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

NCT04324255 | Unknown DMC

• 1 other identifier: 2016-0031
• Study Type: observational
• Target: 1,199
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Early allograft dysfunction

  Immediate liver graft function

  within 7 days after surgery

Secondary Outcomes (2)

• Graft failure

  90 days

• intensive care unit stay

  until the day of patients moving to general wards, through study completion, an average of 1 year

Study Arms (2)

Low ratio

Liver recipient with low preoperative von Willbrand factor-to-protein C ratio

Procedure: LT

High ratio

Liver recipient with high preoperative von Willbrand factor-to-protein C ratio

Procedure: LT

Interventions

LT PROCEDURE

Liver transplantation

High ratio; Low ratio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End-stage liver disease patients undergoing liver transplant

You may qualify if:

• patients who underwent LT

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical center

Seoul, 05505, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 27, 2020
• Study Start: January 1, 2014
• Primary Completion: December 30, 2016
• Study Completion: April 30, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)