Antithrombin III Concentrate After Liver Transplantation

N/ACompletedNCT04219579

Seoul National University Hospital130 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

130

Conditions

Liver Transplant; Complications

Interventions

Antithrombin III, continuous infusionDRUG

Antithrombin-III is administered continuously

Antithrombin III, Intermittent infusionDRUG

Antithrombin-III is administered intermittently

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of patients within target range at postoperative 72 hours

Proportion of patients whose AT-III activity level is within the target range (80-120%)

Time frame: 72 hours after liver transplantation

Secondary Outcomes

Proportion of patients within target range at postoperative 12/24/48/84 hours

Proportion of patients whose AT-III activity level is within the target range (80-120%)

Time frame: 12/24/48/84 hours after liver transplantation

Proportion of AT-III level values within target range

Among the measured AT-III activity levels, proportion of the values within the target range (80-120%)

Time frame: 12/24/48/72/84 hours after liver transplantation

Time required for AT-III level value to fall within target range

Time required for AT-III level value to fall within target range (80-120%, hours)

Time frame: operation day ~ postoperative day 7

Duration for cessation of AT-III concentrate administration

AT-III infusion is stopped for 24 hours when AT-III plasma activity level exceeds 120%, then restarted after the value is confirmed to be less than 120%.

Time frame: operation day ~ postoperative day 7

Bleeding requiring intervention

Time frame: operation day ~ postoperative day 7

Thrombosis event

Hepatic artery thrombosis, portal vein thrombosis

Time frame: operation day ~ postoperative day 7

Data from ClinicalTrials.gov

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