Antithrombin III Concentrate After Liver Transplantation

NCT ID: NCT04219579

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-03
• Study Completion Date: 2022-06-30

Brief Summary

This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.

Detailed Description

Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.

The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.

A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.

Conditions

Liver Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Continuous infusion

Immediately after operation, 2000 international unit (IU) of Antithrombin-III (AT-III) concentrate is loaded for 1 hour. AT-III concentrate 3000 IU is continuously infused through following 71 hours.

Group Type: EXPERIMENTAL

Antithrombin III, continuous infusion

Intervention Type: DRUG

Antithrombin-III is administered continuously

Intermittent infusion

Every 6 hours, 500 IU of AT-III concentrate is infused through 1 hour during the first 72 hours after liver transplantation.

Group Type: ACTIVE_COMPARATOR

Antithrombin III, Intermittent infusion

Intervention Type: DRUG

Antithrombin-III is administered intermittently

Interventions

Antithrombin III, continuous infusion

Antithrombin-III is administered continuously

Intervention Type: DRUG

Antithrombin III, Intermittent infusion

Antithrombin-III is administered intermittently

Intervention Type: DRUG

Other Intervention Names

Antithrombin III, human; Antithrombin III, human

Eligibility Criteria

Inclusion Criteria

• Scheduled operation
• Living donor liver transplantation
• Adult patients (>=18 years old)

Exclusion Criteria

• Patients under 18 years old
• Emergency operation
• Deceased donor liver transplantation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ho Geol Ryu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ho Geol Ryu, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HGRyu_AT-III

Identifier Type: -

Identifier Source: org_study_id