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

Liver Transplant; Complications Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04324255
• Other study ID #: 2016-0031
• Status: Active, not recruiting
• Start date: January 1, 2014
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1199
• Est. completion date: April 30, 2020
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Procedure:
• LT
Liver transplantation

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early allograft dysfunction	Immediate liver graft function	within 7 days after surgery
Secondary	Graft failure	re-liver transplantation or death, whichever was first	90 days
Secondary	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