Von Willebrand Factor and Protein C Ratio in Graft Function After Liver Transplant

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Procedure: LT

• Study Type: Observational
• Enrollment (Anticipated): 1199

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

End-stage liver disease patients undergoing liver transplant

Description

Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

deceased-donor liver transplant, and insufficient data, ABO-incompatible LT

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low ratio; Liver recipient with low preoperative von Willbrand factor-to-protein C ratio	Procedure: LT; Liver transplantation
High ratio; Liver recipient with high preoperative von Willbrand factor-to-protein C ratio	Procedure: LT; Liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early allograft dysfunction	Immediate liver graft function	within 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure	re-liver transplantation or death, whichever was first	90 days
intensive care unit stay	days of intensive care unit stay after liver transplant	until the day of patients moving to general wards, through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 30, 2016
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The release of data is not within my permission.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No