End Stage Liver DIseaseNCT04107883
Effect of Transfusion of Plasma on Endothelial During Liver Transplantation
A study testing fresh frozen plasma and blood sample in people with End Stage Liver DIsease and Liver Transplantation, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Liver DIsease, Liver Transplantation
- What is being tested?
- fresh frozen plasma and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child A/B cirrhosis
- patients who undergo the first OLT
- Informed and consented
- complete follow-up
- cooperate with treatment
Who cannot join
- re-transplant
- combined liver and other organ transplantation
- BMI≥30Kg/m2
- patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion
- acute liver failure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Liu Xun, 13466505725 ext. +86, 13466505725@163.com
Wu A Shi, 85231330 ext. +86 010, wuanshi@hotmail.com
About this study
Official title: Effect of Transfusion of Plasma During Orthotopic Liver Transplantation on Endothelial Glycocalyx Layer and Short-term Outcome in Patients With End-Stage Liver Disease
To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.
- Conditions
- End Stage Liver DIsease, Liver Transplantation
- Being tested
- fresh frozen plasma, blood sample
- Keywords
- endothelial, plasma
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh frozen plasmaBiological
perform plasma transfusion in different phases during perioperation
blood sampleDiagnostic test
get blood samples at several specific points in time during perioperation
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | perform artificial colloidal solution transfusion during anhapetic phase. Receives: Diagnostic Test: blood sample |
| anhapetic group | Experimental | Perform plasma transfusion during anhapetic phase. Receives: Biological: fresh frozen plasma; Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial glycocalyx layer shedding markers
plasma concentration of endothelial glycocalyx layer shedding markers
Measured: 24 hours
Secondary outcomes (1)
inflammatory cytokines
levels of inflammatory cytokines
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Liu, Beijing Chao Yang Hospital
- Investigators
- Anshi Wu, Study chair, Capital Medical University Affiliated Beijing Chaoyang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107883
- Sponsor's protocol ID
- LX-2019-LT-1
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transfusion of Plasma During Orthotopic Liver Transplantation on Endothelial Glycocalyx Layer and Short-term Outcome in Patients With End-Stage Liver Disease
- ClinicalTrials.gov ID
- NCT04107883
- Acronym / sponsor ID
- LX-2019-LT-1
- Conditions
- End Stage Liver DIsease, Liver Transplantation
- Keywords
- endothelial, plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 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.
To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Diagnostic Test: blood sampleperform artificial colloidal solution transfusion during anhapetic phase. |
| anhapetic group | Experimental | Biological: fresh frozen plasma, Diagnostic Test: blood samplePerform plasma transfusion during anhapetic phase. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Child A/B cirrhosis
- patients who undergo the first OLT
- Informed and consented
- complete follow-up
- cooperate with treatment
Key exclusion criteria (5 listed)
- re-transplant
- combined liver and other organ transplantation
- BMI≥30Kg/m2
- patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion
- acute liver failure
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 |
|---|---|---|
| fresh frozen plasmaperform plasma transfusion in different phases during perioperation | Biological | anhapetic group |
| blood sampleget blood samples at several specific points in time during perioperation | Diagnostic test | anhapetic group, control group |
Primary outcome
endothelial glycocalyx layer shedding markers
Time frame: 24 hours
plasma concentration of endothelial glycocalyx layer shedding markers
1 secondary outcome
inflammatory cytokines
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver DIsease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Anshi Wu study chair
Capital Medical University Affiliated Beijing Chaoyang 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 fresh frozen plasma and blood sample in people with End Stage Liver DIsease and Liver Transplantation, run by Beijing Chao Yang 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 5 inclusion and 5 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 24 Nov 2023. 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 Xun Liu (+86 13466505725, 13466505725@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial glycocalyx layer shedding markers (time frame: 24 hours). 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 24 Nov 2023.