Venous ThromboembolismNCT05209048
Risk Factors and a nOmogram of Venous thromboEmbolism in Patients After liveR Transplantation(ROVER Study)
An observational study of Venous Thromboembolism and Liver Transplantation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
Liver transplantation is currently an effective treatment for end-stage liver disease. The high incidence of thrombotic related complications in the early postoperative period after orthotopic liver transplantation(OLT) has been attributed to many factors, such as the long operation time, the high trauma, the need for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Liver Transplantation
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2021
- 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: The investigators recruited adult inpatients who received whole liver orthotopic liver transplantation in Beijing Tsinghua Changgeng hospital from August 2018 to December 2021.
Who may be able to join
- Age ≥18 years old
- With orthotopic whole-liver transplantation
- Liver was obtained from Brain-dead organ donors
Who cannot join
- Living donor liver transplantation, split liver transplantation, partial donor liver transplantation
- Multivisceral or combined organ transplantation
- Patients with preoperative VTE
- Age < 18 years
- Died or discontinued surgery during surgery
- Those who died within 48 h after surgery or were discharged from hospital on their own resulting treatment discontinuity
- Patients with incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, 102218
About this study
Official title: Risk Factors and a Nomogram of Venous Thromboembolism in Adult Patients After Orthotopic Liver Transplantation Base on a Single-center Case-control Study
Liver transplantation is currently an effective treatment for end-stage liver disease. The high incidence of thrombotic related complications in the early postoperative period after orthotopic liver transplantation(OLT) has been attributed to many factors, such as the long operation time, the high trauma, the need for prolonged bed rest after operation, and the instability of coagulation status in the early postoperative period. Among them, venous thromboembolism (VTE) is one of the most common complications after liver transplantation, including deep vein thrombosis (DVT) and pulmonary embolism (PE), which seriously affect the survival of patients after transplantation. Although the Caprini score is currently recognized as a more mature thrombotic risk assessment tool in patients undergoing abdominal surgery. However, because of the long operation time of liver transplantation and central venous catheterization and other factors, the majority of surgical patients score ≥ 5 points, which are all very high-risk grades. It loses the power of this model for risk stratification and targeted prevention. How to correctly identify people at high risk of VTE after OLT, early diagnosis of VTE and aggressive implementation of correct preventive measures appear essential. Therefore, this study was designed as a single center case-control study to review and analyze the incidence, clinical characteristics, and associated risk factors of VTE after OLT, and to establish a nomogram risk assessment model and validate its predictive efficacy.
Read the detailed description
In this study, the investigators recruited adult inpatients who underwent orthotopic liver transplantation at Tsinghua Chang Gung Memorial Hospital, Beijing, from August 2018 to December 2021. The hospitalized patients who developed VTE within 30 days after liver transplantation were screened according to the inclusion and exclusion criteria, and similarly, the negative patients were those who did not develop VTE perioperatively or who developed VTE greater than 30 days postoperatively. The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE. Data were obtained from the medical record bank of Tsinghua Chang Gung Memorial Hospital, affiliated to Tsinghua University, Beijing, China. Patient general data, laboratory test data, surgical information, etc. were extracted from the database. To analyze the incidence, clinical characteristics, and risk factors of VTE in patients after liver transplantation. Based on risk factors, a risk assessment model was built with liver transplant inpatient data from August 2018 to December 2020, and the model was validated with liver transplant inpatient data from January 2021 to December 2021.
- Conditions
- Venous Thromboembolism, Liver Transplantation
- Keywords
- VTE, OLT, Risk factor, Nomogram model
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VTE of Derivation group | VTE of Derivation group includes patients who underwent orthotopic liver transplantation on 2018.8-2020.12 and developed VTE within 30 days after operation | |
| No-VTE of Derivation group | No-VTE of Derivation group includes patients who underwent orthotopic liver transplantation on 2018.8-2020.12 and did not develop VTE within 30 days after surgery or after 30 days | |
| VTE of Validation group | VTE of Validation group includes patients who underwent orthotopic liver transplantation on 2021.1-2021.12 and developed VTE within 30 days after operation | |
| No-VTE of Validation group | No-VTE of Validation group includes patients who underwent orthotopic liver transplantation on 2021.1-2021.12 and did not develop VTE within 30 days after surgery or after 30 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of VTE after OLT
The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE.
Measured: From August 2018 to December 2021
Secondary outcomes (3)
Patients' preoperative general information
The general preoperative information of the patients included gender, age, etiology, BMI, comorbidities (hypertension, diabetes mellitus, coronary heart disease, hyperlipidemia, and history of renal insufficiency), surgical history, etc
Measured: From August 2018 to December 2021
Perioperative laboratory test indicators of patients
Laboratory test data: total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), glutamic oxalacetic transaminase (AST) glutamyltransferase (GGT), serum creatinine (SCR), serum albumin (ALB), platelet count (PLT), hemoglobin (HB), D-Dimer (D-dimer), international normalized ratio (INR), prothrombin time (APTT), etc. D-dimer was serially collected from preoperatively to 2 weeks postoperatively. For the remaining items, the test data were collected preoperatively, on postoperative day 1, and on postoperative day 7
Measured: From August 2018 to December 2021
Surgical information
Surgical information included operative method, intraoperative blood loss, plasma transfusion, red blood cell transfusion, prothrombin complex amount, liver free period time, low central venous pressure (CVP ≤ 5 cm H2O) time, operative time, ASA score, model for end stage liver disease (MELD) score, postoperative ICU stay, caprini score
Measured: From August 2018 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiwei Wu, MD, Principal investigator, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209048
- Sponsor's protocol ID
- 19242-401
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2022
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and a Nomogram of Venous Thromboembolism in Adult Patients After Orthotopic Liver Transplantation Base on a Single-center Case-control Study
- ClinicalTrials.gov ID
- NCT05209048
- Acronym / sponsor ID
- 19242-401
- Conditions
- Venous Thromboembolism, Liver Transplantation
- Keywords
- VTE, OLT, Risk factor, Nomogram model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jan 2022 (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.
Liver transplantation is currently an effective treatment for end-stage liver disease. The high incidence of thrombotic related complications in the early postoperative period after orthotopic liver transplantation(OLT) has been attributed to many factors, such as the long operation time, the high trauma, the need for prolonged bed rest after operation, and the instability of coagulation status in the early postoperative period. Among them, venous thromboembolism (VTE) is one of the most common complications after liver transplantation, including deep vein thrombosis (DVT) and pulmonary embolism (PE), which seriously affect the survival of patients after transplantation. Although the Caprini score is currently recognized as a more mature thrombotic risk assessment tool in patients undergoing abdominal surgery. However, because of the long operation time of liver transplantation and central venous catheterization and other factors, the majority of surgical patients score ≥ 5 points, which are all very high-risk grades. It loses the power of this model for risk stratification and targeted prevention. How to correctly identify people at high risk of VTE after OLT, early diagnosis of VTE and aggressive implementation of correct preventive measures appear essential. Therefore, this study was designed as a single center case-control study to review and analyze the incidence, clinical characteristics, and associated risk factors of VTE after OLT, and to establish a nomogram risk assessment model and validate its predictive efficacy.
Detailed description
In this study, the investigators recruited adult inpatients who underwent orthotopic liver transplantation at Tsinghua Chang Gung Memorial Hospital, Beijing, from August 2018 to December 2021. The hospitalized patients who developed VTE within 30 days after liver transplantation were screened according to the inclusion and exclusion criteria, and similarly, the negative patients were those who did not develop VTE perioperatively or who developed VTE greater than 30 days postoperatively. The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE. Data were obtained from the medical record bank of Tsinghua Chang Gung Memorial Hospital, affiliated to Tsinghua University, Beijing, China. Patient general data, laboratory test data, surgical information, etc. were extracted from the database. To analyze the incidence, clinical characteristics, and risk factors of VTE in patients after liver transplantation. Based on risk factors, a risk assessment model was built with liver transplant inpatient data from August 2018 to December 2020, and the model was validated with liver transplant inpatient data from January 2021 to December 2021.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VTE of Derivation group | – | –VTE of Derivation group includes patients who underwent orthotopic liver transplantation on 2018.8-2020.12 and developed VTE within 30 days after operation |
| No-VTE of Derivation group | – | –No-VTE of Derivation group includes patients who underwent orthotopic liver transplantation on 2018.8-2020.12 and did not develop VTE within 30 days after surgery or after 30 days |
| VTE of Validation group | – | –VTE of Validation group includes patients who underwent orthotopic liver transplantation on 2021.1-2021.12 and developed VTE within 30 days after operation |
| No-VTE of Validation group | – | –No-VTE of Validation group includes patients who underwent orthotopic liver transplantation on 2021.1-2021.12 and did not develop VTE within 30 days after surgery or after 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators recruited adult inpatients who received whole liver orthotopic liver transplantation in Beijing Tsinghua Changgeng hospital from August 2018 to December 2021.
Key inclusion criteria (3 listed)
- Age ≥18 years old
- With orthotopic whole-liver transplantation
- Liver was obtained from Brain-dead organ donors
Key exclusion criteria (7 listed)
- Living donor liver transplantation, split liver transplantation, partial donor liver transplantation
- Multivisceral or combined organ transplantation
- Patients with preoperative VTE
- Age < 18 years
- Died or discontinued surgery during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of VTE after OLT
Time frame: From August 2018 to December 2021
The diagnosis of VTE was confirmed as the occurrence of a critical value alert during hospitalization, which was predefined as ultrasound/radiology report of DVT or/and PE.
3 secondary outcomes
Patients' preoperative general information
Time frame: From August 2018 to December 2021
Perioperative laboratory test indicators of patients
Time frame: From August 2018 to December 2021
Surgical information
Time frame: From August 2018 to December 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
Weiwei Wu, MD principal investigator
Beijing Tsinghua Chang Gung Hospital
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 Venous Thromboembolism and Liver Transplantation, run by Beijing Tsinghua Chang Gung 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of VTE after OLT (time frame: From August 2018 to December 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 26 Jan 2022.