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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04324255

Collaborator

(none)

1,199

Enrollment

Location

75.9

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications	Procedure: LT

Study Design

Study Type:

Observational

Anticipated Enrollment :

1199 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 30, 2016

Anticipated Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Early allograft dysfunction [within 7 days after surgery]
Immediate liver graft function

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical center	Seoul		Korea, Republic of	05505

Sponsors and Collaborators

Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyemee Kwon, Doctor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT04324255

Other Study ID Numbers:

2016-0031

First Posted:

Mar 27, 2020

Last Update Posted:

Mar 27, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 27, 2020