Von Willebrand Factor and Protein C Ratio in Graft Functi... | NCT04324255

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

NCT04324255

Sponsor

Asan Medical Center

Status

Unknown status

Last Update Posted

Mar 27, 2020Actual

Enrollment

1,199Estimated

Phase

Not provided

Conditions

Liver Transplant; Complications

Interventions

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Dec 30, 2016Actual

Completion Date

Apr 30, 2020Estimated

First Submitted Date

Mar 21, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2020

Last Update Posted Date

Mar 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,199Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LT	Procedure	Liver transplantation	High ratio Low ratio

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent LT

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

End-stage liver disease patients undergoing liver transplant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical center		Seoul		05505	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

The release of data is not within my permission.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided