Risk Factors and a nOmogram of Venous thromboEmbolism in Patients After liveR Transplantation(ROVER Study)
Risk Factors and a Nomogram of Venous Thromboembolism in Adult Patients After Orthotopic Liver Transplantation Base on a Single-center Case-control Study
1 other identifier
observational
356
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedJanuary 26, 2022
December 1, 2021
3.4 years
January 12, 2022
January 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From August 2018 to December 2021
Secondary Outcomes (3)
Patients' preoperative general information
From August 2018 to December 2021
Perioperative laboratory test indicators of patients
From August 2018 to December 2021
Surgical information
From August 2018 to December 2021
Study Arms (4)
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
Eligibility Criteria
The investigators recruited adult inpatients who received whole liver orthotopic liver transplantation in Beijing Tsinghua Changgeng hospital from August 2018 to December 2021.
You may qualify if:
- Age ≥18 years old
- With orthotopic whole-liver transplantation
- Liver was obtained from Brain-dead organ donors
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing Municipality, 102218, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weiwei Wu, MD
Beijing Tsinghua Chang Gung Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 26, 2022
Study Start
August 1, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
January 26, 2022
Record last verified: 2021-12