Risk Factors and a nOmogram of Venous thromboEmbolism in Patients After liveR Transplantation(ROVER Study)

NCT ID: NCT05209048

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 356 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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 interventions assigned to this group

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

No interventions assigned to this group

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 interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old

2. With orthotopic whole-liver transplantation

3. Liver was obtained from Brain-dead organ donors

Exclusion Criteria

1. Living donor liver transplantation, split liver transplantation, partial donor liver transplantation

2. Multivisceral or combined organ transplantation

3. Patients with preoperative VTE

4. Age < 18 years

5. Died or discontinued surgery during surgery

6. Those who died within 48 h after surgery or were discharged from hospital on their own resulting treatment discontinuity

7. Patients with incomplete clinical data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weiwei Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Chang Gung Hospital

Locations

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

19242-401

Identifier Type: -

Identifier Source: org_study_id