Liver Transplant; ComplicationsNCT04324255
Von Willebrand Factor and Protein C Ratio in Graft Function After Liver Transplant
An observational study of Liver Transplant; Complications, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- LT
- Type of treatment
- Surgery or procedure
- How many people
- 1,199 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2014to 30 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage liver disease patients undergoing liver transplant
Who may be able to join
- patients who underwent LT
Who cannot join
- deceased-donor liver transplant, and insufficient data, ABO-incompatible LT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Von Willebrand Factor and Protein c Ratio-related Thrombogenicity With Systemic Inflammation is Predictive of Graft Dysfunction After Liver Transplantation: Retrospective Cohort Study
In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Such changes are thought to contribute to postoperative thrombotic complications, which may lead to early adverse events of thrombotic microangiopathy after living-donor LT (LDLT). We investigated whether vWFPCR could predict EAD or graft failure following LT and compared it with FVIIIPCR, procoagulant, such as vWF and FVIII and anticoagulant, such as PC.
- Conditions
- Liver Transplant; Complications
- Being tested
- LT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTProcedure or surgery
Liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Low ratio | Liver recipient with low preoperative von Willbrand factor-to-protein C ratio Receives: Procedure: LT | |
| High ratio | Liver recipient with high preoperative von Willbrand factor-to-protein C ratio Receives: Procedure: LT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early allograft dysfunction
Immediate liver graft function
Measured: within 7 days after surgery
Secondary outcomes (2)
Graft failure
re-liver transplantation or death, whichever was first
Measured: 90 days
intensive care unit stay
days of intensive care unit stay after liver transplant
Measured: until the day of patients moving to general wards, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Jan 2014
- Primary completion30 Dec 2016
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Retrospective
- Enrolment
- 1,199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyemee Kwon, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324255
- Sponsor's protocol ID
- 2016-0031
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The release of data is not within my permission.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Von Willebrand Factor and Protein c Ratio-related Thrombogenicity With Systemic Inflammation is Predictive of Graft Dysfunction After Liver Transplantation: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04324255
- Acronym / sponsor ID
- 2016-0031
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,199 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 27 Mar 2020 (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.
In liver cirrhosis (LC),the activity of von Willebrand factor (vWF)-cleaving enzyme ADAMTS13 is reduced in LC patients and consequent progression of liver injury. Remarkably, it has been reported that a severe vWF/ADAMTS13 imbalance develops during liver transplantation (LT) and persists even after LT. Such changes are thought to contribute to postoperative thrombotic complications, which may lead to early adverse events of thrombotic microangiopathy after living-donor LT (LDLT). We investigated whether vWFPCR could predict EAD or graft failure following LT and compared it with FVIIIPCR, procoagulant, such as vWF and FVIII and anticoagulant, such as PC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low ratio | – | Procedure: LTLiver recipient with low preoperative von Willbrand factor-to-protein C ratio |
| High ratio | – | Procedure: LTLiver recipient with high preoperative von Willbrand factor-to-protein C ratio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage liver disease patients undergoing liver transplant
Key inclusion criteria (1 listed)
- patients who underwent LT
Key exclusion criteria (1 listed)
- deceased-donor liver transplant, and insufficient data, ABO-incompatible LT
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 |
|---|---|---|
| LTLiver transplantation | Procedure or surgery | High ratio, Low ratio |
Primary outcome
Early allograft dysfunction
Time frame: within 7 days after surgery
Immediate liver graft function
2 secondary outcomes
Graft failure
Time frame: 90 days
intensive care unit stay
Time frame: until the day of patients moving to general wards, through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No. The release of data is not within my permission.
Related trials for Liver Transplant; Complications
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Transplant; Complications, run by Asan Medical Center at 1 site in South Korea.
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 27 Mar 2020. 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 South Korea. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early allograft dysfunction (time frame: within 7 days after surgery). 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 27 Mar 2020.