver transplant1. 18 years to 65 2. 48h preoperative biochemical indicators, blood general indicators, coagulation test complete |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Allogeneic liver transplantation surgery
Key inclusion criteria (1 listed)
- 48h preoperative biochemical indicators, blood general indicators, coagulation test complete
Key exclusion criteria (1 listed)
- 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed
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 |
|---|---|---|
| Liver transplantblood transfusion | Procedure or surgery | Liver transplant |
Primary outcome
one year mortality
Time frame: 2019-2021
All-cause mortality
1 secondary outcome
Intraoperative blood transfusion
Time frame: 2019-2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Transfusion Complication, run by The Third Xiangya Hospital of Central South University 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 21 Feb 2019. 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 Rong Gui, doctor (+8615200828442, aguirong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
one year mortality (time frame: 2019-2021). 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 21 Feb 2019.