Antithrombin III Concentrate After Liver Transplantation

Seoul National University

Status: Completed

Conditions: Liver Transplant; Complications

Treatments: Drug: Antithrombin III, Intermittent infusion; Drug: Antithrombin III, continuous infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04219579

HGRyu_AT-III

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Continuous infusion

Experimental group

Description:

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.

Treatment:

Drug: Antithrombin III, continuous infusion

Intermittent infusion

Active Comparator group

Description:

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

Treatment:

Drug: Antithrombin III, Intermittent infusion